Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2025-12-24 @ 2:28 PM
NCT ID:
NCT05360459
Eligibility Criteria:
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.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT05360459
Study Brief:
Protocol Section:
NCT05360459