Collects tumor biopsy samples to help develop a cancer test
Collects tumor biopsies from adults with several cancers, including lung and head and neck cancer.
Key facts
- Who runs it
- Cofactor Genomics, Inc.
- Where
- San Francisco, United StatesSee the site
- Trial code
- Registry title
- A Multicenter Cancer Biospecimen Collection Study
- Status
- Recruiting
- People taking part
- 1,650 people, planned
- Started
- 5 Feb 2020
- Expected to end
- Feb 2027
- Type of study
- Observational, 11 groups
- Treatments tested
- OncoPrism™ assay
- Record updated
- 12 March 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with one of several cancers who have had, or will have, a tumor biopsy before anti-PD-1/PD-L1 immunotherapy. Tumor samples and clinical data will be collected for a future diagnostic test.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- One of these cancers: head and neck squamous cell carcinoma, non-small-cell lung cancer, small cell lung cancer, urothelial carcinoma, gastric or gastroesophageal junction adenocarcinoma, cervical cancer, esophageal squamous cell carcinoma, triple-negative breast cancer, hepatocellular carcinoma, renal cell carcinoma, or colorectal cancer.
- Earlier treatment
- Must have received, or be scheduled to receive, at least one dose of anti-PD-1/PD-L1 immunotherapy. A tumor biopsy and imaging (for example CT or MRI) must be done before this treatment.
Main reasons for not taking part
- Cannot or will not give informed consent
- Has a cancer type that is not on the list
- Has already taken part in this trial
- Not enough tissue available for the study
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- 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)
- 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
- Subject must have had, or will have, a tumor biopsy prior to treatment with anti-PD-1/PD-L1 immunotherapy
- 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
- Willing to provide electronic informed consent per IRB-approved protocol
- Able to speak, read, and comprehend English fluently
- Subject is 18 years of age or older
- Subjects must have sufficient tissue available to fulfill the specimen requirements of the study
Who cannot take part
- Subject who does/did not have one of the cancers listed above (other histologies)
- Inability or unwillingness to provide informed consent
- Subject has already participated in this trial
Where in United States
- CurebaseSan Francisco, United StatesContact: Study DirectorTaking people
About the trial
What the trial wants to find out
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.
The 11 groups in the trial
- head and neck squamous cell carcinoma (HNSCC)
Treatment: OncoPrism™ assay
- non-small-cell lung cancer (NSCLC)
Treatment: OncoPrism™ assay
- small cell lung cancer (SCLC)
Treatment: OncoPrism™ assay
- urothelial carcinoma (UCC)
Treatment: OncoPrism™ assay
- gastric or gastroesophageal junction adenocarcinoma
Treatment: OncoPrism™ assay
- cervical cancer
Treatment: OncoPrism™ assay
- esophageal squamous cell carcinoma (ESCC)
Treatment: OncoPrism™ assay
- triple-negative breast cancer (TNBC)
Treatment: OncoPrism™ assay
- hepatocellular carcinoma (HCC)
Treatment: OncoPrism™ assay
- renal cell carcinoma (RCC)
Treatment: OncoPrism™ assay
- colorectal cancer (CRC)
Treatment: OncoPrism™ assay
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Predicting Immunotherapy Efficacy from Analysis of Pre-treatment Tumor Biopsies
- Plain-language title
- Collects tumor biopsy samples to help develop a cancer testGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Publications
- Validation of a tissue-based predictive RNA test for immunotherapy benefit in NSCLC: the PREDAPT study.NPJ precision oncology, 2026
- Record updated
- 12 March 2025