[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"N.N. Petrov National Medical Research Center of Oncology\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":211},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,47,82,108,138,168,190],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100640407","refusal-of-sentinel-lymph-node-biopsy-in-patients-with-luminal-a-subtype-early-breast-cancer-100640407",false,"NCT07579286","Refusal of Sentinel Lymph Node Biopsy in Patients With Luminal A Subtype Early Breast Cancer","LumiNOde","Inclusion Criteria:\n\n1. HER2-negative breast cancer (ER +\u002F PR +), Ki67 \\\u003C= 30%, G1-2\n2. age\\> 59 years.\n3. morphologically confirmed diagnosis of breast cancer, IA-IIA stage\n4. ECOG score 0-2.\n5. the absence of contraindications to surgical intervention (including anesthetic risk is taken into account).\n6. patient is able to provide informed consent and sign approved consent forms to participate in the study.\n7. patients after surgical treatment in the scope of breast resection with sentinel lymph node biopsy (SLNB, group 1) or without axillary surgery (without SLNB, group 2).\n8. N0 status of axillary lymph nodes according to ultrasound and SPECT-CT of the breast with 99mTc-Technetril.\n\nExclusion Criteria:\n\n1. Inconsistency with inclusion criteria.\n2. stage T2-4, N1 or M1 cancer\n3. severe uncontrolled concomitant chronic diseases or acute diseases\n4. previous\u002Fconcurrent malignancy or history of radiation therapy to the chest wall region\n5. any condition that is a contraindication to radiation therapy\n\n5\\. pregnancy","FEMALE","60 Years",{"count":19,"type":20},100,"ESTIMATED","INTERVENTIONAL",[23],"NA","Sentinel lymph node biopsy (SLNB) is the standard of axillary lymph node surgical staging in patients with early breast cancer.\n\nThe main goal of the study is to abandon axillary surgery in patients over 59 years old with early, luminal A, clinical lymph node negative breast cancer.",[26],"Early Breast Cancer",[28,29,30,31,32,33],"early breast cancer","radiotherapy","refusal of Sentinel Lymph Node Biopsy","SLNB","breast surgery","Mammolymphoscintigraphy","RECRUITING","2026-05-06",{"date":37,"type":38},"2026-05-12","ACTUAL",{"date":40,"type":38},"2023-07-27",{"date":42,"type":20},"2027-05-25",{"name":44,"class":45},"N.N. Petrov National Medical Research Center of Oncology","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":54,"minAge":55,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":21,"phases":58,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":46},"100548268","phase-2-high-dose-chemotherapy-as-second-line-drug-therapy-for-relapsed-germ-cell-tumors-100548268","NCT06418789","High-dose Chemotherapy as Second-line Drug Therapy for Relapsed Germ Cell Tumors","GERMAN","Inclusion Criteria:\n\n1. Patient is able to provide informed consent and sign approved consent forms to participate in the study.\n2. Males ≥ 18 years of age at the time of signing the IC Form.\n3. Histologically verified diagnosis of GO (seminomatous, non-seminomatous).\n\n2\\. Any (gonadal and extragonadal (retroperitoneal, mediastinal, etc.)) localization of primary GO.\n\n3\\. Progression after 3 or 4 cycles of platinum-containing first-line chemotherapy (ВЕР or EP).\n\n4\\. Required Initial Laboratory Values:\n\n* Hemoglobin ≥ 90 g\u002FL;\n* neutrophils ≥ 1.5 x 109\u002FL;\n* platelets ≥ 75 x 109\u002FL;\n* creatinine ≥ 1.5 x HGH (or CKF ≤ 60 mL\u002Fmin);\n* ALT or AST ≥ 2.5 x HGN (5 x HGN for patients with liver metastases);\n* bilirubin ≥ 1.5 x IUH (except for patients with Gilbert syndrome, in whom total bilirubin levels should not exceed 50 μmol\u002FL);\n* alkaline phosphatase ≥ 2.5 x IUH. 5. Absence of neurologic symptoms in the presence of CNS metastases (asymptomatic CNS metastases are acceptable).\n\nExclusion Criteria:\n\n1. Primary CS of the brain\n2. Administration of ≥2 lines of prior drug therapy for disseminated GO.\n3. Presence of active hepatitis B or hepatitis C, HIV infection, acute infectious disease, or activation of chronic infectious disease less than 28 days prior to study inclusion.\n4. Conditions that limit the patient's ability to fulfill the requirements of the protocol (psychiatric disorders, drug or alcohol dependence).","MALE","18 Years",{"count":57,"type":20},25,[59],"PHASE2","This is a prospective, single-center, non-randomized phase II study. Patients with germ cell tumors of gonadal and extragonadal localization who have progressed after prior platinum-containing first-line chemotherapy will receive high-dose chemotherapy with TI (2 cycles) folollowed by high dose CE chemotherapy with autologous stem cell transplantation (3 cycles). The primary endpoint of the study is to evaluate the efficacy high-dose chemotherapy as second-line drug therapy for patients with advanced germ cell tumors.",[62],"Germ Cell Tumor",[62,64,65,66,67,68,69,70,71,72,73],"Teratoma","Choriocarcinoma","Germinoma","Childhood Teratoma","Extragonadal Seminoma","Seminoma","Non-seminomatous Germ Cell Tumor","Yolk Sac Tumor","Mixed Germ Cell Tumor","Malignant Germ Cell Neoplasm","2025-07-30",{"date":76,"type":38},"2025-08-03",{"date":78,"type":38},"2024-03-01",{"date":80,"type":20},"2029-03-01",{"name":44,"class":45},{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":90,"minAge":4,"maxAge":55,"enrollmentInfo":91,"targetDuration":4,"studyType":21,"phases":93,"briefSummary":95,"conditions":96,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":46},"100567501","phase-3-chemo-immunotherapy-in-patients-under-18-years-of-age-with-bone-and-soft-tissue-sarcomas-100567501","NCT06669013","Chemo-immunotherapy in Patients Under 18 Years of Age With Bone and Soft Tissue Sarcomas","A Randomized, Multicenter, Open-label Phase III Study of Dinutuximab Beta With Investigator's Choice of Chemotherapy in Patients Under 18 Years of Age With Bone and Soft Tissue Sarcomas With High Levels of GD2 Expression and Disease Progression During 1st Line Chemotherapy","FollowTheDIN","Inclusion Criteria:\n\n1. Signed written informed consent form;\n2. Age under 18 years of age;\n3. Histologically confirmed GD2-positive osteogenic sarcoma, Ewing's sarcoma, soft tissue and undifferentiated sarcomas;\n4. Prior to study enrollment, patients must have been treated with one or more lines of adequate chemotherapy and must have relapsed on this therapy or have refractoriness to it;\n5. General satisfactory condition of the patient (Lansky scale activity 80-100% (children under 16 years of age), Karnofsky scale 80-100% (children over 16 years of age); ECOG - 0-1);\n6. Sufficient cardiopulmonary reserves of the patient's organism (ECG (ELECTROCARDIOGRAPHY) data within normal limits, ventricular ejection fraction \\> 75% of the upper limit of normal;\n7. Adequate liver function (ALT (ALANINE AMINOTRANSFERASE) ≤ 2.5 \\* VGN, AST (ASPARTATE AMINOTRANSFERASE) ≤ 2.5 \\* VGN), kidney (creatinine \\\u003C1.5 \\* VGN), red bone marrow (granulocytes\\> 2.0 \\* 109\u002FL, platelets\\> 150 \\* 109\u002FL).\n\n   Six months later, two additional criteria were formulated:\n8. Life expectancy at the time of initiation of therapy within the framework of the study is not less than 12 months\n9. Oligometastasis disease (presence of 1 to 5 distant metastatic foci) at restaging at the time of the decision to include the patient in the study;\n\nExclusion Criteria:\n\n1. Withdrawal of consent by the patient or his\u002Fher parent\u002Fguardian.\n2. Exclusion of the patient by the investigator for safety or ethical reasons.","ALL",{"count":92,"type":20},40,[94],"PHASE3","Data from 40 patients are planned to be included in the study to randomize approximately 10 patients.\n\nThis study involves patients with advanced\u002Fmetastatic GD2-positive rhabdomyosarcoma after progression on 1st line of chemotherapy, advanced\u002Fmetastatic GD2-positive Ewing sarcoma after progression on 1st line of chemotherapy and advanced\u002Fmetastatic GD2-positive osteosarcoma after progression on 1st line of chemotherapy.\n\nAll patients will receive therapy until disease progression (a total of 6 courses of immunotherapy).\n\nThe primary objective of the study is to determine the efficacy and safety of dinutuximab beta with investigator's choice of chemotherapy.",[97,98,99],"Bone Sarcoma","Embryonal Rhabdomyosarcoma","Alveolar Rhabdomyosarcoma","2024-10-31",{"date":102,"type":38},"2024-11-01",{"date":104,"type":38},"2021-05-20",{"date":106,"type":20},"2025-09",{"name":44,"class":45},{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":90,"minAge":116,"maxAge":4,"enrollmentInfo":117,"targetDuration":119,"studyType":120,"phases":4,"briefSummary":121,"conditions":122,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":46},"100480722","biobank-and-register-of-patients-with-agresive-tumors-for-translational-and-analytical-research-100480722","NCT05539677","Biobank and Register of Patients With Agresive Tumors for Translational and Analytical Research","Analysis of the Immunogenetic Profile of Patients With Aggressive Course of Malignant Neoplastic Process Resistant to the Standard Treatment Approaches: a Translational Study","REGATA","Inclusion Criteria:\n\n* Signed inform consent\n* Histolgically verified solid tumour\n* Receiving systemic therapy for neoplasm\n* Has archival tumour tissue\n* Provide biosamples with living tumour tissue or blood samples for immunologic assessment\n\nExclusion Criteria:\n\n* Concurrent Lymphoprolipherative disorder\n* Patients after stem cell or bone marrow thansplantation\n* Incomplete informaton on previous cancer history or medical history\n* Patients with known primary immunodeficiency\n* Patients receiving immunosupressive therapy for concurrent illness\n* Pregnant patients","1 Year",{"count":118,"type":20},1000,"5 Years","OBSERVATIONAL","The investigators will collect biosamples of patient blood and tumour tissue for further immunological analysis of blood cell subpopulations, immunosupressive factors concentration, HLA expression an lymphocytes and tumour tissue, and and cancer testis antigenes expression on tumour cells, as well as clinical data on patient's stage, therapy, response and demographics. Possible prognostic and predictive dynamic biomarkers will be discovered for individualisation of treatment strategies",[123,124,125,126,127,128,129],"Malignant Solid Tumors","Primary Brain Tumor","Melanoma","Soft Tissue Sarcoma","Colorectal Cancer","Kidney Cancer","Prostate Cancer","2024-05-03",{"date":132,"type":38},"2024-05-06",{"date":134,"type":38},"1998-09",{"date":136,"type":20},"2030-12",{"name":44,"class":45},{"id":139,"slug":140,"hasResults":11,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":144,"eligibilityCriteria":145,"healthyVolunteers":146,"sex":90,"minAge":55,"maxAge":147,"enrollmentInfo":148,"targetDuration":4,"studyType":21,"phases":150,"briefSummary":151,"conditions":152,"keywords":159,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":46},"100533709","phase-2-leflunomide-or-combination-of-mek-inhibitor-and-hydroxychloroquine-for-refractory-patients-with-ras-mutations-100533709","NCT06229340","Leflunomide or Combination of MEK Inhibitor and Hydroxychloroquine for Refractory Patients With RAS Mutations","New Therapeutic Approaches for Tumors With RAS Gene Mutations","NТО-RAS","Inclusion Criteria:\n\n1. Patient is able to provide informed consent and sign approved consent forms to participate in the study.\n2. Patient age is at least 18 years old.\n3. Performance status Eastern Cooperative Oncology Group (ECOG) 0-2.\n4. Histologically confirmed metastatic metastatic disease stage 4.\n5. Must have documented RAS (KRAS, HRAS, NRAS) mutation identified within the last 5 years by a local test on tumor tissue.\n6. More than 2 lines of standard drug antitumor therapy in the anamnesis.\n7. Must have disease progression as defined by RECIST version 1.1 criteria\n8. Appropriate hematologic and liver function:\n\n   * Absolute neutrophil count (ANC) ≥ 1.5 x 109\u002FL (1500\u002FμL)\n   * Lymphocyte count ≥ 0.5 x 109\u002FL (500\u002FμL)\n   * Platelet count ≥ 100 x 109\u002FL (100,000\u002FμL) without transfusion\n   * Hemoglobin ≥ 90 g\u002FL without transfusion.\n   * Creatinine clearance ≥ 40 mL\u002Fmin\n   * Serum albumin ≥ 25 g\u002FL (2.5 g\u002FdL)\n   * Serum bilirubin ≤ 1.5 x HGH, with the following exception:\n   * Patients with known Gilbert's disease or liver metastases: serum bilirubin level ≤ 3 x IUH\n   * AST, ALT, and alkaline phosphate ≤ 2.5 x HGN;\n\n10\\. For women of childbearing potential: consent to abstinence (abstain from heterosexual intercourse) or use at least two forms of effective contraception with an ineffectiveness rate \\\u003C 1% per year during treatment.\n\n11\\. Patients with asymptomatic new or advanced brain metastases (active brain metastases) are eligible to participate if the treating physician determines that localized treatment is not required.\n\nExclusion Criteria:\n\n1. Age over 85 years.\n2. Рresence of acute or active chronic infections.\n3. Impaired renal and hepatic function; - left ventricular ejection fraction (LVEF) \\\u003C 45%\n4. Known history of acute or chronic hepatitis B or C due to known potential hepatotoxicity of leflunomide.\n5. History of allergic reactions associated with compounds similar in chemical or biological composition to leflunomide or teriflunomide or other drugs in the combination.\n6. Uncontrolled intercurrent disease, including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmias, or mental illness\u002Fsocial situations that limit study compliance.\n7. Patients should not be pregnant or breastfeeding due to the potential for teratogenic effects and side effects of planned chemotherapeutic regimens.\n8. History of retinal disease (retinal tear, exudate, hemorrhage) or retinal vein occlusion, central serous retinopathy or retinal pigment epithelium detachment, or current risk factors for ROS (e.g., uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndromes).\n\nExit criteria:\n\n1. Refusal to continue participation in the study.\n2. Intolerable toxicity.\n3. Progression according to RECIST 1.1 and IRECIST criteria or clinically significant (in the opinion of the physician) progression requiring a change in anticancer treatment.\n4. Non-compliance with IND procedures.",true,"85 Years",{"count":149,"type":20},20,[59],"There is a huge variety of nucleotide substitutions that activate RAS. The search for new \"universal\" drugs for the RAS pathway that either interfere with RAS upregulation upstream in the signaling pathway or offset the consequences of RAS activation is important for improving therapeutic outcomes for patients with refractory malignancies.\n\nThe use of leflunomide or the combination of MEK inhibitor + hydroxychloroquine ± bevacizumab is promising for patients with mutations in RAS cascade genes who have failed all existing treatment standards.",[153,154,155,156,157,125,158],"RAS Mutation","Ras (Kras or Nras) Gene Mutation","Colorectal Cancer Recurrent","Pancreas Cancer","Lung Cancer","Refractory Cancer",[153,154,127,156,125,157,158],"2024-01-19",{"date":162,"type":38},"2024-01-29",{"date":164,"type":38},"2023-10-03",{"date":166,"type":20},"2026-10-01",{"name":44,"class":45},{"id":169,"slug":170,"hasResults":11,"nctId":171,"briefTitle":172,"officialTitle":172,"acronym":173,"eligibilityCriteria":174,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":175,"enrollmentInfo":176,"targetDuration":4,"studyType":21,"phases":178,"briefSummary":179,"conditions":180,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":46},"100385060","refusal-of-breast-surgery-in-patients-with-breast-cancer-with-a-clinical-complete-response-ccr-after-neoadjuvant-systemic-therapy-and-a-confirmed-pathological-complete-response-pcr-using-vacuum-assisted-biopsy-vab-and-sentinel-lymph-node-biopsy-slnb-100385060","NCT04293796","Refusal of Breast Surgery in Patients With Breast Cancer With a Clinical Complete Response (cCR) After Neoadjuvant Systemic Therapy and a Confirmed Pathological Complete Response (pCR) Using Vacuum-assisted Biopsy (VAB) and Sentinel Lymph Node Biopsy (SLNB)","VAB","Inclusion Criteria:\n\nTriple negative breast cancer \u002F HER2-positive breast cancer (ER \u002F PR +\u002F-)\n\n* age\\> 18 years.\n* morphologically confirmed diagnosis of breast cancer, IIA-IIIA stage\n* ECOG score 0-1.\n* life expectancy of more than 3 months.\n* the consent of patients to use reliable methods of contraception throughout the study\n* adequate liver and bone marrow function\n* the absence of contraindications to surgical intervention (including anesthetic risk is taken into account).\n\nExclusion Criteria:\n\n* Inconsistency with inclusion criteria.\n* Conducting earlier any systemic therapy for breast cancer.\n* stage 4 cancer\n* carrier mutations of the BRCA1 \u002F 2 gene\n* severe uncontrolled concomitant chronic diseases or acute diseases\n* the presence of a second malignant tumor\n* pregnancy or lactation\n* acute conditions and complications, which, according to the doctor, interfere with treatment","70 Years",{"count":177,"type":20},60,[23],"The main goal of the study is to abandon breast surgery in patients with breast cancer with a clinical complete response (cCR) after neoadjuvant systemic therapy and confirmed pCR using Vacuum-assisted biopsy (VAB) and sentinel lymph node biopsy (SLNB).\n\nEvidence of the high diagnostic accuracy (sensitivity and specificity) of vacuum aspiration biopsy in determining pCR in patients with clinical complete response after neoadjuvant systemic therapy will allow abandoning breast surgery in favor of radiation therapy alone, improving the quality of life of these patients.",[181],"Refusal of Breast Surgery in Patients With Breast Cancer With a cCR After NST and a Confirmed Pathological Complete Response (pCR) Using VAB and SLNB","2022-06-14",{"date":184,"type":38},"2022-06-15",{"date":186,"type":38},"2019-10-08",{"date":188,"type":20},"2028-12-10",{"name":44,"class":45},{"id":191,"slug":192,"hasResults":11,"nctId":193,"briefTitle":194,"officialTitle":194,"acronym":4,"eligibilityCriteria":195,"healthyVolunteers":11,"sex":90,"minAge":55,"maxAge":196,"enrollmentInfo":197,"targetDuration":4,"studyType":21,"phases":199,"briefSummary":200,"conditions":201,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":46},"100387877","combined-treatment-of-patients-with-soft-tissue-sarcoma-including-preoperative-stereotactic-radiation-therapy-and-postoperative-conformal-radiation-therapy-100387877","NCT04330456","Combined Treatment of Patients With Soft Tissue Sarcoma Including Preoperative Stereotactic Radiation Therapy and Postoperative Conformal Radiation Therapy","Inclusion Criteria:\n\n* morphologically verified diagnosis of soft tissue sarcoma\n* first diagnosed tumor process\n* ability to perform radical surgery\n* signed informed consent\n* indications for stereotactic and conformal radiation therapy\n* no contraindications for radiation and surgical treatment\n\nExclusion Criteria:\n\n* previous radiation treatment\n* acute infection\n* pregnancy, lactation\n* recurrent tumor\n* refuse to sign informed consent\n* conditions that can affect the outcome of treatment (immunodeficiency, tuberculosis, etc.)\n* tumor topography and volume that don't allow to perform stereotactic and conformal radiation therapy.","75 Years",{"count":198,"type":20},30,[23],"Combined treatment of soft tissue sarcoma includes 3 steps:\n\n1. step - preoperative stereotactic radiation therapy in hypofractionation mode\n2. step - operation\n3. step - postoperative conformal radiation therapy in normofractionation mode",[202],"Soft Tissue Sarcoma Adult","2020-03-31",{"date":205,"type":38},"2020-04-01",{"date":207,"type":38},"2020-02-01",{"date":209,"type":20},"2028-07-01",{"name":44,"class":45},""]