Cancer of Head and NeckLung Cancer, Nonsmall CellSmall-cell Lung CancerUrothelial CarcinomaGastroesophageal Junction AdenocarcinomaCervical CancerEsophageal Squamous Cell CarcinomaTriple Negative Breast CancerHepatocellular CarcinomaRenal Cell CarcinomaColorectal Cancer
Investigational drug(s) / intervention(s)
OncoPrism™ assay
OncoPrism™ assay: OncoPrism™ is a new approach to characterizing the immune component of pre-treatment tumor tissue.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Subject must have a disease of interest. Specifically, subject must have one of:
1. head and neck squamous cell carcinoma (HNSCC)
2. non-small-cell lung cancer (NSCLC)
3. small cell lung cancer (SCLC)
4. urothelial carcinoma (UCC)
5. gastric or gastroesophageal junction adenocarcinoma
6. cervical cancer
7. esophageal squamous cell carcinoma (ESCC)
8. triple-negative breast cancer (TNBC)
9. hepatocellular carcinoma (HCC)
10. renal cell carcinoma (RCC)
11. colorectal cancer (CRC)
2. 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.
3. Subject must have had, or will have, a tumor biopsy prior to treatment with anti-PD-1/PD-L1 immunotherapy.
4. 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.
5. Willing to provide electronic informed consent per IRB-approved protocol.
6. Able to speak, read, and comprehend English fluently.
7. Subject is 18 years of age or older.
8. Subjects must have sufficient tissue available to fulfill the specimen requirements of the study.
Exclusion Criteria:
1. Inability or unwillingness to provide informed consent.
2. Subject who does/did not have one of the cancers listed above (other histologies).
3. Subject has already participated in this trial.
Primary outcome measure(s)
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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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