A Multicenter Cancer Biospecimen Collection Study
- Conditions
- Interventions
- Registration Number
- NCT04510129
- Lead Sponsor
- Cofactor Genomics, Inc.
- Brief Summary
This study will collect de-identified tumor samples, with correlated clinical/demographic 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...
- Detailed Description
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/PD-L1 inhibitors. Patients who have undergone pre-anti-PD-1/PD-L1-treatment tumor biopsy or who are scheduled for tumor biopsy prior to ant...
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1650
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Subject must have a disease of interest. Specifically, subject must have one of:
- head and neck squamous cell carcinoma (HNSCC)
- non-small-cell lung cancer (NSCLC)
- small cell lung cancer (SCLC)
- urothelial carcinoma (UCC)
- gastric or gastroesophageal junction adenocarcinoma
- cervical cancer
- esophageal squamous cell carcinoma (ESCC)
- triple-negative breast cancer (TNBC)
- hepatocellular carcinoma (HCC)
- renal cell carcinoma (RCC)
- colorectal cancer (CRC)
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Subject must have received, or be scheduled to receive, at least one dose of anti-PD-1/PD-L1 immunotherapy for treatment of their cancer.
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Subject must have had, or will have, a tumor biopsy prior to treatment with anti-PD-1/PD-L1 immunotherapy.
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Subject must have undergone, or will undergo, medical imaging (e.g. CT or MRI) of the tumor prior to treatment with anti-PD-1/PD-L1 immunotherapy.
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Willing to provide electronic informed consent per IRB-approved protocol.
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Able to speak, read, and comprehend English fluently.
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Subject is 18 years of age or older.
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Subjects must have sufficient tissue available to fulfill the specimen requirements of the study.
- Inability or unwillingness to provide informed consent.
- Subject who does/did not have one of the cancers listed above (other histologies).
- Subject has already participated in this trial.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description non-small-cell lung cancer (NSCLC) OncoPrism™ assay - cervical cancer OncoPrism™ assay - triple-negative breast cancer (TNBC) OncoPrism™ assay - head and neck squamous cell carcinoma (HNSCC) OncoPrism™ assay - urothelial carcinoma (UCC) OncoPrism™ assay - esophageal squamous cell carcinoma (ESCC) OncoPrism™ assay - renal cell carcinoma (RCC) OncoPrism™ assay - colorectal cancer (CRC) OncoPrism™ assay - gastric or gastroesophageal junction adenocarcinoma OncoPrism™ assay - small cell lung cancer (SCLC) OncoPrism™ assay - hepatocellular carcinoma (HCC) OncoPrism™ assay -
- Primary Outcome Measures
Name Time Method PD-L1/PD-1 inhibitor response 6 months No response to treatment with PD-L1/PD-1 inhibitor and response to treatment with PD-L1/PD-1 inhibitor.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Curebase
🇺🇸San Francisco, California, United States