A Multicenter Cancer Biospecimen Collection Study

Colorectal Cancer Clinical Trial

Official title:

Predicting Immunotherapy Efficacy From Analysis of Pre-treatment Tumor Biopsies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04510129
• Other study ID #: PREDAPT
• Status: Recruiting
• Start date: February 5, 2020
• Est. completion date: February 2027

Study information

• Verified date: February 2024
• Source: Cofactor Genomics, Inc.
• Contact: Sara Lapomarda
• Phone: (954) 547-1201
• Email: sara[@]cofactorgenomics.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1650
• Est. completion date: February 2027
• Est. primary completion date: February 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Subject must have a disease of interest. Specifically, subject must have one of:

1. head and neck squamous cell carcinoma (HNSCC)

2. non-small-cell lung cancer (NSCLC)

3. small cell lung cancer (SCLC)

4. urothelial carcinoma (UCC)

5. gastric or gastroesophageal junction adenocarcinoma

6. cervical cancer

7. esophageal squamous cell carcinoma (ESCC)

8. triple-negative breast cancer (TNBC)

9. hepatocellular carcinoma (HCC)

10. renal cell carcinoma (RCC)

11. colorectal cancer (CRC)

2. 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.

3. Subject must have had, or will have, a tumor biopsy prior to treatment with anti-PD-1/PD-L1 immunotherapy.

4. 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.

5. Willing to provide electronic informed consent per IRB-approved protocol.

6. Able to speak, read, and comprehend English fluently.

7. Subject is 18 years of age or older.

8. Subjects must have sufficient tissue available to fulfill the specimen requirements of the study.

Exclusion Criteria:

1. Inability or unwillingness to provide informed consent.

2. Subject who does/did not have one of the cancers listed above (other histologies).

3. Subject has already participated in this trial.

Related Conditions & MeSH terms

• Cancer of Head and Neck
• Carcinoma
• Carcinoma, Non-Small-Cell Lung
• Cervical Cancer
• Colorectal Cancer
• Esophageal Squamous Cell Carcinoma
• Gastroesophageal Junction Adenocarcinoma
• Head and Neck Neoplasms
• Hepatocellular Carcinoma
• Lung Cancer, Nonsmall Cell
• Lung Neoplasms
• Renal Cell Carcinoma
• Small Cell Lung Carcinoma
• Small-cell Lung Cancer
• Triple Negative Breast Cancer
• Triple Negative Breast Neoplasms
• Urothelial Carcinoma

Intervention

Diagnostic Test:
• OncoPrism™ assay
OncoPrism™ is a new approach to characterizing the immune component of pre-treatment tumor tissue.

Locations

Country	Name	City	State
United States	Curebase	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
Cofactor Genomics, Inc.	Curebase Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Sponsor Website