[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04510129":3,"trial-entities:NCT04510129":104,"trial-summary:NCT04510129":114},{"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":30,"study_type":31,"primary_purpose":32,"phases":33,"enrollment_info":34,"interventions":37,"primary_outcomes":54,"secondary_outcomes":59,"sex":60,"minimum_age":61,"maximum_age":32,"healthy_volunteers":15,"eligibility_criteria":62,"std_ages":66,"locations":69,"central_contacts":85,"overall_officials":90,"references":95,"see_also_links":100},"NCT04510129","PREDAPT","A Multicenter Cancer Biospecimen Collection Study","Predicting Immunotherapy Efficacy from Analysis of Pre-treatment Tumor Biopsies","RECRUITING","2027-02","2025-03","2025-03-12","2020-02-05","Cofactor Genomics, Inc.","INDUSTRY",false,"This study will collect de-identified tumor samples, with correlated clinical\u002Fdemographic data and tissue histology, from patients selected or scheduled for pre-treatment tumor biopsy or who have had a recent pre-treatment tumor biopsy. These specimens and clinical data may be used in subsequent studies for the development and validation of a diagnostic test.","This study will establish a prospective cohort of pre-treatment tumor specimens with correlated de-identified clinical and demographic data and tissue histology from cancer patients who are undergoing treatment with PD-1\u002FPD-L1 inhibitors. Patients who have undergone pre-anti-PD-1\u002FPD-L1-treatment tumor biopsy or who are scheduled for tumor biopsy prior to anti-PD-1\u002FPD-L1 treatment will be enrolled.\n\nThe study will not require a study-specific tumor biopsy; any biopsies taken prior to treatment as part of standard of care are eligible for this study. Biopsies must not have been taken after immunotherapy treatment began.\n\nParticipants will be asked to provide their consent for the potential use of their biospecimens in subsequent studies for the development and validation of a diagnostic test.",[19,20,21,22,23,24,25,26,27,28,29],"Cancer of Head and Neck","Lung Cancer, Nonsmall Cell","Small-cell Lung Cancer","Urothelial Carcinoma","Gastroesophageal Junction Adenocarcinoma","Cervical Cancer","Esophageal Squamous Cell Carcinoma","Triple Negative Breast Cancer","Hepatocellular Carcinoma","Renal Cell Carcinoma","Colorectal Cancer",[],"OBSERVATIONAL",null,[],{"count":35,"type":36},1650,"ESTIMATED",[38],{"type":39,"name":40,"description":41,"armGroupLabels":42},"DIAGNOSTIC_TEST","OncoPrism™ assay","OncoPrism™ is a new approach to characterizing the immune component of pre-treatment tumor tissue.",[43,44,45,46,47,48,49,50,51,52,53],"cervical cancer","colorectal cancer (CRC)","esophageal squamous cell carcinoma (ESCC)","gastric or gastroesophageal junction adenocarcinoma","head and neck squamous cell carcinoma (HNSCC)","hepatocellular carcinoma (HCC)","non-small-cell lung cancer (NSCLC)","renal cell carcinoma (RCC)","small cell lung cancer (SCLC)","triple-negative breast cancer (TNBC)","urothelial carcinoma (UCC)",[55],{"measure":56,"description":57,"timeFrame":58},"PD-L1\u002FPD-1 inhibitor response","No response to treatment with PD-L1\u002FPD-1 inhibitor and response to treatment with PD-L1\u002FPD-1 inhibitor.","6 months",[],"ALL","18 Years",{"inclusion":63,"exclusion":64,"raw_text":65},[],[],"Inclusion Criteria:\n\n1. Subject must have a disease of interest. Specifically, subject must have one of:\n\n   1. head and neck squamous cell carcinoma (HNSCC)\n   2. non-small-cell lung cancer (NSCLC)\n   3. small cell lung cancer (SCLC)\n   4. urothelial carcinoma (UCC)\n   5. gastric or gastroesophageal junction adenocarcinoma\n   6. cervical cancer\n   7. esophageal squamous cell carcinoma (ESCC)\n   8. triple-negative breast cancer (TNBC)\n   9. hepatocellular carcinoma (HCC)\n   10. renal cell carcinoma (RCC)\n   11. colorectal cancer (CRC)\n2. Subject must have received, or be scheduled to receive, at least one dose of anti-PD-1\u002FPD-L1 immunotherapy for treatment of their cancer.\n3. Subject must have had, or will have, a tumor biopsy prior to treatment with anti-PD-1\u002FPD-L1 immunotherapy.\n4. Subject must have undergone, or will undergo, medical imaging (e.g. CT or MRI) of the tumor prior to treatment with anti-PD-1\u002FPD-L1 immunotherapy.\n5. Willing to provide electronic informed consent per IRB-approved protocol.\n6. Able to speak, read, and comprehend English fluently.\n7. Subject is 18 years of age or older.\n8. Subjects must have sufficient tissue available to fulfill the specimen requirements of the study.\n\nExclusion Criteria:\n\n1. Inability or unwillingness to provide informed consent.\n2. Subject who does\u002Fdid not have one of the cancers listed above (other histologies).\n3. Subject has already participated in this trial.",[67,68],"ADULT","OLDER_ADULT",[70],{"facility":71,"status":8,"city":72,"state":73,"zip":74,"country":75,"contacts":76,"geoPoint":82},"Curebase","San Francisco","California","94131","United States",[77],{"name":78,"role":79,"phone":80,"email":81},"Study Director","CONTACT","(628) 200-4082","predapthelp@curebase.com",{"lat":83,"lon":84},37.77493,-122.41942,[86],{"name":87,"role":79,"phone":88,"email":89},"Clinical Trial Coordinator","(888) 602-0448","clinicaltrials@cofactorgenomics.com",[91],{"name":92,"affiliation":93,"role":94},"Jarret Glasscock","Cofactor Genomics","STUDY_DIRECTOR",[96],{"pmid":97,"type":98,"citation":99},"39489541","DERIVED","Flanagan KC, Earls J, Hiken J, Wellinghoff RL, Ponder MM, McLeod HL, Westra WH, Vavinskaya V, Sutton L, Deichaite I, Macdonald OK, Welaya K, Wade J 3rd, Azzi G, Pippas AW, Slim J, Bank B, Sui X, Kossman SE, Shenkenberg TD, Alexander WL, Price KA, Ley J, Messina DN, Glasscock JI, Colevas AD, Cohen EEW, Adkins D, Duncavage EJ. Multicenter validation of an RNA-based assay to predict anti-PD-1 disease control in patients with recurrent or metastatic head and neck squamous cell carcinoma: the PREDAPT study. J Immunother Cancer. 2024 Nov 3;12(11):e009573. doi: 10.1136\u002Fjitc-2024-009573.",[101],{"label":102,"url":103},"Sponsor Website","https:\u002F\u002Fcofactorgenomics.com\u002F",{"nct_id":4,"conditions":105,"biomarkers":113},[106,107,108,25,23,109,27,110,111,28,112,22],"Breast Carcinoma","Cervical Carcinoma","Colorectal Carcinoma","Head and Neck Squamous Cell Carcinoma","Lung Non-Small Cell Carcinoma","Lung Small Cell Carcinoma","Solid Neoplasm",[],{"nct_id":4,"found":115,"summary":116,"prompt_version":126},true,{"design":117,"status":118,"heading":119,"summary":120,"follow_up":121,"word_count":122,"commitments":123,"compensation":124,"drugs_mentioned":125},"This is an observational study planning to enroll 1650 participants. It collects de-identified tumor samples and clinical data.","completed","Biospecimen Collection Study for Cancer","This study is collecting tumor samples and health information from people with certain cancers, including head and neck, lung, and urothelial carcinoma (bladder cancer). Researchers are using these samples to develop and test a diagnostic tool called OncoPrism™. This tool looks at specific markers (PD-1, PD-L1) in tumor tissue to understand how well people might respond to PD-1\u002FPD-L1 inhibitor treatments. The goal is to see how well these markers predict a response to treatment after 6 months. The study is currently unclear on its recruitment status.","The primary endpoint measures PD-L1\u002FPD-1 inhibitor response at 6 months.",86,"You would provide consent for your tumor samples and health information to be used. The study does not require extra biopsies; standard-of-care biopsies taken before immunotherapy are used.","Not stated in the trial record.",[],"v2"]