- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04510129
A Multicenter Cancer Biospecimen Collection Study
Predicting Immunotherapy Efficacy From Analysis of Pre-treatment Tumor Biopsies
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Sara Lapomarda
- Phone Number: (954) 547-1201
- Email: sara@cofactorgenomics.com
Study Contact Backup
- Name: Kevin Smilor
- Phone Number: 913-579-3011
- Email: kevin.smilor@curebase.com
Study Locations
-
-
California
-
San Francisco, California, United States, 94131
- Recruiting
- Curebase
-
Contact:
- Arsheen Ali
- Phone Number: 626-483-9418
- Email: arsheen@curebase.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
head and neck squamous cell carcinoma (HNSCC)
|
OncoPrism™ is a new approach to characterizing the immune component of pre-treatment tumor tissue.
|
non-small-cell lung cancer (NSCLC)
|
OncoPrism™ is a new approach to characterizing the immune component of pre-treatment tumor tissue.
|
small cell lung cancer (SCLC)
|
OncoPrism™ is a new approach to characterizing the immune component of pre-treatment tumor tissue.
|
urothelial carcinoma (UCC)
|
OncoPrism™ is a new approach to characterizing the immune component of pre-treatment tumor tissue.
|
gastric or gastroesophageal junction adenocarcinoma
|
OncoPrism™ is a new approach to characterizing the immune component of pre-treatment tumor tissue.
|
cervical cancer
|
OncoPrism™ is a new approach to characterizing the immune component of pre-treatment tumor tissue.
|
esophageal squamous cell carcinoma (ESCC)
|
OncoPrism™ is a new approach to characterizing the immune component of pre-treatment tumor tissue.
|
triple-negative breast cancer (TNBC)
|
OncoPrism™ is a new approach to characterizing the immune component of pre-treatment tumor tissue.
|
hepatocellular carcinoma (HCC)
|
OncoPrism™ is a new approach to characterizing the immune component of pre-treatment tumor tissue.
|
renal cell carcinoma (RCC)
|
OncoPrism™ is a new approach to characterizing the immune component of pre-treatment tumor tissue.
|
colorectal cancer (CRC)
|
OncoPrism™ is a new approach to characterizing the immune component of pre-treatment tumor tissue.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Jarret Glasscock, Cofactor Genomics
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Skin Diseases
- Respiratory Tract Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Breast Diseases
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Esophageal Diseases
- Neoplasms, Squamous Cell
- Carcinoma, Squamous Cell
- Esophageal Neoplasms
- Breast Neoplasms
- Head and Neck Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Carcinoma
- Small Cell Lung Carcinoma
- Triple Negative Breast Neoplasms
- Esophageal Squamous Cell Carcinoma
Other Study ID Numbers
- PREDAPT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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