RECRUITING

The Gut Microbiome and Immunotherapy Response in Solid Cancers

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Conditions

Cancer

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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

The aim of this study is characterize the gastrointestinal microbiomes of patient with solid cancer undergoing standard of care treatment with programmed cell death protein 1 (PD-1) /programmed cell death ligand (PD-L1) blockade.

Official Title

The Gut Microbiome and Immunotherapy Response in Solid Cancers

Quick Facts

Study Start:2023-06-30
Study Completion:2025-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06050733

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:35 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Not specified
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Current diagnosis of malignant solid cancer that is nonresectable or metastatic.
  2. 2. Ages 35 to 75 years.
  3. 3. Treatment with immunotherapy, specifically programmed cell death protein 1 (PD-1) or programmed cell death ligand 1 (PD-L1) inhibitor, for at least 3 months but less than 24 months (except for previously responsive subjects re-enrolling as non-responsive patients).
  4. 4. Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 guidelines.
  5. 5. Participant is willing and able to give informed consent for participation in the study
  1. 1. Significant heart, liver, blood or respiratory disease.
  2. 2. Current diagnosis of HIV, Hepatitis B or Hepatitis C.
  3. 3. History of heart disease.
  4. 4. Uncontrolled diabetes mellitus.
  5. 5. Subjects with a history of inflammatory bowel disease, Celiac disease or active diverticular disease.
  6. 6. Females who are pregnant or lactating.
  7. 7. Treatment with chemotherapy within the past 2 years.
  8. 8. Treatment with kinase inhibitors within the past 3 months.
  9. 9. Previous radiation therapy for brain metastases.
  10. 10. Other medical condition or medication administration deemed exclusionary by the study investigators.

Contacts and Locations

Study Contact

Kristen McGovern, PhD
CONTACT
409-772-8126
kamcgove@utmb.edu
Kate Randolph, BS
CONTACT
409-223-7891
kmrandol@utmb.edu

Principal Investigator

Melinda Sheffield-Moore, PhD
PRINCIPAL_INVESTIGATOR
University of Texas

Study Locations (Sites)

University of Texas Medical Branch
Galveston, Texas, 77845
United States

Collaborators and Investigators

Sponsor: The University of Texas Medical Branch, Galveston

  • Melinda Sheffield-Moore, PhD, PRINCIPAL_INVESTIGATOR, University of Texas

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 Date2023-06-30
Study Completion Date2025-12-30

Study Record Updates

Study Start Date2023-06-30
Study Completion Date2025-12-30

Terms related to this study

Additional Relevant MeSH Terms

  • Cancer