[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06875609":3,"trial-entities:NCT06875609":108,"trial-summary:NCT06875609":112},{"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":20,"study_type":29,"primary_purpose":15,"phases":30,"enrollment_info":31,"interventions":34,"primary_outcomes":45,"secondary_outcomes":56,"sex":63,"minimum_age":64,"maximum_age":15,"healthy_volunteers":65,"eligibility_criteria":66,"std_ages":78,"locations":81,"central_contacts":100,"overall_officials":103,"references":106,"see_also_links":107},"NCT06875609","2024P003225","ctDNA in Cutaneous Squamous Cell Carcinoma","ctDNA Clearance and ctDNA Monitoring Study in Cutaneous Squamous Cell Carcinoma","RECRUITING","2029-04-30","2026-03","2026-03-30","2025-03-24","Massachusetts Eye and Ear Infirmary","OTHER",null,"The purpose of this study is to test the potential for a liquid biopsy assay to detect residual disease after surgery in patients with cutaneous squamous cell carcinoma as well as the potential for this assay to monitor response to immunotherapy treatment.","The study aims to better understand whether circulating tumor DNA, or ctDNA, a type of personalized blood test informed by the tumor, can help monitor recurrence and treatment responses in patients with cutaneous squamous cell carcinoma (CSCC), especially during and after treatment. Blood samples will be collected during regular treatment visits or through mobile phlebotomy visits, and analyzed to study how ctDNA levels change over time. Participants will be in the study for 2 years.\n\nCirculating tumor DNA consists of small fragments of DNA shed into the bloodstream by cancer cells. It may serve as a non-invasive biomarker for detecting and monitoring CSCC, offering insights into tumor treatment response and\u002For progression. ctDNA can provide a \"liquid biopsy,\" allowing real-time tracking of tumor dynamics. Specifically, the study is researching how ctDNA levels change in patients undergoing surgery, immunotherapy, or other standard treatments. The goal is to see if ctDNA can serve as a biomarker to better understand treatment response and detect potential progression\u002F recurrence of the cancer.\n\nThis study does not involve any experimental drugs or devices. All drugs and treatments administered to participants, including surgery and immunotherapy, are part of standard of care. The ctDNA blood test is being used as a research tool and is not currently approved by the U.S. Food and Drug Administration (FDA) for monitoring CSCC. The study aims to evaluate its potential future use as a reliable biomarker.",[19],"Cutaneous Squamous Cell Carcinoma",[21,22,23,24,25,26,27,28],"Circulating Tumor DNA","CSCC","Skin cancer","Biomarker","ctDNA","Minimal Residual Disease (MRD)","Liquid Biopsy","Advanced Skin Cancer","OBSERVATIONAL",[],{"count":32,"type":33},60,"ESTIMATED",[35],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":43},"DIAGNOSTIC_TEST","Blood and Tissue Collection","Blood samples, and tissue samples will be collected from the participants, and used to determine whether circulating tumor DNA (ctDNA) testing can help monitor treatment in patients with CSCC, and to determine how ctDNA levels change in patients.",[40,41,42],"Definitive Immunotherapy Cohort","Neoadjuvant Cohort","Post-Operative Cohort",[44],"ctDNA test",[46,50,53],{"measure":47,"description":48,"timeFrame":49},"2-year recurrence-free survival (RFS) in patients with detectable vs no detectable ctDNA after surgery","To determine if there is an association between ctDNA clearance (defined as no detection of ctDNA) after surgical intervention and 2-year recurrence-free survival (RFS). The outcome will measure both ctDNA clearance (as a binary variable: detection or no detection) and RFS (measured in months). The association between these two outcomes will be analyzed as the primary outcome to determine if no detection of ctDNA is associated with longer RFS.","24 Months",{"measure":51,"description":52,"timeFrame":49},"Neoadjuvant Cohort Primary Outcome: Response Monitoring","To evaluate ctDNA as a biomarker of response to neoadjuvant immunotherapy.",{"measure":54,"description":55,"timeFrame":49},"Definitive Treatment Cohort Primary Outcome","To evaluate whether ctDNA correlates with response to immunotherapy.",[57,60],{"measure":58,"description":59,"timeFrame":49},"Post-Operative Cohort Secondary Outcome: Residual Free Survival (RFS) Surveillance over 2 Year","To evaluate RFS during the surveillance period, stratified by ctDNA test status over time to determine if ctDNA levels predict recurrence",{"measure":61,"description":62,"timeFrame":49},"Neoadjuvant Cohort Secondary Outcome: Correlation with Pathological Response","To evaluate if ctDNA correlates with pathological response to neoadjuvant therapy. This will help determine if ctDNA may one day be used to help risk stratify which patients need surgery after neoadjuvant immunotherapy.","ALL","18 Years",false,{"inclusion":67,"exclusion":72,"raw_text":77},[68,69,70,71],"Patients with surgically resectable primary CSCC with PNI (\\>0.1mm caliber nerve) or at least 2 high-risk features defined as size \\> 2cm, recurrent CSCC, LVI, immunosuppressed, poorly differentiated, and\u002For invasion \\>6mm\u002Fbeyond subcutaneous fat;","Patients with surgically resectable regional metastases not receiving neoadjuvant therapy","Patients with resectable AJCC (8th ed) Stage II, III or IV(M0) CSCC treated with neoadjuvant immunotherapy as part of standard care.","Patients with unresectable locally advanced or metastatic CSCC, AJCC (8th ed) Stage II, III, or IV), receiving immunotherapy as part of standard of care.",[73,74,75,76],"Patients with Cutaneous Squamous Cell Carcinoma not amenable to surgical resection","Patients receiving or undergoing systemic therapies.","Patients ineligible for neoadjuvant treatment.","Patients undergoing systemic therapies outside the standard of care or enrolled in conflicting clinical trials.","Post-Operative Cohort\n\nInclusion Criteria:\n\n* Patients with surgically resectable primary CSCC with PNI (\\>0.1mm caliber nerve) or at least 2 high-risk features defined as size \\> 2cm, recurrent CSCC, LVI, immunosuppressed, poorly differentiated, and\u002For invasion \\>6mm\u002Fbeyond subcutaneous fat;\n* Patients with surgically resectable regional metastases not receiving neoadjuvant therapy\n\nExclusion Criteria:\n\n* Patients with Cutaneous Squamous Cell Carcinoma not amenable to surgical resection\n* Patients receiving or undergoing systemic therapies.\n\nNeoadjuvant Cohort\n\nInclusion Criteria:\n\n* Patients with resectable AJCC (8th ed) Stage II, III or IV(M0) CSCC treated with neoadjuvant immunotherapy as part of standard care.\n\nExclusion Criteria:\n\n* Patients ineligible for neoadjuvant treatment.\n\nDefinitive Immunotherapy Cohort\n\nInclusion Criteria:\n\n* Patients with unresectable locally advanced or metastatic CSCC, AJCC (8th ed) Stage II, III, or IV), receiving immunotherapy as part of standard of care.\n\nExclusion Criteria:\n\n* Patients undergoing systemic therapies outside the standard of care or enrolled in conflicting clinical trials.",[79,80],"ADULT","OLDER_ADULT",[82],{"facility":83,"status":8,"city":84,"state":85,"zip":86,"country":87,"contacts":88,"geoPoint":97},"Massachusetts Eye and Ear","Boston","Massachusetts","02114","United States",[89,94],{"name":90,"role":91,"phone":92,"email":93},"Michael Cheung, MSc, CCRP","CONTACT","617-573-6060","mcheung0@meei.harvard.edu",{"name":95,"role":96},"Sophia Shalhout, PhD","PRINCIPAL_INVESTIGATOR",{"lat":98,"lon":99},42.35843,-71.05977,[101],{"name":90,"role":91,"phone":102,"email":93},"6175736060",[104],{"name":105,"affiliation":83,"role":96},"Sophia Z. Shalhout, PhD",[],[],{"nct_id":4,"conditions":109,"biomarkers":111},[110],"Skin Squamous Cell Carcinoma",[],{"nct_id":4,"found":113,"summary":114,"prompt_version":124},true,{"design":115,"status":116,"heading":117,"summary":118,"follow_up":119,"word_count":120,"commitments":121,"compensation":122,"drugs_mentioned":123},"This is an observational study planning to enroll 60 participants. It is not specified if it is randomized or blinded.","completed","Observational Study of ctDNA in Cutaneous Squamous Cell Carcinoma","This study is looking at how a special blood test, called circulating tumor DNA (ctDNA), can help doctors monitor treatment and detect if cutaneous squamous cell carcinoma (CSCC), a type of skin cancer, comes back. Researchers will collect blood and tissue samples from people with CSCC who are having surgery or other standard treatments like immunotherapy. They want to see if changes in ctDNA levels in your blood can show how well treatment is working or if the cancer is returning. You might be able to join if you have surgically treatable CSCC with certain features, such as nerve involvement or high-risk characteristics like a large tumor size. The main goals are to see how many people remain cancer-free for two years based on their ctDNA levels after surgery, and to monitor treatment response in other groups. This is an observational study, meaning all treatments you receive are standard care, and the ctDNA test is for research purposes only.","Participants will be followed for 24 months to assess recurrence-free survival and treatment response.",159,"You would provide blood and tissue samples during your regular treatment visits or through mobile visits. You would be in the study for 2 years.","Not stated in the trial record.",[],"v2"]