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NCT Number: NCT04510129

A Multicenter Cancer Biospecimen Collection Study

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.

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Key information

Conditions

Cancer of Head and Neck Adenocarcinoma Breast Diseases Breast Neoplasms Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Hepatocellular Carcinoma, Non-Small-Cell Lung Carcinoma, Renal Cell Carcinoma, Squamous Cell Carcinoma, Transitional Cell Cervical Cancer Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Esophageal Squamous Cell Carcinoma Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastroesophageal Junction Adenocarcinoma Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Head and Neck Neoplasms Hepatocellular Carcinoma Intestinal Diseases Intestinal Neoplasms Kidney Diseases Kidney Neoplasms Liver Diseases Liver Neoplasms Lung Cancer, Nonsmall Cell Lung Diseases Lung Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell Rectal Diseases Renal Cell Carcinoma Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Small Cell Lung Carcinoma Small-cell Lung Cancer Thoracic Neoplasms Triple Negative Breast Cancer Triple Negative Breast Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Urothelial Carcinoma Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Curebase

San Francisco, California, 94131, United States

Location status: Recruiting

Location contact

Study Director

CONTACT

[email protected]

(628) 200-4082

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

OncoPrism™ assay

Diagnostic Test

OncoPrism™ is a new approach to characterizing the immune component of pre-treatment tumor tissue.

Primary outcomes

  1. PD-L1/PD-1 inhibitor response

    Time frame: 6 months

    No response to treatment with PD-L1/PD-1 inhibitor and response to treatment with PD-L1/PD-1 inhibitor.

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trial Coordinator

CONTACT

[email protected]

(888) 602-0448

Sponsors and collaborators

Lead sponsor

Cofactor Genomics, Inc.

Industry

Collaborators

  • Curebase Inc.

Registry information

Official study title

Predicting Immunotherapy Efficacy from Analysis of Pre-treatment Tumor Biopsies

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Aug 12, 2020
Registry last updated
Mar 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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