A Multicenter Cancer Biospecimen Collection Study

Study Overview
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Brief Summary
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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.

Detailed Description
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This study will establish a prospective cohort of pre-treatment tumor specimens with correlated de-identified clinical and demographic data and tissue histology from cancer patients who are undergoing treatment with PD-1/PD-L1 inhibitors. Patients who have undergone pre-anti-PD-1/PD-L1-treatment tumor biopsy or who are scheduled for tumor biopsy prior to anti-PD-1/PD-L1 treatment will be enrolled. The study will not require a study-specific tumor biopsy; any biopsies taken prior to treatment as part of standard of care are eligible for this study. Biopsies must not have been taken after immunotherapy treatment began. Participants will be asked to provide their consent for the potential use of their biospecimens in subsequent studies for the development and validation of a diagnostic test.

Official Title
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Predicting Immunotherapy Efficacy From Analysis of Pre-treatment Tumor Biopsies

Conditions
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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

Intervention / Treatment
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* Diagnostic Test: OncoPrism™ assay


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| head and neck squamous cell carcinoma (HNSCC)<br> | Diagnostic Test: OncoPrism™ assay<br>* OncoPrism™ is a new approach to characterizing the immune component of pre-treatment tumor tissue.<br>|
| non-small-cell lung cancer (NSCLC)<br> | Diagnostic Test: OncoPrism™ assay<br>* OncoPrism™ is a new approach to characterizing the immune component of pre-treatment tumor tissue.<br>|
| small cell lung cancer (SCLC)<br> | Diagnostic Test: OncoPrism™ assay<br>* OncoPrism™ is a new approach to characterizing the immune component of pre-treatment tumor tissue.<br>|
| urothelial carcinoma (UCC)<br> | Diagnostic Test: OncoPrism™ assay<br>* OncoPrism™ is a new approach to characterizing the immune component of pre-treatment tumor tissue.<br>|
| gastric or gastroesophageal junction adenocarcinoma<br> | Diagnostic Test: OncoPrism™ assay<br>* OncoPrism™ is a new approach to characterizing the immune component of pre-treatment tumor tissue.<br>|
| cervical cancer<br> | Diagnostic Test: OncoPrism™ assay<br>* OncoPrism™ is a new approach to characterizing the immune component of pre-treatment tumor tissue.<br>|
| esophageal squamous cell carcinoma (ESCC)<br> | Diagnostic Test: OncoPrism™ assay<br>* OncoPrism™ is a new approach to characterizing the immune component of pre-treatment tumor tissue.<br>|
| triple-negative breast cancer (TNBC)<br> | Diagnostic Test: OncoPrism™ assay<br>* OncoPrism™ is a new approach to characterizing the immune component of pre-treatment tumor tissue.<br>|
| hepatocellular carcinoma (HCC)<br> | Diagnostic Test: OncoPrism™ assay<br>* OncoPrism™ is a new approach to characterizing the immune component of pre-treatment tumor tissue.<br>|
| renal cell carcinoma (RCC)<br> | Diagnostic Test: OncoPrism™ assay<br>* OncoPrism™ is a new approach to characterizing the immune component of pre-treatment tumor tissue.<br>|
| colorectal cancer (CRC)<br> | Diagnostic Test: OncoPrism™ assay<br>* OncoPrism™ is a new approach to characterizing the immune component of pre-treatment tumor tissue.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PD-L1/PD-1 inhibitor response | No response to treatment with PD-L1/PD-1 inhibitor and response to treatment with PD-L1/PD-1 inhibitor. | 6 months |