RECRUITING

A Multicenter Cancer Biospecimen Collection Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Predicting Immunotherapy Efficacy From Analysis of Pre-treatment Tumor Biopsies

Quick Facts

Study Start:2020-02-05
Study Completion:2027-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04510129

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Subject must have a disease of interest. Specifically, subject must have one of:
  2. 1. head and neck squamous cell carcinoma (HNSCC)
  3. 2. non-small-cell lung cancer (NSCLC)
  4. 3. small cell lung cancer (SCLC)
  5. 4. urothelial carcinoma (UCC)
  6. 5. gastric or gastroesophageal junction adenocarcinoma
  7. 6. cervical cancer
  8. 7. esophageal squamous cell carcinoma (ESCC)
  9. 8. triple-negative breast cancer (TNBC)
  10. 9. hepatocellular carcinoma (HCC)
  11. 10. renal cell carcinoma (RCC)
  12. 11. colorectal cancer (CRC)
  13. 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.
  14. 3. Subject must have had, or will have, a tumor biopsy prior to treatment with anti-PD-1/PD-L1 immunotherapy.
  15. 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.
  16. 5. Willing to provide electronic informed consent per IRB-approved protocol.
  17. 6. Able to speak, read, and comprehend English fluently.
  18. 7. Subject is 18 years of age or older.
  19. 8. Subjects must have sufficient tissue available to fulfill the specimen requirements of the study.
  1. 1. Inability or unwillingness to provide informed consent.
  2. 2. Subject who does/did not have one of the cancers listed above (other histologies).
  3. 3. Subject has already participated in this trial.

Contacts and Locations

Study Contact

Sara Lapomarda
CONTACT
(954) 547-1201
sara@cofactorgenomics.com
Kevin Smilor
CONTACT
913-579-3011
kevin.smilor@curebase.com

Principal Investigator

Jarret Glasscock
STUDY_DIRECTOR
Cofactor Genomics

Study Locations (Sites)

Curebase
San Francisco, California, 94131
United States

Collaborators and Investigators

Sponsor: Cofactor Genomics, Inc.

  • Jarret Glasscock, STUDY_DIRECTOR, Cofactor Genomics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-02-05
Study Completion Date2027-02

Study Record Updates

Study Start Date2020-02-05
Study Completion Date2027-02

Terms related to this study

Additional Relevant MeSH Terms

  • 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