Predicting Immunotherapy Efficacy from Analysis of Pre-treatment Tumor Biopsies
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.
• 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.