What this study is
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.
What's being tested
- OncoPrism™ assay
Intervention · DIAGNOSTIC TEST
OncoPrism™ is a new approach to characterizing the immune component of pre-treatment tumor tissue.
Study details
- Official title
- Predicting Immunotherapy Efficacy from Analysis of Pre-treatment Tumor Biopsies
- Sponsor
- Cofactor Genomics, Inc.
- Conditions
- 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
- Enrolling
- 1,650 people
- Starts
- 2020-02-05
- Est. completion
- 2027-02
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openCurebase
San Francisco, California, United States
- Study Director · Contact(628) 200-4082predapthelp@curebase.com
Recruiting
Study team
Sponsor
Cofactor Genomics, Inc.
Study ID PREDAPT
Study director
Jarret Glasscock
Cofactor Genomics
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.