[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"anal-canal-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:anal-canal-cancer":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,53,77,106],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100565292","phase-2-dynamic-ctdna-assessment-in-cervical-and-anal-canal-tumors-optimizing-follow-up-and-clinical-outcomes-100565292",false,"NCT06640283","Dynamic ctDNA Assessment in Cervical and Anal Canal Tumors: Optimizing Follow-up and Clinical Outcomes","Dynamic Assessment of ctDNA in Patients With Cervical and Anal Canal Tumors to Optimize Follow-up and Clinical Outcomes in the Brazilian Unified Health System (SUS)","ANA","Inclusion Criteria:\n\n1. Histological diagnosis of anal canal or cervical cancer.\n2. Documented presence of HPV.\n3. Locally confined or locally advanced disease, defined as:\n\n   1. Anal canal carcinoma stage I to III, according to American Joint Committee on Cancer (AJCC) 8th edition;\n   2. Cervical carcinoma stage I B2 to IV A, according to AJCC 8th edition.\n4. Indication for definitive treatment with radiotherapy, with or without concomitant chemotherapy.\n5. Eastern Cooperative Oncology Group (ECOG)-Performance Status (PS) 0 - 1.\n6. Age ≥ 18 years.\n7. Signing of the Informed Consent Form (ICF).\n8. HIV-positive patients may be included if Cluster of Differentiation 4(CD4) count is greater than or equal to 200.\n9. Patients may participate in other concurrent studies, as long as they do not involve interventions related to the treatment of the underlying cancer.\n\nExclusion Criteria:\n\n1. Patients with unequivocal distant metastasis at diagnosis.\n2. For participants with positive ctDNA after treatment, those candidates for participation in Phase II will be excluded if there is unequivocal radiological progression in the first imaging exam after the completion of radiotherapy (with or without chemotherapy) or routine indication for salvage surgery immediately after the conclusion of definitive treatment.\n3. Need for recurrent blood transfusions, such as weekly frequency.\n4. Another uncontrolled disease representing a life risk, as determined by medical judgment.\n5. Personal history of another active invasive malignant neoplasm in the last 5 years, except for non-melanoma skin carcinomas and in situ carcinomas.\n6. Pregnant individuals.\n7. Active opportunistic infection or disease.\n8. History of autoimmune diseases.","ALL","18 Years",{"count":20,"type":21},150,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","After definitive radiotherapy (RT) treatment (with or without chemotherapy), cervical and anal canal neoplasms frequently exhibit disease persistence or recurrence. Due to the local inflammatory process post-treatment, response assessment by imaging (current gold standard) is limited, often necessitating multiple follow-ups and repeated invasive biopsies. Conventional follow-up is complex and costly, requiring equipment from secondary and tertiary services, trained radiologists, and patient exposure to radiation and contrast.\n\nIn this context of human papillomavirus(HPV)-related neoplasms, recent studies have demonstrated the role of ctDNA (circulating tumor DNA) in assessing the risk of recurrence or disease progression, providing a rationale for using the tool in two fronts:\n\n* Optimizing follow-up based on serial monitoring of ctDNA;\n* Selecting patients with positive ctDNA after RT, who are at high risk of recurrence, for treatment intensification.\n\nMonitoring with ctDNA as a standalone follow-up tool in cases evolving with negative ctDNA after RT has the potential to replace imaging exams, being a minimally invasive test performed on a peripheral blood sample. Currently, ctDNA testing has expensive methodologies not available in the Unified Health System (SUS). This project aims to develop a methodology for ctDNA evaluation focused on HPV ctDNA research that is low-cost and executable in SUS, as well to assess the accuracy of this test in the population with HPV-related tumors.\n\nAdditionally, we will evaluate whether the early introduction of immunotherapy in patients with positive ctDNA after definitive treatment can increase cure rates. Immunotherapy already has a well-defined role in the treatment of metastatic HPV-related neoplasms. Recently, the use of anti-programmed death-1 (anti-PD1) has also shown benefits in patients with locally advanced cervical cancer with a high risk of recurrence who are candidates for chemoradiotherapy (CRT). Therefore, its use focused on HPV-related tumors, as well as a better understanding of which patients benefit from this strategy, warrants further investigation.",[27,28,29,30,31],"HPV-Related Carcinoma","Uterine Cervical Cancer","Anal Canal Cancer","HPV-Related Anal Squamous Cell Carcinoma","HPV-Related Cervical Carcinoma",[33,34,35,36,37,38,39],"HPV","ctDNA","Cervical tumors","Anal canal tumors","Molecular diagnosis","Diagnostic test","Biomarkers","RECRUITING","2025-12-18",{"date":43,"type":44},"2025-12-24","ACTUAL",{"date":46,"type":44},"2025-03-14",{"date":48,"type":21},"2027-01",{"name":50,"class":51},"Instituto do Cancer do Estado de São Paulo","OTHER",1,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":61,"targetDuration":4,"studyType":22,"phases":63,"briefSummary":64,"conditions":65,"keywords":66,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":52},"100442394","phase-2-inguinal-node-sparing-radiotherapy-for-patients-with-early-stage-anal-cancer-100442394","NCT05040815","Inguinal Node Sparing Radiotherapy For Patients With Early Stage Anal Cancer","A Prospective Phase II Study of Inguinal Node Sparing Radiotherapy For Patients With Early Stage Anal Cancer (INSPIRE)","INSPIRE","Inclusion Criteria:\n\n1. Participants capable of giving informed consent.\n2. Patients must be 18 years of age or older.\n3. Patient should have histologically proven primary squamous cell carcinoma.\n4. Patients must have early AC, Stage T1-3 N0 M0.\n5. No inguinal nodal involvement confirmed by PET imaging and SLNB.\n6. No history of prior malignancy other than non-melanoma skin cancer or other malignancy with disease free survival ≥ 5 years.\n7. Performance status ECOG 0-2 \u002F Zubrod performance status ≥70.\n8. Patient should be eligible for concomitant chemotherapy (e.g. adequate hepatic, renal and bone marrow function).\n9. Women of child bearing potential (WOCBP) must have a negative serum (or urine) pregnancy test at the time of screening. WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy or bilateral salpingectomy) and is not postmenopausal. Menopause is defined as 12 months of amenorrhea in a woman over age 45 years in the absence of other biological or physiological causes. In addition, females under the age of 55 years must have a serum follicle stimulating hormone, (FSH) level \\> 40 mIU\u002FmL to confirm menopause.\n10. Patients of childbearing \u002F reproductive potential should use highly effective birth control methods, as defined by the investigator, during the study treatment period. A highly effective method of birth control is defined as those that result in low failure rate (i.e. less than 1% per year) when used consistently and correctly (Note: abstinence is acceptable if this is established and preferred contraception for the patient and is accepted as a local standard).\n11. Females must not breastfeed during study treatment.\n12. Male patients should agree to not donate sperm during study treatment.\n13. Absence of any condition hampering compliance with study protocols and follow-up schedule; those conditions should be reviewed with the patient prior to trial registration.\n\nExclusion Criteria:\n\n1. T1N0 patients going for primary surgery\n2. Prior radiation therapy to the pelvis.\n3. Pregnancy or lactation.\n4. Prior surgical treatment for anal cancer other than biopsy.\n5. Prior surgical or chemotherapy treatment for anal cancer.\n6. Evidence of distant metastases.\n7. Comorbid medical conditions precluding radical treatment at the discretion of Oncologist.\n8. Histology other than squamous cell carcinoma or variants.",{"count":62,"type":21},45,[24],"The purpose of this study is to see whether avoiding preventative radiation to the groin in patients with normal sentinel node biopsy and PET-CT, is at least as effective treating cancer as giving preventative radiation to the groin for patients with anal canal cancer.\n\nThe investigators also want to know if avoiding radiation to the groin will cause fewer side effects and better quality of life",[29],[67],"radiotherapy","2025-10-01",{"date":70,"type":44},"2025-10-02",{"date":72,"type":44},"2023-05-11",{"date":74,"type":21},"2028-05",{"name":76,"class":51},"AHS Cancer Control Alberta",{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":84,"minAge":85,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":22,"phases":88,"briefSummary":90,"conditions":91,"keywords":92,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":52},"100597511","screening-for-anal-cancer-and-precancer-in-women-with-hiv-sanca-100597511","NCT07059442","Screening for Anal Cancer and Precancer in Women With HIV (SANCA)","SANCA","Inclusion Criteria:\n\n* Women (biological sex) with HIV\n* 45 years old or older\n* attending the out-patient HIV departments at Karolinska University Hospital in Stockholm, the South Hospital in Stockholm, and Sahlgrenska University Hospital in Gothenburg\n\nExclusion Criteria:\n\n* Women who have had anal cancer\n* women who have had rectal amputation","FEMALE","45 Years",{"count":87,"type":21},1000,[89],"NA","The main aim of the SANCA study is to evaluate the feasibility, cost-effectiveness, and acceptability of implementing international anal cancer screening guidelines for women living with HIV in Sweden, integrating health economic and patient-centered approaches.\n\nSecondly the investigators wish to investigate the predictive potential of DNA methylation markers for the clinical progression of precancerous anal lesions in women with HIV, combining prospective molecular biology analysis with clinical data from registries.",[29],[93,94,95],"HIV","Human papilloma virus","DNA methylation","NOT_YET_RECRUITING","2025-07-09",{"date":99,"type":44},"2025-07-10",{"date":101,"type":21},"2025-09-01",{"date":103,"type":21},"2035-12-31",{"name":105,"class":51},"Karolinska Institutet",{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":22,"phases":115,"briefSummary":116,"conditions":117,"keywords":121,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":52},"100223376","phase-2-stereotactic-body-radiation-therapy-sbrt-for-unresectable-liver-metastases-100223376","NCT02185443","Stereotactic Body Radiation Therapy (SBRT) for Unresectable Liver Metastases","Stereotactic Body Radiation Therapy for the Treatment of Unresectable Liver Metastases in Patients With Colorectal Adenocarcinoma, Carcinoma of the Anal Canal and Gastrointestinal Neuroendocrine Tumors","Inclusion Criteria:\n\n* Karnofsky Performance Scale (KPS) equal or greater than 70\n* 1 to 4 liver metastases with an individual maximum diameter of up to 5 cm\n* Lesions considered unresectable or patients considered unfit for surgery\n* Histology of the primary tumor: colorectal adenocarcinoma, carcinoma of the anal canal or gastrointestinal neuroendocrine tumors.\n* Absence of evidence of extra-hepatic disease or extra-hepatic disease to be treated with curative intent.\n* Minimum interval of 2 weeks between systemic chemotherapy and SBRT.\n* Adequate bone marrow function defined as:\n* absolute neutrophils count \\> 1,800 cells \u002F mm 3\n* platelets \\> 100,000 cells \u002F mm 3\n* hemoglobin \\> 8.0 g \u002F dl ( transfusion or other intervention accepted)\n\nExclusion Criteria:\n\n* Concomitant chemotherapy\n* Prior radiotherapy to the upper abdomen\n* Pregnancy\n* Underlying Cirrhosis\n* Active hepatitis or clinically significant liver failure\n* Prior invasive neoplasm except for non-melanoma skin cancer, or unless more than five years without evidence of disease\n* Severe Comorbidity\n* Current anticoagulant treatment",{"count":114,"type":21},43,[24],"This is a Phase II study to determine the efficacy of SBRT to treat liver metastases in patients with Colorectal Adenocarcinoma, Carcinoma of the Anal Canal and Gastrointestinal Neuroendocrine Tumors that are not amenable to surgery. Patients should have no evidence of extra-hepatic disease or have disease that is planned to be treated with curative intent.\n\nTherefore, SBRT is being considered as a potentially curative procedure.",[118,119,29,120],"Liver Metastases","Colorectal Cancer","Gastrointestinal Neuroendocrine Tumors",[122,123,124,125,126,127],"SBRT","radiation","Neoplasm Metastasis","Colorectal Neoplasms","Anal Canal","Neuroendocrine Tumors","2024-12-04",{"date":130,"type":44},"2024-12-09",{"date":132,"type":4},"2014-05",{"date":134,"type":21},"2026-12",{"name":136,"class":51},"University of Sao Paulo"]