Clinical trial · Observational
Characterization of the Intestinal and Vaginal Microbiota in Long-term Survivors of Gynecological Cancer
Characterization of the Intestinal and Vaginal Microbiota in Long-term Survivors of Gynecological Cancer and Its Association With Quality of Life and Sexual Health
NCT05360459CI-TRIAL-00084352completedClinicalTrials.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)
The study proposes the characterization of the intestinal and vaginal microbiota in long-term radiated cervical and endometrial cancer survivors to study the association with long-term radiotherapy side effects.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Genital Neoplasms, Female | Female Reproductive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exposure to radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Control
- description
- Healthy postmenopausal patients (more than 12 months from the last 37 menstrual period).
- label
- Gynecological Cancer
- description
- Women affected by cervical or endometrial cancer, in early stages, with a good prognosis for life, who have received radiotherapy with or without brachytherapy (radiotherapy) with or without concurrent chemotherapy.
- interventionNames
- Radiation: Exposure to radiotherapy
Primary outcomes (2)
- measure
- Fecal microbiota (fungal and bacterial)
- timeFrame
- Baseline
- description
- Abundance of bacterial taxa determined by 16SRNAr gene sequencing and abundance of fungal taxa by ITS2 gene sequencing. Bacterial species will also be determined by qPCR
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * primary diagnosis of cervical cancer or endometrial cancer. * who have received external radiotherapy (with or without brachytherapy, with or without concomitant chemotherapy) more than 24 months ago. * with clinical control in the last year that evidences that they are free of disease. * who understand Spanish and have sufficient reading level to understand the questions of the quality of life questionnaires. * sign and date the informed consent. Exclusion Criteria: * Recurrent or metastatic disease. * Treatment with antibiotics or corticosteroids (3 months prior to taking the sample). * Extreme diets (vegetarian, vegan). * Pregnancy or lactation. * Documented gastrointestinal diseases (gastric or duodenal ulcers, irritable colon, ulcerative colitis, Crohn's disease). * Alcoholism (Defined as risk consumption (20-40 gr/day in women; which would be equivalent to 2-4 gr/day) * Oral or vaginal hormone replacement therapy. * Spermicidal products in the last 48 hours. * Sexual intercourse in the last 48 hours. * Immunocompromised patients. Control patients: healthy postmenopausal women with last menstrual period more than 12 months ago in those over 40 years of age. Exclusion criteria (controls): * Previous diagnosis of gynecologic or breast cancer. * Current postmenopausal genital bleeding. * Current vulvovaginal leucorrhea.
References
Publications (0)
Data not yet available
No reference posted for this study.