Status:
COMPLETED
Characterization of the Intestinal and Vaginal Microbiota in Long-term Survivors of Gynecological Cancer
Lead Sponsor:
Maria Bailen Andrino
Collaborating Sponsors:
Hospital Universitario Getafe
Conditions:
Genital Neoplasms, Female
Eligibility:
FEMALE
18+ years
Brief Summary
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 si...
Detailed Description
The human epithelial surface is colonized by a community of microorganisms, the microbiota, which disruption (dysbiosis) can impact a variety of functions, leading to inflammation, altered immunity an...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 20 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 30 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05360459
Start Date
May 20 2022
End Date
November 30 2024
Last Update
January 6 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital de Getafe
Getafe, Madrid, Spain, 28905