[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06744296":3,"trial-entities:NCT06744296":99,"trial-summary:NCT06744296":103},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":23,"interventions":26,"primary_outcomes":33,"secondary_outcomes":38,"sex":50,"minimum_age":51,"maximum_age":21,"healthy_volunteers":14,"eligibility_criteria":52,"std_ages":66,"locations":69,"central_contacts":91,"overall_officials":95,"references":97,"see_also_links":98},"NCT06744296","2024P002675","Measurable Residual Disease Detection Using Tumor-Informed ctDNA Surveillance After Curative-Intent Treatment in HPV-Independent Squamous Cell Carcinoma of the Head and Neck","RECRUITING","2029-01-06","2025-05","2025-05-18","2025-02-03","Massachusetts Eye and Ear Infirmary","OTHER",false,"This study will test the ability of a personalized blood test to determine which head and neck cancer patients will have a recurrence after treatment.","This is a two-arm, prospective, observational study of patients with human papillomavirus (HPV)-independent head and neck squamous cell carcinoma (HNSCC) who are receiving curative-intent treatment. Arm 1 will consist of patients who undergo surgery. Arm 2 will consist of patients who undergo chemoradiotherapy.\n\nThe study will test the following hypotheses:\n\n1. That applying a tumor-informed minimal residual disease (MRD) assay after completion of curative-intent treatment will accurately discriminate between patients who will eventually experience recurrence (those are MRD positive) and patients who will remain disease-free (those who are MRD negative). The hypothesis is that patients who have detectable ctDNA following treatment-MRD positive patients-will experience recurrent disease within 2 years, while patients who have no detectable ctDNA-MRD negative patients-will remain disease free at 2 years.\n2. That measuring MRD after completion of curative-intent treatment will provide a lead time from detectable to clinical diagnosis of recurrent disease of at least 3 months.\n\nThe primary outcome is 2-year DFS in patients with detectable vs no detectable ctDNA two weeks after treatment completion.\n\nThe study will accrue 75 patients, who will be followed for a minimum of 2 years.\n\nSubjects will have blood draws before, during and following treatment at regular intervals for testing with the assay (Haystack MRD™)",[18],"Squamous Cell Carcinoma of Head and Neck",[],"OBSERVATIONAL",null,[],{"count":24,"type":25},75,"ESTIMATED",[27],{"type":13,"name":28,"description":29,"armGroupLabels":30},"Blood Draws and Tissue Sample(s)","All participants on the study, regardless of arm, will be getting blood draws, and tissue samples.",[31,32],"Patients Receiving only Surgery","Patients receiving chemoradiotherapy",[34],{"measure":35,"description":36,"timeFrame":37},"2 Years - Disease Free Survival (DFS)","2-year disease-free survival (DFS) in patients with detectable vs no detectable ctDNA two weeks after treatment completion","2 weeks after treatment completion",[39,42,46],{"measure":40,"description":41,"timeFrame":37},"2 Years - Overall Survival (OS)","2-year overall survival (OS) in patients with detectable vs no detectable ctDNA two weeks after treatment completion",{"measure":43,"description":44,"timeFrame":45},"2 Years - Disease Free Survival (DFS) and Overall Survival (OS)","2-year disease-free survival (DFS) and overall survival (OS) in patients with detectable vs no detectable ctDNA four weeks after treatment completion","4 weeks after treatment completion",{"measure":47,"description":48,"timeFrame":49},"2 - Years Disease Free Survival (DFS) and Overall Survival (OS)","2-year disease-free survival (DFS) and overall survival (OS) in patients with detectable vs no detectable ctDNA six weeks after treatment completion","6 week after treatment completion","ALL","18 Years",{"inclusion":53,"exclusion":57,"raw_text":65},[54,55,56],"Newly diagnosed AJCC 8th edition Stage III-IVB mucosal SCC of the head and neck, which includes tumors arising from the oral cavity, nasal cavity, paranasal sinuses, nasopharynx, oropharynx, hypopharynx, and larynx.","Available tissue for tumor-informed ctDNA panel creation.","Definitive treatment with standard of care surgery or chemoradiotherapy is planned to be administered at Massachusetts Eye and Ear Institute (MEEI) or within the Massachusetts General Hospital (MGH) Cancer Center (including but not limited to the Boston, Danvers, and Newton-Wellesley locations).",[58,59,60,61,62,63,64],"Patients \\\u003C18 years of age","Patients receiving non-standard of care therapy as determined by the clinical investigator","Participants who have undergone prior surgical resection, excisional biopsy, radiation, and\u002For chemotherapy for the treatment of HNSCC. Prior incisional biopsies are permitted. Discrepant cases will be reviewed by study PI.","Participants who are receiving any investigational agents at the time of enrollment.","Participants with AJCC Stage IVC HNSCC, which includes patients with biopsy-confirmed distant metastatic HNSCC, including but not limited to metastatic spread to the lungs, bones, or liver.","Active non-HNSCC malignancy.","Active pregnancy during treatment.","Inclusion Criteria:\n\n* Newly diagnosed AJCC 8th edition Stage III-IVB mucosal SCC of the head and neck, which includes tumors arising from the oral cavity, nasal cavity, paranasal sinuses, nasopharynx, oropharynx, hypopharynx, and larynx.\n* Available tissue for tumor-informed ctDNA panel creation.\n* Definitive treatment with standard of care surgery or chemoradiotherapy is planned to be administered at Massachusetts Eye and Ear Institute (MEEI) or within the Massachusetts General Hospital (MGH) Cancer Center (including but not limited to the Boston, Danvers, and Newton-Wellesley locations).\n\nExclusion Criteria:\n\n* Patients \\\u003C18 years of age\n* Patients receiving non-standard of care therapy as determined by the clinical investigator\n* Participants who have undergone prior surgical resection, excisional biopsy, radiation, and\u002For chemotherapy for the treatment of HNSCC. Prior incisional biopsies are permitted. Discrepant cases will be reviewed by study PI.\n* Participants who are receiving any investigational agents at the time of enrollment.\n* Participants with AJCC Stage IVC HNSCC, which includes patients with biopsy-confirmed distant metastatic HNSCC, including but not limited to metastatic spread to the lungs, bones, or liver.\n* Active non-HNSCC malignancy.\n* Active pregnancy during treatment.",[67,68],"ADULT","OLDER_ADULT",[70],{"facility":71,"status":7,"city":72,"state":73,"zip":74,"country":75,"contacts":76,"geoPoint":88},"Massachusetts Eye and Ear","Boston","Massachusetts","02114","United States",[77,82,85],{"name":78,"role":79,"phone":80,"email":81},"Michael Cheung, MSc, CCRP","CONTACT","617-573-6060","mcheung0@meei.harvard.edu",{"name":83,"role":79,"email":84},"Gjystina Lumaj","glumaj@meei.harvard.edu",{"name":86,"role":87},"Daniel Faden, MD","PRINCIPAL_INVESTIGATOR",{"lat":89,"lon":90},42.35843,-71.05977,[92,93],{"name":78,"role":79,"phone":80,"email":81},{"name":94,"role":79,"email":84},"Gyjstina Lumaj",[96],{"name":86,"affiliation":71,"role":87},[],[],{"nct_id":4,"conditions":100,"biomarkers":102},[101],"Head and Neck Squamous Cell Carcinoma",[],{"nct_id":4,"found":104,"summary":105,"prompt_version":115},true,{"design":106,"status":107,"heading":108,"summary":109,"follow_up":110,"word_count":111,"commitments":112,"compensation":113,"drugs_mentioned":114},"This is an observational study with two groups, aiming to enroll 75 participants. It is not a randomized study, meaning participants are not randomly assigned to different treatments.","completed","Observational Study on Personalized Blood Tests for Head and Neck Cancer Recurrence","This study is looking at a new way to predict if head and neck squamous cell carcinoma (HNSCC) will come back after treatment. It uses a personalized blood test to look for tiny amounts of cancer DNA (called circulating tumor DNA or ctDNA). The study wants to see if finding this ctDNA after treatment can accurately tell who will have their cancer return within two years. You might be able to join if you have newly diagnosed Stage III-IVB HNSCC that is not linked to HPV, and if there is enough tissue from your tumor for the special blood test. The study hopes that detecting ctDNA will show cancer recurrence at least three months before it's found by other methods. The main goal is to see how many people are cancer-free two years after treatment, based on whether ctDNA was found in their blood.","Participants will be followed for at least 2 years after treatment completion.",144,"Participants will have blood draws and tissue samples taken. You will be followed for a minimum of 2 years.","Not stated in the trial record.",[],"v2"]