Recruiting

Observational Study

Sponsor:

UCLA

Code:

NCT06633224

Conditions

Cancer

Thoracic Cancer

Gynecologic Cancer

Head and Neck Cancer

Gastrointestinal Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Blood Specimen Collection

Stool Specimen Collection

Quality of Life (QOL) Questionnaires

Study Details

Brief summary:

Cancer-related fatigue (CRF) is a significant problem for cancer patients. This prospective, basic science, observational study will evaluate for changes in CRF associated with molecular characteristics prior to, during, and at the completion of non-investigational, standard-of-care, combined chemotherapy and radiation therapy (CCRT) and to develop and assess predictive models for CRF severity.

Conditions

Cancer

Thoracic Cancer

Gynecologic Cancer

Head and Neck Cancer

Gastrointestinal Cancer

Study ID

NCT06633224

Start date

Dec 27, 2024

Status verified date

Sep, 2025

Completion date

Sep 1, 2027

Anticipated

Primary completion date

Sep 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Participants have not received any prior treatment (i.e., cancer systemic therapies or radiation therapy) in the month except surgery or inductive Chemotherapy (CTX).
  • Participants receiving >= 15 fractions.
  • Participants is male or female and is >18 years of age on the day of signing the informed consent.
  • Ability to understand a written informed consent document.
  • Able and willing to complete all of the study questionnaires and provide blood and stool samples prior to, midway, and following the completion of treatment.
  • Willing to have medical records reviewed for clinical information.
  • Able to read, write and understand English or Spanish.

Exclusion Criteria:

  • Contraindication to phlebotomy for removal of approximately 50 mL of peripheral blood within 6 week period (Institutional Review Board (IRB) limit).

Study Design

Enrollment

125 participants

Anticipated

Interventions and Outcome Measures

Arms

Cancer Patients

Participants will have blood and stool samples collected within 5 days of any pre or post treatment timepoint prior to, during, at completion of therapy and up to 34 weeks following non-investigational, standard of care, CCRT. Participants will also be given quality of life questionnaires to complete throughout the course of the study.

Interventions

Blood Specimen Collection

Blood samples will be obtained throughout the course of the study

Stool Specimen Collection

Stool samples will be obtained throughout the course of the study

Quality of Life (QOL) Questionnaires

Surveys will be given throughout the course of the study.

Primary outcome measure

  • Measure associations between changes in cancer-related fatigue (CRF) and changes in gene expression over time [ Time Frame: Up to 34 weeks ]
  • Measure associations between changes in CRF and changes in cytokine levels over time [ Time Frame: Up to 34 weeks ]
  • Measure associations between changes in CRF and changes in gene expression over time [ Time Frame: Up to 34 weeks ]
  • Evaluate the predictive utility of gene expression and cytokine data [ Time Frame: Up to 34 weeks ]

Central Contacts and Locations

Central contacts

Jamese Johnson

(415) 530-9805Jamese.Johnson@ucsf.edu

Locations

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Jamese Johnson

415-530-9805Jamese.Johnson@ucsf.edu

877-827-3222cancertrials@ucsf.edu

Principal Investigator:

Sue Yom, MD

More Information

Sponsor

University of California, San Francisco

Last update posted

Sep 16, 2025

Last verified

Sep, 2025

Keywords

  • Basic Science Research

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2025-09-16.