Clinical trial · Observational
Gut Microbiome and Treatment for Gynecological Cancer Patients Receiving Immunotherapy
Pilot Feasibility Study of the Interplay Between the Host Gut Microbiome and Efficacy of Treatment for Advanced or Recurrent Gynecological Cancer Patients Receiving Immunotherapy
NCT04957511CI-TRIAL-00085238recruitingClinicalTrials.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)
30 participants with advanced or recurrent gynecological cancer from are enrolled for this study. Eligible participants then provide fecal specimen, blood, vaginal swab, oral mucosal swab and receive food dietary recommendation. Additional samples are collected for results analysis.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gut Microbiome | — | UNRESOLVED | — |
| Gynecologic Cancer | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
| Immunotherapy | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Microbiome change through analysis of biological samples (fecal specimen, blood, vaginal swab, oral mucosal swab).
- timeFrame
- ~2 years
- description
- Changes are measured between the genetic microbiome signatures of advanced or recurrent gynecological cancer patients who are receiving immune checkpoint inhibitors.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult females \> 18 years old * Advanced or recurrent gynecological cancer patients from AHMG Advent Health Orlando Gynecologic Oncology Group * Patients for whom an immunotherapy regimen has been ordered Exclusion Criteria: * Patients unable to provide fecal specimens at three time points * Patients unable to read or understand informed consent * Taking medications that may affect gut microbiome: * Proton pump inhibitors (PPIs) * Metformin * Antibiotics * Laxatives * Patients who are receiving investigational agent
References
Publications (0)
Data not yet available
No reference posted for this study.