A Multicenter Cancer Biospecimen Collection Study
Predicting Immunotherapy Efficacy from Analysis of Pre-treatment Tumor Biopsies
1 other identifier
observational
1,650
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2020
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 5, 2020
CompletedFirst Submitted
Initial submission to the registry
August 10, 2020
CompletedFirst Posted
Study publicly available on registry
August 12, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2027
March 12, 2025
March 1, 2025
7 years
August 10, 2020
March 10, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (11)
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)
Interventions
OncoPrism™ is a new approach to characterizing the immune component of pre-treatment tumor tissue.
Eligibility Criteria
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.
You 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.
- +4 more criteria
You may not qualify 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cofactor Genomics, Inc.lead
- Curebase Inc.collaborator
Study Sites (1)
Curebase
San Francisco, California, 94131, United States
Related Publications (1)
Flanagan KC, Earls J, Hiken J, Wellinghoff RL, Ponder MM, McLeod HL, Westra WH, Vavinskaya V, Sutton L, Deichaite I, Macdonald OK, Welaya K, Wade J 3rd, Azzi G, Pippas AW, Slim J, Bank B, Sui X, Kossman SE, Shenkenberg TD, Alexander WL, Price KA, Ley J, Messina DN, Glasscock JI, Colevas AD, Cohen EEW, Adkins D, Duncavage EJ. Multicenter validation of an RNA-based assay to predict anti-PD-1 disease control in patients with recurrent or metastatic head and neck squamous cell carcinoma: the PREDAPT study. J Immunother Cancer. 2024 Nov 3;12(11):e009573. doi: 10.1136/jitc-2024-009573.
PMID: 39489541DERIVED
Related Links
Biospecimen
Sections of subjects' pre-immunotherapy-treatment tumor biopsy, already collected as part of standard of care, will be collected as part of this study. Biopsy specimens may be used in subsequent studies for the development and validation of a diagnostic test.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jarret Glasscock
Cofactor Genomics
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 10, 2020
First Posted
August 12, 2020
Study Start
February 5, 2020
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
February 1, 2027
Last Updated
March 12, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share