Correlates of CRCI and Gut Microbiome Dysbiosis; a Pilot Study
1 other identifier
observational
250
1 country
1
Brief Summary
The aim of this study is to characterize the microbiome and assess fatigue and cognition of patients with cancer undergoing standard of care treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2024
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 18, 2023
CompletedFirst Posted
Study publicly available on registry
October 24, 2023
CompletedStudy Start
First participant enrolled
March 4, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2026
December 16, 2025
December 1, 2025
2.6 years
October 18, 2023
December 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Characterization of fecal microbiome using molecular methods at baseline
Characterization of the fecal microbiome using a commercially available sampling kit and our lab's patented array for PCR at baseline
Baseline
Characterization of fecal microbiome using molecular methods at 6 months
Characterization of the fecal microbiome using a commercially available sampling kit and our lab's patented array for PCR after 6 months of standard of care treatment.
6 months
Secondary Outcomes (6)
Cognitive Function as measured by Montreal Cognitive Assessment at baseline
Baseline
Cognitive Function as measured by Montreal Cognitive Assessment at 6 months
6 months
Fatigue and Cognition as measured by the Fatigue and Altered Cognition Scale at baseline
Baseline
Fatigue and Cognition as measured by the Fatigue and Altered Cognition Scale at 6 months
6 months
Gastrointestinal Health measured by the Gastrointestinal Symptom Rating Scale at baseline
Baseline
- +1 more secondary outcomes
Study Arms (1)
Cancer Patients
Patients diagnosed with cancer undergoing standard of care treatment.
Eligibility Criteria
Subjects will be selected from community cancer clinics
You may qualify if:
- Current diagnosis of cancer.
- Ages 18 and over.
- Has access to a device (smart phone, computer, tablet) with internet access.
- Participant is willing and able to give informed consent for participation in the study.
You may not qualify if:
- Females who are pregnant or lactating.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Texas Medical Branch
Galveston, Texas, 77555, United States
Biospecimen
Blood and Stool will be coll
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Melinda Sheffield-Moore, PhD
University of Texas
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 18, 2023
First Posted
October 24, 2023
Study Start
March 4, 2024
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
October 1, 2026
Last Updated
December 16, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share