A Multicenter Cancer Biospecimen Collection Study
Recruiting · NCT04510129 · Observational (researchers observe without assigning treatment) · Lead sponsor: Cofactor Genomics, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
OncoPrism™ assay
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Where it is running
2 locations listed across 1 US state.
- Curebase - San Francisco, California, United States
- Curebase - San Francisco, California, United States