[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"lymph-node-metastases\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:lymph-node-metastases":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,13,0,[8,48,82,108,142,166,192,219,244,270,293,335,356],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100537486","phase-1-safety-and-efficacy-of-nrt6008-in-patients-with-unresectable-locally-advanced-pancreatic-cancer-lapc-and-advanced-pancreatic-cancer-with-lymph-node-metastases-100537486",false,"NCT06278454","Safety and Efficacy of NRT6008 in Patients With Unresectable Locally Advanced Pancreatic Cancer (LAPC) and Advanced Pancreatic Cancer With Lymph Node Metastases","A Phase I Study to Evaluate the Safety, Tolerance and Efficacy of NRT6008 Injection in Unresectable Locally Advanced Pancreatic Cancer (LAPC) and Advanced Pancreatic Cancer With Lymph Node Metastases","Inclusion Criteria:\n\n1. Aged ≥18 years and ≤80 years, able to comprehend and sign an informed consent form;\n2. Diagnosed with pancreatic adenocarcinoma confirmed histologically or cytologically;\n3. Evaluated as unresectable LAPC or metastatic pancreatic cancer with lymph node metastasis only, as determined by the investigator; or having contraindications to surgery, or refusing surgical resection;\n4. ECOG performance status score ≤1;\n5. Expected survival ≥3 months;\n6. According to RECIST v1.1 criteria, there is only one measurable lesion in the pancreas confirmed by imaging, and the lesion has the shortest axis diameter ≥2.0 cm, the longest axis diameter ≤6.0 cm (based on baseline imaging);\n7. Adequate normal organ and marrow function as defined below: (1) Renal function: serum creatinine ≤1.5×ULN, or creatinine clearance ≥60 mL\u002Fmin (calculated by the Cockcroft-Gault formula); (2) Liver function: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤3×ULN; serum total bilirubin ≤1.5×ULN; (3) Bone marrow function \\[\\[no blood transfusion or granulocyte colony-stimulating factor (G-CSF), human thrombopoietin (TPO), or TPO receptor agonist treatment within 14 days prior to signing informed consent\\]: neutrophils ≥1.5×10\\^9\u002FL, hemoglobin ≥90 g\u002FL, platelets ≥100×10\\^9\u002FL; (4) Coagulation function: International normalized ratio (INR) or prothrombin time (PT) ≤1.5×ULN, and activated partial thromboplastin time (APTT) ≤1.5×ULN;\n8. Female and male participants of reproductive age must voluntarily agree to practice strict and effective contraception after signing the informed consent form, during the study period, and within 12 months after administration of the investigational drug. Males are prohibited from donating sperm during this period. Female participants of reproductive age must have a negative pregnancy test result during the screening period and within 24 hours before administration of the investigational drug.\n\nExclusion Criteria:\n\n1. Allergic to the investigational drug NRT6008 injection itself or any of its components;\n2. Contraindications to any of the three optional systemic chemotherapy regimens in this study judged by investigators;\n3. Previous anti-tumor treatments for pancreatic cancer, including but not limited to chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc. Except for discontinuation of traditional chinese medicine or herbal medicine for at least 7 days prior to the screening period;\n4. Contraindications to anesthesia;\n5. History of any other malignant tumors within 5 years before receiving investigational drug treatment, except for cases of cured non-melanoma skin cancer, cervical carcinoma in situ, or basal cell carcinoma of the skin, Stage I Grade 1 endometrial carcinoma, or thyroid cancer;\n6. Presence or suspected presence of distant metastases according to imaging;\n7. Pregnant or lactating females;\n8. Participants assessed by the investigators to be at high risk or had difficulty in operation for EUS-FNI procedures;\n9. Evidence of radiographic invasion into stomach, duodenum or peritoneum;\n10. Participants with chronic diseases that are actively treated but not well controlled, such as primary hypertension, diabetes, etc.;\n11. Within 6 months prior to the the first administration of chemotherapy, occurrence of acute pancreatitis, severe gastrointestinal bleeding, severe cardiovascular diseases (including but not limited to stroke, unstable angina), or occurrence of acute infections requiring systemic treatment within 2 weeks before the screening period;\n12. Participated in other interventional clinical trials within 1 month prior to the first administration of chemotherapy;\n13. Positive for human immunodeficiency virus (HIV) antibodies;\n14. Positive for hepatitis B virus (HBV) surface antigen (HBsAg) and\u002For hepatitis B core antibody (HBcAb), HBV DNA testing required, participants with HBV-DNA levels below the lower limit of the reference range or \\\u003C 500 IU\u002FmL will be eligible for inclusion in this study (use of antiviral drugs during the study period is required);\n15. Positive for hepatitis C virus (HCV) antibodies, HCV RNA testing required, participants with negative HCV RNA results will be eligible for inclusion in this study;\n16. Participants with syphilis infection or active tuberculosis;\n17. Other reasons deemed unsuitable for participation in this trial by the investigators.","ALL","18 Years","80 Years",{"count":20,"type":21},58,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This is a single arm, open label, multi-center phase I study, including phase Ia dose escalation and phase Ib dose expansion. Safety review committee (SRC) will be formed to monitor safety and efficacy data through the study. And the independent review committee (IRC) will be formed to monitor efficacy data through the study.",[27,28,29],"Unresectable Pancreatic Cancer","Advanced Pancreatic Cancer","Lymph Node Metastases",[31,32,33,34],"Yttrium-90","Endoscopic ultrasound-guided fine-needle injection","Locally Advanced Pancreatic Carcinoma","Advanced Pancreatic Cancer with Lymph Node Metastases","RECRUITING","2026-06-08",{"date":38,"type":39},"2026-06-10","ACTUAL",{"date":41,"type":39},"2024-01-09",{"date":43,"type":21},"2028-06",{"name":45,"class":46},"Chengdu New Radiomedicine Technology Co. LTD.","INDUSTRY",6,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":61,"conditions":62,"keywords":65,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":4},"100635401","comparison-of-68gaga-ctr-fapi-and-18f-fdg-petmri-for-lymph-node-staging-in-rectal-cancer-100635401","NCT07552207","Comparison of [68Ga]Ga-CTR-FAPI and 18F-FDG PET\u002FMRI for Lymph Node Staging in Rectal Cancer","Comparison of the Diagnostic Efficacy of [68Ga]Ga-CTR-FAPI PET\u002FMRI and 18F-FDG PET\u002FMRI for Lymph Node Metastasis in Middle to High Rectal Cancer","PKUCH-R12","Inclusion Criteria:\n\n* Confirmed rectal adenocarcinoma by pathological biopsy.\n* Lower margin of the tumor is ≥ 5 cm and ≤15 cm from the anal verge.\n* Planned to undergo radical surgery.\n* ECOG performance status score ≤ 2.\n* Patient is willing to undergo PET\u002FMRI examination.\n\nExclusion Criteria:\n\n* History of pelvic radiotherapy or chemotherapy.\n* Concurrent with other malignant tumors or active infections.\n* Pregnant or unable to sign the informed consent form.\n* Claustrophobia or inability to tolerate MRI examinations due to other reasons.","75 Years",{"count":58,"type":21},30,[60],"NA","This is a prospective, single-center, diagnostic study designed to compare the accuracy of \\[68Ga\\]Ga-CTR-FAPI PET\u002FMRI and \\[18\\]F-FDG PET\u002FMRI for the detection of lymph node metastasis in patients with initially untreated, resectable middle to high rectal cancer. The study aims to evaluate whether \\[68Ga\\]Ga-CTR-FAPI PET\u002FMRI provides higher sensitivity and specificity than traditional 18F-FDG PET\u002FMRI at both the patient level and the lymph node level.",[63,29,64],"Rectal Cancer","PET \u002F MR",[66,67,68,69,70],"PET\u002FMR","[68Ga]Ga-CTR-FAPI","18F-FDG","Lymph Node Staging","Radiomics","NOT_YET_RECRUITING","2026-04-28",{"date":74,"type":39},"2026-05-04",{"date":76,"type":21},"2026-04-01",{"date":78,"type":21},"2028-12-31",{"name":80,"class":81},"Peking University Cancer Hospital & Institute","OTHER",{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":90,"minAge":17,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":22,"phases":93,"briefSummary":94,"conditions":95,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":107},"100439325","dutch-national-randomized-study-psma-petct-as-a-triage-tool-for-pelvic-lymph-node-dissection-in-prostatectomy-patients-100439325","NCT05000827","Dutch National Randomized Study: PSMA-PET\u002FCT As a Triage Tool for Pelvic Lymph Node Dissection in Prostatectomy Patients","Multi-institutional Evaluation of the Cost-effectiveness of PSMA-PET\u002FCT for the Detection of Pelvic Lymph Node Invasion in Newly Diagnosed Prostate Cancer Patients","PSMA-SELECT","Inclusion Criteria:\n\n* Biopsy proven adenocarcinoma of the prostate\n* Indication for ePLND combined with robot assisted radical prostatectomy (RARP) (MSKCC nomogram \\>5%, if not applicable when only MRI targeted biopsies are positive, the Briganti nomogram will be used)\n* Suitable for robot-assisted ePLND and RARP\n* Mentally competent and understanding of benefits and potential burden of the study\n* Written informed consent\n* No known allergies for PSMA tracer.\n\nExclusion Criteria:\n\n* History of prior diagnosed or treated PCa\n* Known concomitant malignancies (except Basal Cell Carcinoma of the skin)\n* Unwillingness or inability to undergo PSMA PET\u002FCT and\u002For ePLND and RARP\n* PSMA non-avid PCa (local tumor activity)\n* Presence of distant metastasis (M1)","MALE",{"count":92,"type":21},706,[60],"To determine if the use of Prostate-Specific Membrane Antigen Positron Emission Computer Tomography (PSMA PET\u002FCT) as a selection tool for performing extended lymph node dissection (ePLND) for prostate cancer (PCa) in the primary staging setting results in fewer ePLND procedures and therefore lower overall healthcare costs, lower patient burden in terms of intervention-related complications and morbidity, with comparable disease prognosis, compared to the current European Guideline-recommended standard practice which includes performing ePLND in PCa patients who are candidates for active treatment with a nomogram-calculated lymph node involvement (LNI) risk \\>5%.",[96,97,29],"Prostate Cancer Metastatic","Prostate Cancer","2025-02-19",{"date":100,"type":39},"2025-02-21",{"date":102,"type":39},"2021-07-28",{"date":104,"type":21},"2026-08-31",{"name":106,"class":81},"Canisius-Wilhelmina Hospital",1,{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":116,"minAge":17,"maxAge":4,"enrollmentInfo":117,"targetDuration":4,"studyType":22,"phases":119,"briefSummary":120,"conditions":121,"keywords":126,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":141},"100414047","targeted-axillary-dissection-tad-in-early-stage-node-positive-breast-cancer-100414047","NCT04671511","Targeted Axillary Dissection (TAD) in Early-stage Node Positive Breast Cancer","Sentinel Node Biopsy and Targeted Axillary Dissection in Node-Positive Breast Cancer Patients With Clinically Negative Axilla","TADEN","Inclusion Criteria:\n\n* Participants must be ≥ 18 years old.\n* Participants with a clinical T1 or T2 invasive ductal or lobular breast carcinoma, regardless of estrogen\u002Fprogesterone\u002Fhuman epidermal growth factor receptor 2 (HER2) receptor status.\n* Participants with clinical (on palpation) N0 and up to two suspicious lymph nodes on axillary ultrasound.\n* Participant with biopsy-proven positive axillary disease made by core needle biopsy or fine-needle aspiration.\n* Participants must have an Eastern Cooperative Oncology Group (ECOG) Scale of Performance Status less than 2.\n* Participants must understand, accept, and have signed the approved consent form.\n\nExclusion Criteria:\n\n* Participant with previous ipsilateral axillary surgery, including sentinel lymph node biopsy.\n* Participants with distant metastases.\n* Participants that have had previous radiotherapy to the axillary nodes.\n* Participants who received neoadjuvant therapy.\n* If the injection of blue dye is planned, patients with hypersensitivity or allergy to isosulfan blue, patent blue, methylene blue or radiocolloid dye.\n* Participants who are unable to provide informed consent.","FEMALE",{"count":118,"type":21},98,[60],"RATIONALE: It is now standard for most breast cancer patients with 1-2 positive sentinel nodes to avoid completion node dissection when eligibility criteria from the American College of Surgeons Oncology Group (ACOSOG) Z0011 trial are met. The National Comprehensive Cancer Network (NCCN) recently proposed to extend this indication to patients that present with biopsy proven node positive disease if only 1 or 2 suspicious nodes are found on imaging, these positive nodes are not palpable clinically, and the other eligibility criteria from the Z0011 study are otherwise met. However, this recommendation is based on an expert consensus and no study has yet confirmed the optimal method to stage the axilla in this patient population.\n\nPURPOSE: Evaluate the technical success rate and accuracy of sentinel node biopsy (SNB) and the potential benefits of clipping and removing the biopsy proven node using radioactive seed localisation (RSL) (SNB+RSL = Targeted Axillary Dissection (TAD)) in patients with biopsy proven positive nodes, limited nodal disease in imaging and clinically negative axillary examination.",[122,123,29,124,125],"Breast Cancer Female","Early-stage Breast Cancer","Axillary Metastases","Sentinel Lymph Node",[127,128,129,130,131],"breast cancer","targeted axillary dissection","sentinel lymph node biopsy","clinically negative axilla","metastatic axillary lymph nodes","2025-02-18",{"date":134,"type":39},"2025-02-20",{"date":136,"type":39},"2021-03-30",{"date":138,"type":21},"2026-07",{"name":140,"class":81},"Jewish General Hospital",3,{"id":143,"slug":144,"hasResults":11,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":4,"eligibilityCriteria":148,"healthyVolunteers":11,"sex":116,"minAge":17,"maxAge":149,"enrollmentInfo":150,"targetDuration":4,"studyType":22,"phases":152,"briefSummary":153,"conditions":154,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":107},"100419652","targeted-resection-of-axillary-metastatic-lymph-nodes-after-breast-cancer-neoadjuvant-chemotherapy-100419652","NCT04744506","Targeted Resection of Axillary Metastatic Lymph Nodes After Breast Cancer Neoadjuvant Chemotherapy","Targeted Axillary Dissection Using Carbon Marking for Patients With Node-positive Breast Cancer Following Neoadjuvant Therapy (TADCOM): a Prospective, Multicenter, Randomized Controlled Trial","Inclusion Criteria:\n\n1. Female patients aged 18 to 85 years are eligible.\n2. Participants must have a histologically confirmed diagnosis of breast cancer, classified as cT1-4N1-2aM0 according to the 8th edition of the AJCC (American Joint Committee on Cancer) TNM classification system.\n3. Eastern Cooperative Oncology Group (ECOG) performance status must be 0 or 1.\n4. Clinical re-staging must indicate an axillary node status of ycN0 following NAC.\n5. Participants must provide written informed consent to partake in the trial, acknowledging understanding and agreement to the procedures and risks involved.\n\nExclusion Criteria:\n\n1. Patients with metastatic breast cancer (Stage IV).\n2. Diagnosed with inflammatory breast cancer or bilateral breast cancer.\n3. History of axillary surgical procedures.\n4. Any medical, psychological, or social conditions that would prevent adherence to the study protocol or completion of the treatment or follow-up.\n5. Known allergy to carbon nanoparticles or presence of severe comorbid conditions or other serious underlying medical issues.\n6. Current or prior participation in another clinical trial that could interfere with the outcome of this study or affect the safety and well-being of the participants.","85 Years",{"count":151,"type":21},126,[60],"This study evaluates the efficacy and feasibility of Carbon Nanoparticle Suspension Injection (CNSI) for Targeted Axillary Dissection (TAD) in breast cancer patients undergoing neoadjuvant chemotherapy (NAC), compared to traditional clip-based methods. By leveraging CNSI's enhanced visibility and stability, the study aims to improve the precision of lymph node removal, reduce surgical complications, and potentially transform clinical practices. Conducted across multiple centers, this randomized controlled trial focuses on clinical outcomes such as lymph node retrieval rates and the accuracy of surgical staging, aiming to establish a safer, more effective approach to managing axillary lymph nodes in breast cancer surgery.",[155,156,29],"Breast Cancer","Surgery","2025-02-09",{"date":159,"type":39},"2025-02-12",{"date":161,"type":39},"2024-11-30",{"date":163,"type":21},"2029-07-15",{"name":165,"class":81},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"id":167,"slug":168,"hasResults":11,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":172,"eligibilityCriteria":173,"healthyVolunteers":11,"sex":116,"minAge":17,"maxAge":56,"enrollmentInfo":174,"targetDuration":4,"studyType":22,"phases":176,"briefSummary":177,"conditions":178,"keywords":180,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":191},"100313867","sentinel-node-mapping-in-high-risk-endometrial-cancer-100313867","NCT03366051","Sentinel Node Mapping in High Risk Endometrial Cancer","Sentinel Node Mapping Versus Sentinel Node Mapping With Systematic Lymphadenectomy in High Risk Endometrial Cancer: a Open Label, Non-inferiority, Randomized Trial.","ALICE","Inclusion Criteria:\n\n* High grade histologies (endometrioid grade 3, serous, clear cell and carcinosarcoma)\n* Endometrioid grades 1 or 2 with myometrial invasion of ≥50%\n* Endometrioid grades 1 or 2 with cervical invasion\n* Clinically suitable to receive systematic lymphadenectomy\n* Consent statement\n\nExclusion Criteria:\n\n* Previous hysterectomy in other institution\n* Presence of extra-uterine disease (peritoneal, visceral or suspicious lymph node metastasis)\n* Previous pelvic node dissection",{"count":175,"type":21},178,[60],"This study will evaluate the role of systematic lymphadenectomy after sentinel node (SLN) mapping in high risk endometrial cancer (high grade histologies or deep myometrial invasion). The participants will be randomized in a non-inferiority controlled trial in 2 groups: SLN mapping or SLN mapping followed by systematic lymphadenectomy.",[179,29],"Endometrial Cancer",[179,125,181],"Lymphadenectomy","2024-07-29",{"date":184,"type":39},"2024-07-30",{"date":186,"type":39},"2017-12-22",{"date":188,"type":21},"2024-12-20",{"name":190,"class":81},"AC Camargo Cancer Center",5,{"id":193,"slug":194,"hasResults":11,"nctId":195,"briefTitle":196,"officialTitle":196,"acronym":197,"eligibilityCriteria":198,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":199,"targetDuration":201,"studyType":202,"phases":4,"briefSummary":203,"conditions":204,"keywords":206,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":218},"100302879","distribution-of-lymph-node-metastases-in-esophageal-carcinoma-100302879","NCT03222895","Distribution of Lymph Node Metastases in Esophageal Carcinoma","TIGER","Inclusion Criteria:\n\n* Primary squamous cell or adenocarcinoma of the esophagus or esophago-gastric junction\n* Surgically resectable (cT1-4a, N0-3, M0)\n* Adequate physical condition to undergo transthoracic surgery (ASA 1-3)\n* Transthoracic esophagectomy\n\nExclusion Criteria:\n\n* Previous thoracic or abdominal (upper GI) surgery disturbing lymph drainage of the esophagus and stomach\n* Patients with in situ carcinoma or high grade dysplasia",{"count":200,"type":21},5000,"5 Years","OBSERVATIONAL","Background: Lymph node status is an important prognostic parameter in esophageal carcinoma and an independent predictor of survival. Distribution of metastatic lymph nodes may vary with tumor location, tumor histology, tumor invasion depth and neoadjuvant therapy. Surgical strategy depends on the distribution pattern of nodal metastases but consensus on the extent of lymphadenectomy differs worldwide. Especially for adenocarcinoma the distribution of lymph node metastases has not yet been described in large series. Aim of the present study is to evaluate the distribution of lymph node metastases in esophageal carcinoma specimens following transthoracic esophagectomy with at least a 2-field lymphadenectomy.\n\nMethods: The TIGER-study is a multinational observational cohort study. All patients with a resectable esophageal or gastro-esophageal junction carcinoma in whom a transthoracic esophagectomy with a 2- or 3-field lymphadenectomy is performed in participating centers will be included. All lymph node stations will be excised and separately sent for pathological examination. Cluster analysis will be performed to identify patterns of metastases in relation to tumor location, tumor histology, tumor invasion depth and neoadjuvant therapy.\n\nConclusion: TIGER will provide a roadmap of the location of lymph node metastases in relation to tumor histology, tumor location, invasion depth, number of lymph nodes and lymph node metastases, pre-operative diagnostics, neo-adjuvant therapy and survival. Patient-tailored treatment can be developed on the basis of these results, such as the the optimal radiation field and extent of lymphadenectomy based on the primary tumor characteristics.",[205,29],"Esophageal Neoplasms",[205,207,208],"Lymph node metastases","Esophagectomy","2024-02-12",{"date":211,"type":39},"2024-02-13",{"date":213,"type":39},"2019-03-01",{"date":215,"type":21},"2028-06-01",{"name":217,"class":81},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)",19,{"id":220,"slug":221,"hasResults":11,"nctId":222,"briefTitle":223,"officialTitle":224,"acronym":225,"eligibilityCriteria":226,"healthyVolunteers":11,"sex":116,"minAge":17,"maxAge":4,"enrollmentInfo":227,"targetDuration":4,"studyType":22,"phases":229,"briefSummary":231,"conditions":232,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":235,"startDateStruct":237,"completionDateStruct":239,"leadSponsor":241,"locationsCount":243},"100445169","phase-2-groningen-international-study-on-sentinel-nodes-in-vulvar-cancer-iii-100445169","NCT05076942","Groningen International Study on Sentinel Nodes in Vulvar Cancer-III","Groningen International Study on Sentinel Nodes in Vulvar Cancer-III, a Prospective Phase II Treatment Trial","GROINSS-VIII","Inclusion Criteria:\n\n* Histological confirmed primary SCC of the vulva\n* T1 tumor, not encroaching urethra\u002Fvagina\u002Fanus\n* Depth of invasion \\> 1mm\n* Tumor diameter \\\u003C 4cm\n* Unifocal tumor\n* No enlarged (\\>1.5cm) or suspicious inguinofemoral lymph nodes at imaging (CT\u002FMRI\u002Fultrasound)\n* Possibility to obtain informed consent\n* Metastatic sentinel lymph node; size of metastasis \\> 2mm and \u002F or extracapsular extension, or\n* Metastatic sentinel lymph node: more than 1 SN with metastasis ≤ 2mm\n* Patients are able to understand requirements of study, provide written informed consent and comply with the study and follow-up procedures\n* Adequate bone marrow, renal and liver function:\n\n  * Absolute neutrophil count ≥ 1.5 x 109 \u002FL\n  * Platelet count ≥ 100 x 109 \u002FL\n  * Creatinine clearance ≥ 40 ml\u002Fmin measured by the Cockroft Gault formula\n  * Total bilirubin \\\u003C 1.25 x ULN Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULN\n* Performance status of 0, 1 or 2 on the Eastern Cooperative Oncology Group (ECOG) Scale (Appendix A)\n* Age 18 years or older\n* Life expectancy of ≥ 12 weeks\n* Written informed consent\n\nExclusion Criteria:\n\n* Inoperable tumors and tumors \\> 4cm\n* Multifocal tumors\n* Tumors with other pathology than squamous cell carcinoma\n* Patients with enlarged \u002F suspicious lymph nodes which are proven metastatic after fine needle aspiration cytology\n* No other carcinomas, other than basal cell carcinomas, within last 5 years\n* History of pelvic radiotherapy\n* History of any infection requiring hospitalization or antibiotics within 2 weeks before enrollment\n* Pregnant female or nursing mother\n* Desire to become pregnant\n* Known brain or spinal cord metastases unless adequately treated (surgery or radiotherapy) with no evidence of progression and neurologically stable off anticonvulsants and steroids\n* Unstable angina, myocardial infarction, cerebrovascular accident, \\> Class II congestive heart failure according to the New York Heart Association Classification for Congestive Heart Failure (see Appendix B) within 6 months before enrollment",{"count":228,"type":21},157,[230],"PHASE2","Vulvar cancer patients with SN-metastasis \\> 2mm will receive chemoradiation instead of an inguinofemoral lymphadenectomy.",[233,125,29],"Vulvar Cancer","2023-07-27",{"date":236,"type":39},"2023-08-01",{"date":238,"type":39},"2021-01-01",{"date":240,"type":21},"2029-01-01",{"name":242,"class":81},"University Medical Center Groningen",27,{"id":245,"slug":246,"hasResults":11,"nctId":247,"briefTitle":248,"officialTitle":249,"acronym":4,"eligibilityCriteria":250,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":251,"enrollmentInfo":252,"targetDuration":4,"studyType":22,"phases":253,"briefSummary":254,"conditions":255,"keywords":257,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":262,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":107},"100436159","lymph-node-mapping-via-flourescent-dye-in-colon-cancer-100436159","NCT04959604","Lymph Node Mapping Via Flourescent Dye in Colon Cancer","Lymph Node Mapping Via the Flourescent Dye ICG in Colon Cancer Through Preoperative Application","Inclusion Criteria:\n\n* histologically diagnosed carcinoma of the ascending, transverse, descending or sigmoid colon.\n\nExclusion Criteria:\n\n* not wanting to participate\n* other carcinoma then adenocarcinoma\n* endoscopic marking not possible","100 Years",{"count":58,"type":21},[60],"The aim of the study is to evaluate whether lymph nodes draining the region of the carcinoma are located only inside the lines of standard resection or in some percentages are located outside as well. The visualized nodes draining the region of the carcinoma will be correlated to location, fluorescent yes\u002Fno and nodal positive\u002Fnegative.\n\nThe draining lymph nodes will be visualized using the fluorescent dye indocyanine green.\n\nThe aim of the study is to evaluate whether lymph nodes draining the region of the carcinoma are located only inside the lines of standard resection or in some percentages are located outside as well. The visualized nodes draining the region of the carcinoma will be correlated to location, fluorescent yes\u002Fno and nodal positive\u002Fnegative.\n\nThe draining lymph nodes will be visualized using the fluorescent dye indocyanine green.",[256,29],"Colon Carcinoma",[258,259,260],"indocyanine green","lymphatic mapping","fluorescence","2023-05-21",{"date":263,"type":39},"2023-05-23",{"date":265,"type":39},"2021-05-31",{"date":267,"type":21},"2026-12-30",{"name":269,"class":81},"Universitätsklinikum Hamburg-Eppendorf",{"id":271,"slug":272,"hasResults":11,"nctId":273,"briefTitle":274,"officialTitle":275,"acronym":276,"eligibilityCriteria":277,"healthyVolunteers":11,"sex":116,"minAge":17,"maxAge":4,"enrollmentInfo":278,"targetDuration":201,"studyType":202,"phases":4,"briefSummary":280,"conditions":281,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":283,"lastUpdatePostDateStruct":284,"startDateStruct":286,"completionDateStruct":288,"leadSponsor":290,"locationsCount":292},"100399843","minimal-invasive-axillary-staging-and-treatment-after-neoadjuvant-systemic-therapy-in-node-positive-breast-cancer-100399843","NCT04486495","Minimal Invasive Axillary Staging and Treatment After Neoadjuvant Systemic Therapy in Node Positive Breast Cancer","Minimal Invasive Axillary Staging and Treatment After Neoadjuvant Systemic Therapy in Node Positive Breast Cancer (MINIMAX): a Dutch Multicenter Observational Study to Gain Insight in Less and More Invasive Axillary Staging and Treatment in Relation to Oncologic Safety and Quality of Life to Develop Evidence-based Guidelines.","MINIMAX","Inclusion Criteria:\n\n* Female patient with unilateral invasive breast cancer and cN1-3\n* Pathologically proven positive axillary lymph node\n* Planned to undergo neoadjuvant chemotherapy (± immunotherapy), followed by staging and treatment of the breast and axilla\n\nExclusion Criteria:\n\n* Clinically node negative breast cancer before NST\n* Bilateral invasive breast cancer\n* Neoadjuvant endocrine therapy\n* Distant metastases (including oligometastatic disease)\n* History of invasive breast cancer\n* Other malignancies, except for basal\u002Fsquamous cell skin cancer, and in situ carcinoma of the cervix or breast\n* Axillary surgery or radiotherapy before NST (this includes SLNB prior to NST)",{"count":279,"type":21},549,"Today, the majority of clinically node positive (cN+) breast cancer patients is treated with neoadjuvant systemic therapy (NST). Axillary staging and treatment after NST in cN+ patients are areas of controversy. Patients with a pathological complete response (pCR) of the axillary lymph nodes are not expected to benefit from axillary lymph node dissection (ALND). Hence, less invasive axillary staging procedures are being introduced to avoid unnecessary ALND. However, evidence supporting the safety of replacing ALND by less invasive techniques in terms of oncologic safety and impact on quality of life (QoL) is lacking.",[155,282,29],"Neoadjuvant Therapy","2022-08-23",{"date":285,"type":39},"2022-08-24",{"date":287,"type":39},"2020-07-16",{"date":289,"type":21},"2027-07-01",{"name":291,"class":81},"Maastricht University Medical Center",35,{"id":294,"slug":295,"hasResults":11,"nctId":296,"briefTitle":297,"officialTitle":298,"acronym":299,"eligibilityCriteria":300,"healthyVolunteers":11,"sex":116,"minAge":17,"maxAge":4,"enrollmentInfo":301,"targetDuration":4,"studyType":202,"phases":4,"briefSummary":303,"conditions":304,"keywords":313,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":326,"lastUpdatePostDateStruct":327,"startDateStruct":329,"completionDateStruct":331,"leadSponsor":333,"locationsCount":107},"100393503","the-role-of-micrometastasis-and-isolated-tumor-cells-itcs-in-endometrial-and-cervical-cancer-a-multicenter-study-100393503","NCT04403867","The Role of Micrometastasis and Isolated Tumor Cells (ITCs) in Endometrial and Cervical Cancer. A Multicenter Study.","The Role of Micrometastasis and Isolated Tumor Cells (ITCs) in Uterine Cancers (Endometrial\u002FCervical) Submitted to Sentinel Lymph Nodes (SLN) Procedure: an Observational Study","ITCMicroUtCa","Inclusion Criteria:\n\n* Early stage endometrial cancer scheduled for SLN procedure\n* Early stage cervical cancer scheduled for SLN procedure\n* Pathological evaluation of SLNs with standard ultra-staging or one-step nucleic acid amplification (OSNA) for the detection of metastasis\n* Presence of lymph nodes metastasis (macrometastasis or low volume disease \\[micrometastasis and isolated tumor cells\\])\n\nExclusion Criteria:\n\n* Previous (\\\u003C5 years) or concomitant malignancy other than non-melanoma skin cancer\n* Advanced\u002Fmetastatic endometrial cancer\n* Locally advanced\u002Fmetastatic cervical cancer",{"count":302,"type":21},500,"The role of small-volume lymph node disease (ITC and micro metastases) among patients with endometrial or cervical cancer submitted to sentinel node (SLN) procedure is not clearly defined.\n\nThis study was designed to create a dataset of patients with lymph nodal disease. Data on type and volume of lymph nodal disease, therapeutic choices and oncological outcomes (DFS, OS, recurrence rate) will be collected and analyzed.\n\nThis will allow to define the groups of patients who may need or for whom it can be avoided any adjuvant treatment on the basis of lymph node status.",[179,305,125,306,307,308,309,310,311,29,312],"Cervical Cancer","Micrometastasis","Sentinel Lymph Node Biopsy","Endometrium Tumor","Endometrial Neoplasms","Cervical Neoplasm","Cervical Tumor","Lymph Node Disease",[314,315,316,317,318,319,320,321,322,323,324,325],"endometrial cancer","cervical cancer","sentinel lymph node","low volume disease","survival","recurrence rate","adjuvant therapy","micrometastases","isolated tumor cell","macrometastases","ultrastaging","one-step nucleic acid amplification (OSNA)","2022-08-15",{"date":328,"type":39},"2022-08-17",{"date":330,"type":39},"2020-01-02",{"date":332,"type":21},"2027-01",{"name":334,"class":81},"Fondazione IRCCS Istituto Nazionale dei Tumori, Milano",{"id":336,"slug":337,"hasResults":11,"nctId":338,"briefTitle":339,"officialTitle":340,"acronym":4,"eligibilityCriteria":341,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":342,"targetDuration":4,"studyType":22,"phases":344,"briefSummary":345,"conditions":346,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":347,"lastUpdatePostDateStruct":348,"startDateStruct":350,"completionDateStruct":352,"leadSponsor":354,"locationsCount":4},"100348202","the-dissection-of-lymph-node-posterior-to-right-recurrent-laryngeal-nerve-for-papillary-thyroid-carcinoma-100348202","NCT03813706","the Dissection of Lymph Node Posterior to Right Recurrent Laryngeal Nerve for Papillary Thyroid Carcinoma","Prospective Study for the Dissection of Lymph Node Posterior to Right Recurrent Laryngeal Nerve for Papillary Thyroid Carcinoma","Inclusion Criteria:\n\n* Phase I:\n\n  1. aged from 18 years old to 80 years old;\n  2. the primary treatment of patients with right or bilateral PTC;\n  3. patients will voluntarily enter the study after informed consent.\n\nPhase II:\n\n1. aged from 18 years old to 80 years old;\n2. the primary treatment of patients with right or bilateral PTC predicted to have no LN-prRLN metastasis by the \"prediction model of LN-prRLN\";\n3. patients will voluntarily enter the study after informed consent.\n\nExclusion Criteria:\n\n1. patients refused to participate in the study;\n2. non first operation patients;\n3. other malignant tumor history;\n4. distant metastasis;\n5. history of neck trauma.",{"count":343,"type":21},4000,[60],"This study was completed in two stages. In the first stage, 2000 participants were enrolled according to the criteria. Following the principle of informed consent and voluntary consent of patients, the standard operation was \"right or bilateral thyroidectomy + isthmus resection + right area VI lymph node dissection + left area VI lymph node dissection + lateral neck lymph node dissection\". The age of participants, the size of right thyroid tumors, the invasion of the capsule and the number of lateral neck lymph node metastasis were counted to validate and improve the predictive model of lymph node posterior to the right recurrent laryngeal nerve in papillary thyroid cancer (Y=-0.029×age+0.771×tumor size+0.660×capsular invasion+1.331×right lateral lymph node metastasis-1.687, Y ≥0.16 means right recurrent laryngeal nerve posterior lymph node metastasis).\n\nIn the second stage, 2000 participants assessed by the model without posterior right recurrent laryngeal nerve metastasis were randomly divided into experimental group and control group according to the principle of informed consent and voluntary. The right recurrent laryngeal nerve posterior lymph nodes were not dissected in experimental group, while the right recurrent laryngeal nerve posterior lymph nodes were routinely dissected in control group. Through long-term follow-up and comparison of RFS and OS between the two groups, the investigators can scientifically evaluate the effectiveness of the \"prediction model of lymph node posterior to right recurrent laryngeal nerve metastasis in papillary thyroid carcinoma\", and seek evidence for accurate treatment of lymph node posterior to the right recurrent laryngeal nerve in thyroid papillary carcinoma.",[29],"2019-07-02",{"date":349,"type":39},"2019-07-05",{"date":351,"type":21},"2020-01",{"date":353,"type":21},"2040-12",{"name":355,"class":81},"Zhejiang University",{"id":357,"slug":358,"hasResults":11,"nctId":359,"briefTitle":360,"officialTitle":361,"acronym":4,"eligibilityCriteria":362,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":363,"targetDuration":4,"studyType":22,"phases":365,"briefSummary":366,"conditions":367,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":347,"lastUpdatePostDateStruct":368,"startDateStruct":369,"completionDateStruct":370,"leadSponsor":371,"locationsCount":4},"100348161","central-cervical-dissection-for-clinical-node-negative-papillary-thyroid-carcinoma-100348161","NCT03813173","Central Cervical Dissection for Clinical Node Negative Papillary Thyroid Carcinoma","Central Cervical Dissection for Clinical Node Negative Papillary Thyroid Carcinoma: a Prospective Study","Inclusion Criteria:\n\n* Phase I and II:\n\n  1. aged 18 to 80 years old;\n  2. the primary treatment of patients with unilateral or bilateral PTC;\n  3. ultrasound showed that the tumor was localized in the thyroid gland, and the maximum diameter of each lesion was less than 4cm;\n  4. ultrasonography of cervical VI lymph nodes: the shortest diameter \\\u003C 4 mm, no calcification, no cystic change, no local or global echo enhancement;\n  5. CT scan of cervical VI lymph nodes: the shortest diameter \\\u003C 4 mm, no calcification, no cystic change, no enhancement (CT value 40HU or not higher than banded muscle level), no cluster distribution;\n  6. patients will voluntarily enter the study after informed consent;\n\nPhase III:\n\n1. aged from 18 to 80 years old;\n2. ultrasound showed that the tumor was localized in the thyroid gland, and the maximum diameter of each lesion was less than 4cm;\n3. Unilateral or bilateral PTC without lymph node metastasis assessed by \"cNo-pN+ PTC prediction model\";\n4. patients will voluntarily enter the study after informed consent.\n\nExclusion Criteria:\n\n* (1) patients refused to participate in the study; (2) non first operation patients; (3) Lateral cervical lymph nodes or distant metastasis; (4) Hashimoto's disease; (5) history of neck trauma.",{"count":364,"type":21},6000,[60],"This study is divided into three stages. In the first stage, the investigators try to explore the objective clinical imaging standard of cN0PTC on the basis of previous studies, formulate the \"clinical imaging standard of cN0PTC\", and randomly enroll 2000 patients under the premise of meeting the standard to establish the \"predictive model of cN0-pN+PTC\".\n\nIn the second stage, 2000 patients will be enrolled to test and improve the evaluation efficiency of \"cN0-pN+PTC prediction model\".\n\nIn the third stage, 2 000 patients without lymph node metastasis assessed by \"cNo-pN+ PTC prediction model\" will be randomly divided into experimental group and control group. The experimental group will be treated with pCND, while the experimental group will be treated without pCND. The central lymph node metastasis probability, the number and size of metastatic lymph nodes in the control group will be observed after operation. The two groups will be followed up for 5, 10, 15 and 20 years to observe the RFS and OS, so as to further evaluate the \"cN0-pN+PTC prediction model\" scientifically.",[29],{"date":349,"type":39},{"date":351,"type":21},{"date":353,"type":21},{"name":355,"class":81}]