Clinical trial · Observational
Gut Microbiome in Colorectal Cancer
Gut Microbiome and Oral Fluoropyrimidine Study in Patients With Colorectal Cancer
NCT04054908CI-TRIAL-00077981GOcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a pilot feasibility study designed to investigate the alterations in the gut microbiome that occur during the course of treatment for colorectal cancer
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrointestinal Microbiome | — | UNRESOLVED | — |
| Neoplasm, Colorectal | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (3)
- label
- Cohort A
- description
- Patients treated with oral fluoropyrimidine (Capecitabine (CAP)) as part of standard of care (SOC) chemotherapy
- label
- Cohort B
- description
- Patients treated with Trifluridine/Tipiracil (TAS-102) including those receiving it in combination with Y-90 radioembolization as part of a clinical trial
- label
- Cohort C
- description
- Patients receiving CAP plus immunotherapy (pembrolizumab) and bevacizumab as part of a clinical trial.
Primary outcomes (4)
- measure
- Recruitment rate rate (percentage of patients approached that consent to participate)
- timeFrame
- Up to 2 years
- description
- Feasibility and acceptability will be assessed by evaluating percentage of patients approached that consent to participate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. The patient has histologically proven colorectal adenocarcinoma 2. The patient is starting treatment with oral fluoropyrimidine therapy: CAP or TAS-102 as SOC or on a clinical trial. This also includes those patients receiving treatment in the adjuvant setting or post-metastasectomy with no evidence of disease on imaging. 3. Combination of oral fluoropyrimidine with other cancer-directed therapies, including oxaliplatin, bevacizumab, Y-90 radioembolization, or immunotherapy checkpoint inhibitors, is permitted. 4. Combination of CAP with concurrent radiation is permitted, including patients undergoing radiotherapy to a rectal primary or a metastatic site. 5. Male or female patient aged 18 years of age or older at the time of obtaining the signed and dated informed consent (no upper age limit). 6. Be able to read and speak English. 7. Be willing and able to provide written informed consent for the study Exclusion Criteria: 1. Patient has had prior chemotherapy, biologic or immunotherapy in the previous 2 weeks. 2. Patient has completed a course of antibiotics longer than 2 weeks in preceding six months or a course of antibiotics of any duration in the 4 weeks prior to starting oral chemotherapy. Any patient who requires treatment with antibiotics during the study may be removed at the investigator's discretion. 3. Known HIV positive.
References
Publications (1)
- DERIVEDTrepka KR, Kidder WA, Kyaw TS, Halsey T, Olson CA, Ortega EF, Noecker C, Upadhyay V, Stanfield D, Steiding P, Guthrie BGH, Spanogiannopoulos P, Dumlao D, Turnbaugh JA, Stachler MD, Van Blarigan EL, Venook AP, Atreya CE, Turnbaugh PJ. Expansion of a bacterial operon during cancer treatment ameliorates fluoropyrimidine toxicity. Sci Transl Med. 2025 Apr 16;17(794):eadq8870. doi: 10.1126/scitranslmed.adq8870. Epub 2025 Apr 16. PMID 40238917