Clinical trial NCT04510129: A Multicenter Cancer Biospecimen Collection Study
Official title: Predicting Immunotherapy Efficacy from Analysis of Pre-treatment Tumor Biopsies
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: 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
Lead sponsor: Cofactor Genomics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Curebase Inc.
First posted: 2020-08-12
Enrollment: 1650
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: PD-L1/PD-1 inhibitor response
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Curebase
state: California
Study officials:
affiliation: Cofactor Genomics
name: Jarret Glasscock
role: STUDY_DIRECTOR
References: