[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06606028":3,"trial-entities:NCT06606028":111,"trial-summary:NCT06606028":116},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":23,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":28,"interventions":31,"primary_outcomes":54,"secondary_outcomes":59,"sex":74,"minimum_age":75,"maximum_age":26,"healthy_volunteers":76,"eligibility_criteria":77,"std_ages":81,"locations":84,"central_contacts":105,"overall_officials":107,"references":109,"see_also_links":110},"NCT06606028","232010","Tumor-Informed ctDNA Testing for MRD Following Treatment of Squamous Cell Carcinoma","Tumor-informed ctDNA Testing for Minimal Residual Disease Monitoring Following Curative-intent Treatment of Squamous Cell Carcinoma of the Head and Neck.","RECRUITING","2029-12-30","2025-12","2025-12-12","2024-10-09","University of California, San Francisco","OTHER",true,"This is a single-center, non-interventional, observational study that evaluates the correlation of circulating tumor DNA (ctDNA) testing to cancer relapse for participants with squamous cell carcinomas (HNC) of the head and neck mucosa and skin after curative-intent primary radiation or surgery.","PRIMARY OBJECTIVE:\n\nI. To determine the rates of detectable ctDNA within two years of participants treated with curative-intent surgery or radiation-based treatment for HNC.\n\nSECONDARY OBJECTIVES:\n\n1. To describe the prevalence of detectable ctDNA at initial diagnosis in participants with HNC.\n2. To describe the association of quantitative ctDNA levels with time-to-event outcomes (overall survival (OS), disease-free survival (DFS), and time to recurrence (TTR)).\n3. To describe the association of quantitative ctDNA levels with follow-up imaging tumor volume.\n\nOUTLINE:\n\nParticipants will have tissue samples collected at screening and blood samples collected for analysis before, during, and after non-investigational, standard of care treatment for cancer for up to 2 years",[19,20,21,22],"Squamous Cell Carcinoma of Head and Neck","Squamous Cell Carcinoma Head and Neck Cancer (HNSCC)","Squamous Cell Carcinoma of Skin","Cutaneous Squamous Cell Carcinoma (CSCC)",[24],"ctDNA","OBSERVATIONAL",null,[],{"count":29,"type":30},250,"ESTIMATED",[32,42,48],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":39},"PROCEDURE","Blood Specimen Collection","Approximately 20 mL of peripheral blood (10 mL per tube, x 3 Streck tubes) will be drawn at each time point",[37,38],"Cohort A: Non-investigational Radiation therapy","Cohort B: Non-investigational Surgery",[40,41],"Blood Specimen","Biospecimen collection",{"type":33,"name":43,"description":44,"armGroupLabels":45,"otherNames":46},"Tumor Tissue Collection","Formalin-fixed paraffin embedded tumor tissue samples (tissue blocks of 12 x 10 millimeter (mm) unstained slides) derived from biopsy or surgical resection will be collected at screening",[37,38],[47,41],"Tissue Specimen",{"type":14,"name":49,"description":50,"armGroupLabels":51,"otherNames":52},"Medical Record Review","Medical records will be reviewed to collect standard of care p16 staining by immunohistochemistry and\u002For high-risk human papillomavirus (HPV) DNA or RNA testing that is performed as part of standard of care",[37,38],[53],"Chart Review",[55],{"measure":56,"description":57,"timeFrame":58},"Cumulative incidence rate of ctDNA","Cumulative incidence will be estimated by evaluating the cumulative incidence of positive ctDNA (non-zero) with death as a competing risk.","Up to 2 years",[60,63,66,68,71],{"measure":61,"description":62,"timeFrame":58},"Proportion of participants at diagnosis with a positive (non-zero) ctDNA result.","The prevalence of detectable ctDNA at initial diagnosis in participants with locally-advanced head and neck cancer will be reported as the proportion of participants at diagnosis with a positive (non-zero) ctDNA result.",{"measure":64,"description":65,"timeFrame":58},"Association of association of quantitative ctDNA levels with overall survival (OS)","The Spearman's correlation coefficient (rs) measures the strength and direction of association between two variables. The Spearman correlation coefficient, rs, can take values from +1 to -1 where a value of +1 indicates a perfect association, an rs of 0 indicates no association and an rs of -1 indicates a perfect negative association. The closer rs is to 0, the weaker the association. This correlation will be used to determine the association of quantitative ctDNA levels with overall survival (OS).",{"measure":67,"description":65,"timeFrame":58},"Association of association of quantitative ctDNA levels with disease-free survival (DFS)",{"measure":69,"description":70,"timeFrame":58},"Association of association of quantitative ctDNA levels with time to recurrence (TTR)","The Pearson correlation coefficient (r) measures the strength and direction of association between two variables. The Pearson correlation coefficient (r) can take values from +1 to -1 where a value of +1 indicates a perfect association, a value of 0 indicates no association, and a value of -1 indicates a perfect negative association. The closer r is to 0, the weaker the association. This correlation will be used to determine the association of quantitative ctDNA levels with TTR.",{"measure":72,"description":73,"timeFrame":58},"Association of quantitative ctDNA levels with follow-up imaging tumor volume.","The Pearson correlation coefficient (r) measures the strength and direction of association between two variables. The Pearson correlation coefficient (r) can take values from +1 to -1 where a value of +1 indicates a perfect association, a value of 0 indicates no association, and a value of -1 indicates a perfect negative association. The closer r is to 0, the weaker the association. This correlation will be used to determine the association of quantitative ctDNA levels with tumor volume.","ALL","18 Years",false,{"inclusion":78,"exclusion":79,"raw_text":80},[],[],"Inclusion Criteria:\n\n1. Participants must have histologically or cytologically confirmed squamous cell carcinoma of the head and neck mucosa and skin.\n2. Participants must be age \\>=18 years.\n3. Participants must be planning to receive curative-intent surgery or radiation-based treatment as part of standard of care treatment.\n4. Participants must have the ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n1\\. Contraindication to phlebotomy for removal of 20 mL of peripheral blood each time point (up to 300 mL total over 15 time points).",[82,83],"ADULT","OLDER_ADULT",[85],{"facility":13,"status":8,"city":86,"state":87,"zip":88,"country":89,"contacts":90,"geoPoint":102},"San Francisco","California","94143","United States",[91,95,99],{"name":92,"role":93,"phone":94},"Sonia Contreras Martinez","CONTACT","415-514-6427",{"name":96,"role":93,"phone":97,"email":98},"sonia.contrerasmartinez@ucsf.edu","877-827-3222","cancertrials@ucsf.edu",{"name":100,"role":101},"Jason W Chan, MD","PRINCIPAL_INVESTIGATOR",{"lat":103,"lon":104},37.77493,-122.41942,[106],{"name":92,"role":93,"phone":94,"email":96},[108],{"name":100,"affiliation":13,"role":101},[],[],{"nct_id":4,"conditions":112,"biomarkers":115},[113,114],"Head and Neck Squamous Cell Carcinoma","Skin Squamous Cell Carcinoma",[],{"nct_id":4,"found":15,"summary":117,"prompt_version":127},{"design":118,"status":119,"heading":120,"summary":121,"follow_up":122,"word_count":123,"commitments":124,"compensation":125,"drugs_mentioned":126},"This is an observational study, meaning researchers will watch and collect information without giving new treatments. It plans to include about 250 participants.","completed","Observational Study of ctDNA Testing for Squamous Cell Carcinoma","This study is looking at how a blood test, called circulating tumor DNA (ctDNA) testing, can help doctors understand if squamous cell carcinoma (a type of skin or head and neck cancer) might come back after treatment. Researchers will collect blood and tissue samples from about 250 participants who have squamous cell carcinoma of the head and neck or skin. You would be eligible if you are 18 or older and are planning to have standard treatment like surgery or radiation. The main goal is to see how often ctDNA is found in your blood within two years after your treatment. This information could help doctors better monitor patients for cancer relapse in the future.","Participants will be followed for up to two years to measure ctDNA levels.",115,"You would provide blood samples before, during, and after your standard cancer treatment for up to two years. Tissue samples from your biopsy or surgery will also be collected at the start.","Not stated in the trial record.",[],"v2"]