[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hpv-related-anal-squamous-cell-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hpv-related-anal-squamous-cell-carcinoma":43},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,85,122,146,177,207,234],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":47,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":84},"100491983","phase-2-e7-tcr-t-cell-immunotherapy-for-human-papillomavirus-hpv-associated-cancers-100491983",false,"NCT05686226","E7 TCR-T Cell Immunotherapy for Human Papillomavirus (HPV) Associated Cancers","A Phase II Trial of T Cell Receptor Gene Therapy Targeting Human Papillomavirus ( HPV) 16 E7 for HPV-Associated Cancers","Inclusion Criteria: Subjects must meet all the following criteria to participate in this study.\n\n1. Histologically or cytologically confirmed metastatic or refractory\u002Frecurrent HPV-16+ cancer.\n2. Tumor and\u002For blood with HPV16 genotype as determined by testing performed in a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory.\n3. HLA-A\\*02:01 allele as determined by testing performed in a CLIA certified laboratory. Participants may be enrolled based on low resolution typing (i.e., HLA-A\\*02) but the HLA-A\\*02:01 allele type must be confirmed prior to apheresis.\n4. Measurable disease as assessed by RECIST Criteria Version 1.1.\n5. Age ≥ 18 years.\n6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 at screening.\n7. Must have received prior first line standard therapy or have declined standard therapy.\n8. Standard treatment options for first and second-line therapy must be presented and formally declined (Appendix VII).\n9. Patients with three or fewer brain metastases that have been treated with surgery or stereotactic radiosurgery are eligible. Lesions that have been treated with stereotactic radiosurgery must be clinically stable for one month before protocol treatment. Patients must be fully recovered from surgery.\n10. Negative pregnancy test for women under 55 and all women who have had a menstrual period in the last 12 months. A pregnancy test is not required for women who have had a bilateral oophorectomy or hysterectomy.\n11. Men and women of child-bearing potential must agree to use adequate contraception (i.e., intrauterine device, hormonal barrier method of birth control, abstinence, tubal ligation, or vasectomy) prior to study entry and for four months after treatment. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately.\n12. Seronegative for HIV antibody, hepatitis B antigen (HBsAg), and hepatitis C antibody. If a hepatitis C antibody test is positive, then testing for antigen by RT-PCR for hepatitis C (HCV) RNA must be negative.\n13. Participants must have organ and marrow function as defined below:\n\n    1. Leukocytes \\> 3,000\u002FmcL\n    2. Absolute neutrophil count \\> 1,500\u002FmcL\n    3. Platelets \\> 100,000\u002FmcL\n    4. Hemoglobin \\> 9.0 g\u002FdL\n    5. Total bilirubin within normal institutional limits except in participants with Gilbert's Syndrome who must have a total bilirubin \\\u003C 3.0 mg\u002FdL.\n    6. Serum aspartate transferase (AST) (SGOT)\u002Falanine transaminase (ALT) (SGPT) \\\u003C 2.5 x upper limit of normal (ULN)\n    7. Calculated creatinine clearance (CrCl) \\>50 mL\u002Fmin\u002F1.73 m2 for participants with creatinine levels above institutional normal (by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation).\n    8. International normalized ratio (INR) or activated partial thromboplastin time (aPTT) ≤1.5 X ULN unless the subject is receiving anticoagulant therapy. Subjects on anticoagulant therapy must have a PT or aPTT within therapeutic range and no history of severe hemorrhage.\n14. More than four weeks must have elapsed since any prior systemic therapy at the time the patient receives the E7 TCR cells. Adverse events from prior therapy must have resolved to ≤ grade 1 according to CTCAE Version 5.0 or have demonstrated clinical stability for the protocol.\n15. Participants must be able to understand and be willing to sign the written informed consent document.\n16. Participants must agree to participate in Rutgers protocol 192103 (Pro2021002307) for gene therapy long term follow up and in Rutgers protocol 192002 (Pro2021000281) or NIH protocol 16C0061 (Rutgers 192202) for biospecimen collection study.\n\nNote: Participants may have undergone minor surgical procedures with the past three weeks, as long as all toxicities have recovered to Grade 1 or less.\n\nExclusion Criteria: Subjects who meet any of the following criteria will be excluded from participation in this study:\n\n1. Uncontrolled intercurrent illness such as active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations at the time of treatment that would limit compliance with study requirements.\n2. History of severe allergic reactions to compounds of similar chemical or biological composition to agents used in this study.\n3. History of coronary revascularization or ischemic symptoms unless patient has a normal cardiac stress test.\n4. Documented LVEF of less than or equal to 45% tested. The following participants will undergo cardiac evaluations:\n\n   1. Clinically significant atrial and\u002For ventricular arrhythmias including but not limited to: atrial fibrillation, ventricular tachycardia, second or third degree heart block or\n   2. Age ≥ 50 years old\n5. Participants with baseline screening pulse oxygen level of ≤ 92% on room air will not be eligible. If the underlying cause of hypoxia improves, then they may be reevaluated.\n6. Subjects with HLA-A\\*02:01 damaging mutation or allele loss detected by clinical or research genomic profiling will not be eligible.\n7. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with E7 TCR T cells, breastfeeding should be discontinued if the mother is treated with E7 TCR T cells. These potential risks may also apply to other agents used in this study.\n8. Participants with a systemic immunodeficiency including acquired deficiency such as HIV or primary immunodeficiency such as Severe Combined Immunodeficiency Disease are ineligible. The experimental treatment being evaluated in this protocol depends on an intact immune system. Participants who have decreased immune competence may be less responsive to the treatment.\n9. Participants on immunosuppressive drugs including corticosteroids unless meeting criteria outlined in Section 6.1 (Prohibited Medications).\n10. Participants with potentially severe autoimmune diseases such as Crohn's disease, ulcerative colitis, rheumatoid arthritis, autoimmune hepatitis, autoimmune pancreatitis, or systemic lupus erythematosus are not eligible. Patients with less severe autoimmune diseases such as hypothyroidism, vitiligo, and other minor autoimmune disorders are eligible.\n11. Participants with prior or concurrent malignancy whose natural history or treatment is unlikely to interfere with the safety or efficacy assessments of the investigational regimen are eligible for this trial. Examples include, but are not limited to:\n\n    1. Carcinoma in situ\n    2. Cutaneous skin cancers requiring only local excision\n    3. Low grade non-muscle invasive bladder cancer\n    4. Low grade prostate cancer\n\n    Participants with prior or concurrent malignancy that do not meet the above criteria are excluded.\n12. Subjects who received a live vaccine within 30 days prior to enrollment are not eligible.\n13. Determination by the Principal Investigator that participation is not in the best interest of the research subject or may jeopardize the safety of the subject or integrity of the clinical trial data.\n14. Current treatment with another investigational agent.","ALL","18 Years",{"count":19,"type":20},20,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This is a phase II clinical trial to assess the clinical activity of immunotherapy with E7 TCR-T cells for metastatic HPV-associated cancers. HPV-associated cancers in include cervical, throat, penile, vulvar, vaginal, anal, and other cancers. Participants will receive a conditioning regimen, E7 TCR-T cells, and aldesleukin. Clinical response to treatment will be determined.",[26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46],"Cervical Cancer","Throat Cancer","Oropharynx Cancer","Anal Cancer","Vulva Cancer","Vaginal Cancer","Penile Cancer","Metastatic Cancer","HPV-Related Malignancy","HPV-Related Carcinoma","HPV-Related Cervical Carcinoma","HPV-Related Squamous Cell Carcinoma","HPV-Related Adenocarcinoma","HPV Positive Oropharyngeal Squamous Cell Carcinoma","HPV-Associated Vaginal Adenocarcinoma","HPV-Related Adenosquamous Carcinoma","HPV-Related Endocervical Adenocarcinoma","HPV-Related Anal Squamous Cell Carcinoma","HPV-Related Penile Squamous Cell Carcinoma","HPV-Related Vulvar Squamous Cell Carcinoma","HPV Positive Rectal Squamous Cell Carcinoma",[48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71],"Chimeric antigen receptors (CAR-T)","Tumor infiltrating lymphocyte","TCR-T","immunotherapy","T cell","adoptive cell therapy","cellular therapy","gene therapy","human papillomavirus","HPV","E7","T cell receptor","TCR","E7 TCR","lymphocyte","cell therapy","cervical cancer","oropharyngeal cancer","anal cancer","vulvar cancer","vaginal cancer","penile cancer","tumor infiltrating lymphocytes (TIL)","TIL therapy","RECRUITING","2026-06-10",{"date":75,"type":76},"2026-06-12","ACTUAL",{"date":78,"type":76},"2023-03-07",{"date":80,"type":20},"2027-01-01",{"name":82,"class":83},"Christian Hinrichs","OTHER",3,{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":21,"phases":94,"briefSummary":96,"conditions":97,"keywords":100,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":115,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},"100488427","phase-1-e7-t-cell-receptor-tcr--t-cell-induction-therapy-for-locoregionally-advanced-hpv-associated-cancers-100488427","NCT05639972","E7 T-cell Receptor (TCR) -T Cell Induction Therapy for Locoregionally Advanced HPV-associated Cancers","A Feasibility Study of E7 TCR-T Cell Induction Therapy for Locoregionally Advanced HPV-Associated Cancers","Inclusion Criteria: Subjects must meet all the following criteria to participate in this study.\n\n1. Histologically confirmed carcinoma of a primary tumor site and stage indicated in Table 3 of the protocol.\n2. Tumor with HPV16 genotype as determined by testing performed in a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory.\n3. HLA-A\\*02:01 allele determined by testing performed in a CLIA certified laboratory. Participants may be enrolled based on low resolution typing (i.e., HLA-A\\*02) but the HLA-A\\*02:01 allele type must be confirmed prior to apheresis.\n4. Measurable disease per RECIST Criteria Version 1.1 or PERCIST.\n5. Age ≥ 18 years.\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening.\n7. Negative pregnancy test for women under 55 and all women who have had a menstrual period in the last 12 months. A pregnancy test is not required for women who have had a bilateral oophorectomy or hysterectomy.\n8. Men and women of child-bearing potential must agree to use adequate contraception (i.e., intrauterine device, hormonal barrier method of birth control, abstinence, tubal ligation, or vasectomy) prior to study entry and for four months after treatment. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately.\n9. Seronegative for HIV antibody, hepatitis B surface antigen (HBsAg), and hepatitis C antibody. If a hepatitis C antibody test is positive, then testing for antigen by reverse transcription polymerase chain reaction (RT-PCR) must be negative.\n10. Participants must have organ and marrow function as defined below:\n\n    1. Leukocytes \\> 3,000\u002FmcL\n    2. Absolute neutrophil count \\> 1,500\u002FmcL\n    3. Platelets \\> 100,000\u002FmcL\n    4. Hemoglobin \\> 9.0 g\u002FdL\n    5. Total bilirubin within normal institutional limits except in participants with Gilbert's Syndrome who must have a total bilirubin \\\u003C 3.0 mg\u002FdL.\n    6. Serum aspartate aminotransferase (AST) (SGOT)\u002F alanine transaminase (ALT) (SGPT) \\\u003C 2.5 x upper limit of normal (ULN)\n    7. Calculated creatinine clearance (CrCl) \\>50 mL\u002Fmin\u002F1.73 m2 for participants with creatinine levels above institutional normal (by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation).\n    8. International normalized ratio (INR) or activated partial thromboplastin time (aPTT) ≤1.5 X ULN unless the subject is receiving anticoagulant therapy. Subjects on anticoagulant therapy must have a PT or aPTT within therapeutic range and no history of severe hemorrhage.\n11. Participants must be able to understand and be willing to sign the written informed consent document.\n12. Participants must agree to participate in Rutgers protocol 192103 (Pro2021002307) for gene therapy long term follow up and in Rutgers protocol 192002 (Pro2021000281) for biospecimen studies.\n\nNote: Patients may have undergone minor surgical procedures with the past three weeks, as long as all toxicities have recovered to Grade 1 or less.\n\nExclusion Criteria: Subjects who meet any of the following criteria will be excluded from participation in this study:\n\n1. Have received prior systemic therapy or definitive chemoradiation for the cancer that is being treated on this protocol. Palliative radiation therapy for symptom management, such as to control tumor-induced bleeding, is permitted.\n2. Current treatment with another investigational agent.\n3. History of severe allergic reactions to compounds of similar chemical or biological composition to agents used in this study.\n4. Uncontrolled intercurrent illness such as active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations at the time of treatment that would limit compliance with study requirements.\n5. Subjects with HLA-A\\*02:01 damaging mutation or allele loss detected by research or clinical sequencing will not be eligible.\n6. Documented LVEF of less than or equal to 45% tested. The following participants will undergo cardiac evaluations:\n\n   1. Clinically significant atrial and\u002For ventricular arrhythmias including but not limited to: atrial fibrillation, ventricular tachycardia, second or third degree heart block or\n   2. Age ≥ 50 years old\n7. Participants with baseline screening pulse oxygen level of ≤ 92% on room air will not be eligible. If the underlying cause of hypoxia improves, they may be reevaluated.\n8. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with E7 TCR T cells, breastfeeding should be discontinued if the mother is treated with E7 TCR T cells. These potential risks may also apply to other agents used in this study.\n9. Participants with a systemic immunodeficiency including acquired deficiency such as HIV or primary immunodeficiency such as Severe Combined Immunodeficiency Disease are ineligible. The experimental treatment being evaluated in this protocol depends on an intact immune system. Participants who have decreased immune competence may be less responsive to the treatment.\n10. Participants on immunosuppressive drugs including corticosteroids unless meeting criteria outlined in Section 6.1 (Prohibited Medications).\n11. Participants with potentially severe autoimmune diseases such as Crohn's disease, ulcerative colitis, rheumatoid arthritis, autoimmune hepatitis, autoimmune pancreatitis, or systemic lupus erythematosus are not eligible. Patients with less severe autoimmune diseases such as hypothyroidism, vitiligo, and other minor autoimmune disorders are eligible.\n12. Participants with prior or concurrent malignancy whose natural history or treatment is unlikely to interfere with the safety or efficacy assessments of the investigational regimen are eligible for this trial. Examples include, but are not limited to:\n\n    1. Carcinoma in situ\n    2. Cutaneous skin cancers requiring only local excision\n    3. Low grade non-muscle invasive bladder cancer\n    4. Low grade prostate cancer\n13. Subjects who received a live vaccine within 30 days prior to enrollment are not eligible.\n14. Determination by the Principal Investigator that participation is not in the best interest of the research subject or may jeopardize the safety of the subject or integrity of the clinical trial data.",{"count":93,"type":20},15,[95,23],"PHASE1","The goal of this study is to determine the feasibility of administration of a single dose of E7 TCR-T cells as induction therapy prior to definitive treatment (chemoradiation or surgery) of locoregionally advanced HPV-associated cancers. The intent of E7 TCR-T cell treatment is to shrink or eliminate tumors and thereby facilitate definitive therapy and increase overall survival.\n\nThis study seeks to determine 1) if E7 TCR-T cells can be administered without undue delay in definitive treatment, 2) the tumor response rate to E7 TCR-T cell treatment, and 3) the disease-free survival rate at 2 and 5 years.\n\nParticipants will undergo an apheresis procedure to obtain T cells that will be genetically engineered to generate E7 TCR-T cells. They will receive a conditioning regimen, a single infusion of their own E7 TCR-T cells, and adjuvant aldesleukin. Participants will follow up to assess safety and determine tumor response and will return to their primary oncology team for definitive therapy.",[98,35,34,39,38,41,37,43,44,45,42,26,28,29,99,32,31],"HPV-Associated Cervical Carcinoma","Vulvar Cancer",[57,101,102,103,104,105,106,49,60,52,107,108,109,110,111,112,113,114],"Cell therapy","Adoptive cell therapy","Immunotherapy","Radiation","Chemoradiation","CAR-T, cell therapy","Gene therapy","Cervical cancer","Oropharyngeal cancer","Anal cancer","Vulvar cancer","Vaginal cancer","Penile cancer","Induction therapy",{"date":75,"type":76},{"date":117,"type":76},"2025-08-11",{"date":119,"type":20},"2026-10-01",{"name":82,"class":83},2,{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":4,"eligibilityCriteria":128,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":129,"targetDuration":4,"studyType":130,"phases":4,"briefSummary":131,"conditions":132,"keywords":134,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":121},"100428322","detecting-hpv-dna-in-anal-and-cervical-cancers-100428322","NCT04857528","Detecting HPV DNA in Anal and Cervical Cancers","Circulating HPV DNA in Cancers of the Anus and Uterine Cervix Treated With Definitive Radiation Therapy","Inclusion Criteria:\n\n* Stage I-III anal cancer or stage I-IVA cervical cancer that is p16+ based on immunohistochemistry.\n* Age ≥ 18 years\n* Planned to undergo radiation therapy as definitive treatment, with or without concurrent systemic therapy\n\nExclusion Criteria:\n\n* Anal carcinoma not associated with HPV-16, 18, 31, 33, or 35 will be removed from the\n* Planned to undergo radiation therapy as an adjuvant or post-operative therapy",{"count":19,"type":20},"OBSERVATIONAL","This is a research study for individuals who have cancer associated with human papillomavirus (HPV) and are being treated with radiation as part of standard care for their cancer. Doctors leading this study will use blood tests to find out if they can detect the HPV virus in the blood of study participants before, during, and after radiation treatment. They will also collect blood and archival tumor tissue (from a previous biopsy) to perform other tests in the future that could provide more information about HPV-associated cancers and how they respond to treatment. Participation in this study will last approximately 2 years.",[26,29,43,36,35,133],"Uterine Cervical Cancer",[57,135,64,66,136],"radiation treatment","uterine cervix","2026-03-02",{"date":139,"type":76},"2026-03-04",{"date":141,"type":76},"2020-10-06",{"date":143,"type":20},"2027-11-15",{"name":145,"class":83},"University of Chicago",{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":152,"eligibilityCriteria":153,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":154,"targetDuration":4,"studyType":21,"phases":156,"briefSummary":157,"conditions":158,"keywords":160,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":176},"100565292","phase-2-dynamic-ctdna-assessment-in-cervical-and-anal-canal-tumors-optimizing-follow-up-and-clinical-outcomes-100565292","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.",{"count":155,"type":20},150,[23],"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.",[35,133,159,43,36],"Anal Canal Cancer",[57,161,162,163,164,165,166],"ctDNA","Cervical tumors","Anal canal tumors","Molecular diagnosis","Diagnostic test","Biomarkers","2025-12-18",{"date":169,"type":76},"2025-12-24",{"date":171,"type":76},"2025-03-14",{"date":173,"type":20},"2027-01",{"name":175,"class":83},"Instituto do Cancer do Estado de São Paulo",1,{"id":178,"slug":179,"hasResults":11,"nctId":180,"briefTitle":181,"officialTitle":181,"acronym":4,"eligibilityCriteria":182,"healthyVolunteers":183,"sex":16,"minAge":184,"maxAge":185,"enrollmentInfo":186,"targetDuration":4,"studyType":21,"phases":188,"briefSummary":190,"conditions":191,"keywords":193,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":198,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":206},"100564391","screening-strategies-among-high-risk-populations-for-anal-cancer-100564391","NCT06628570","Screening Strategies Among High-risk Populations for Anal Cancer","Inclusion Criteria:\n\n* 30-80 years of age\n* Individuals with chronic impaired immune status\n* History of high-grade lower genital tract neoplasia (LGTN), Zubrod Performance Status of 0-2;\n\nExclusion Criteria:\n\n* Patients treated for aHSIL less than 6 months before screening,\n* History of anal cancer and pregnant women.",true,"30 Years","80 Years",{"count":187,"type":20},500,[189],"NA","The goal of the proposed research is to 1) examine the performance of emerging screening methods for anal high-grade squamous intraepithelial lesion (aHSIL), a precancerous condition of anal cancer, among populations at high risk for anal cancer and 2) characterize DNA methylation, immunologic response, and environmental factors associated with aHSIL.",[192,43],"Neoplasms",[194,195,196],"Cancer","HIV","Screening","2025-09-02",{"date":199,"type":76},"2025-09-08",{"date":201,"type":76},"2024-12-16",{"date":203,"type":20},"2027-10",{"name":205,"class":83},"Lisa Flowers",4,{"id":208,"slug":209,"hasResults":11,"nctId":210,"briefTitle":211,"officialTitle":211,"acronym":212,"eligibilityCriteria":213,"healthyVolunteers":183,"sex":214,"minAge":215,"maxAge":4,"enrollmentInfo":216,"targetDuration":4,"studyType":21,"phases":218,"briefSummary":219,"conditions":220,"keywords":224,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":176},"100290490","screening-for-anal-cancer-in-women-with-high-grade-vulvar-dysplasia-or-vulvar-cancer-100290490","NCT03061435","Screening for Anal Cancer in Women With High-grade Vulvar Dysplasia or Vulvar Cancer.","Vulvar-AIN","Inclusion Criteria:\n\n* Women age ≥ 40\n* Previous diagnosis of VIN 2\u002F3 or vulvar\n\nExclusion Criteria:\n\n* Women with a previous diagnosis of cancer aside from basal cell carcinoma of the skin, cervical cancer, or vulvar cancer\n* Women who are HIV positive\n* Women currently taking immunosuppressant medication\n* Women who have had a previous hysterectomy","FEMALE","40 Years",{"count":217,"type":20},110,[189],"Almost half of all women will develop an HPV infection in their lifetime. While most infections are naturally asymptomatic or cleared by the immune system, some persist and can lead to the development of cervical, vulvar, or anal lesions and eventually cancer. Screening regimens for these lesions are currently only in place for the cervix through regular Pap tests. These Pap tests usually involve an examination of the vulva -however, no screening procedures exist for anal cancer for women. Several studies have suggested that women with existing gynecological lesions are more likely to develop anal lesions and anal cancer. Here the investigators propose a multi-center study which seeks to screen for and treat anal cancer in women over the age of 40 with vulvar lesions and a stable immune system. The investigators will achieve this through performing anal Pap smears on eligible women and conducting High Resolution Anoscopy (HRA) and appropriate treatment procedures on those with abnormal anal cells. With enough evidence, there may be an indication to establish regular anal cancer screening measures in this potentially underserved population.\n\nHypothesis: The investigators hypothesize that at least 40% of women with vulvar cancer or VIN2\u002F3 will have abnormal anal cytology. 35% of the population will be hrHPV DNA positive and 11% will additionally have AIN2\u002F3. This prospective study may lay the groundwork for routine anal screening regimens in Ontario and help shift health policy to treat this population.",[99,26,221,222,29,223,43],"Vulvar Dysplasia","Cervical Dysplasia","Anal Dysplasia",[99,26,221,222,29,223,57],"2025-05-13",{"date":227,"type":76},"2025-05-16",{"date":229,"type":76},"2021-02-01",{"date":231,"type":20},"2026-01-01",{"name":233,"class":83},"Dr. Danielle Vicus",{"id":235,"slug":236,"hasResults":11,"nctId":237,"briefTitle":238,"officialTitle":239,"acronym":4,"eligibilityCriteria":240,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":241,"targetDuration":4,"studyType":21,"phases":243,"briefSummary":244,"conditions":245,"keywords":249,"overallStatus":256,"whyStopped":4,"lastUpdateSubmitDate":257,"lastUpdatePostDateStruct":258,"startDateStruct":260,"completionDateStruct":262,"leadSponsor":264,"locationsCount":4},"100554935","phase-1-phase-12-study-of-autologous-scg142-tcr-t-cells-in-patients-with-hpv1652-positive-carcinoma-100554935","NCT06505551","Phase 1\u002F2 Study of Autologous SCG142 TCR T Cells in Patients With HPV16\u002F52-positive Carcinoma","A Phase 1\u002F2 Open Label, Single Arm, Multicenter Study to Evaluate the Safety and Preliminary Eficacy of Autologous SCG142 T Cell Receptor (TCR) T Cells in Patients With Advanced or Metastatic HPV16- or HPV52-positive Carcinomas","Main Inclusion Criteria:\n\n1. Histologically confirmed squamous cell carcinoma (SCC); may include any of the following tumor types: cervical, head and neck, anal, penile, vulvar, or vaginal.\n2. Tumor tissue positive for HPV16 or HPV52.\n3. Advanced or metastatic carcinoma with progression after at least 1 line of standard of care systemic therapies, including but not limited to combination chemotherapy and\u002For combination chemo-immunotherapy.\n4. Human leukocyte antigen (HLA)-A\\*02:01 genotype.\n5. Measurable disease as defined by RECIST v1.1.\n6. Eastern Cooperative Group (ECOG) Performance Status of 0 or 1.\n7. Anticipated life expectancy ≥3 months.\n8. Adequate laboratory parameters including hematologic, renal, hepatic and coagulation function.\n\nMain Exclusion Criteria:\n\n1. Presence of clinically relevant or active seizure disorder, stroke, cerebrovascular ischemia\u002Fhemorrhage, dementia, cerebellar disease, or any autoimmune disease with central nervous system (CNS) involvement.\n2. Active brain metastasis or leptomeningeal metastases.\n3. History of other malignancy within 2 years prior to Screening.\n4. History of organ transplant.\n5. Positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).\n6. History of active cardiac disease.\n7. History of active pulmonary disease.\n8. Active, known, or suspected autoimmune disease.\n9. Lack of peripheral venous or central venous access, or any condition that may prevent trial sample collection and administration of SCG142.\n10. Prior exposure to any cell therapy including, but not limited to natural killer (NK) cells, cytokine-induced killer (CIK) cells, dendritic cells (DCs), cytotoxic T lymphocytes (CTLs), stem cell therapy, and CAR\u002FTCR-T cell therapy.\n11. Allergy to LD chemotherapy (cyclophosphamide or fludarabine) and\u002For any component of SCG142.\n12. Any serious medical condition or abnormality in clinical laboratory tests.",{"count":242,"type":20},66,[95,23],"This is a phase 1\u002F2, open-label, single arm, multicenter study in patients with advanced or metastatic HPV16- or HPV52-positive carcinomas who have progressed after at least one line of systemic therapy, including but not limited to combination chemotherapy and\u002For combination chemo-immunotherapy",[37,246,45,44,247,43,248],"HPV-Related Cervical Squamous Cell Carcinoma","HPV-Related Vaginal Squamous Cell Carcinoma","HPV-Related Head and Neck Cancer",[250,57,26,251,252,99,31,32,29,253,254,101,255],"Human Papilloma Virus","Head and Neck Cancer","Oropharyngeal Cancer","Anogenital Cancer","TCR T Cell","T cell receptor T cell","NOT_YET_RECRUITING","2024-07-10",{"date":259,"type":76},"2024-07-17",{"date":261,"type":20},"2024-10",{"date":263,"type":20},"2028-12",{"name":265,"class":266},"SCG Cell Therapy Pte. Ltd.","INDUSTRY"]