Characterization of the Intestinal and Vaginal Microbiota in Long-term Survivors of Gynecological Cancer

NCT05360459 | Completed

• 1 other identifier: Microbiota_ radiotherapy
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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 side effects.

Conditions

Genital Neoplasms, Female

Keywords

radiotherapy; microbiota

Outcome Measures

Primary Outcomes (2)

• Fecal microbiota (fungal and bacterial)

  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

  Baseline

• Vaginal microbiota (fungal and bacterial)

  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

  Baseline

Secondary Outcomes (1)

• Quality of life of participants

  Baseline

Study Arms (2)

Control

Healthy postmenopausal patients (more than 12 months from the last 37 menstrual period).

Gynecological Cancer

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.

Radiation: Exposure to radiotherapy

Interventions

Exposure to radiotherapy RADIATION

Characterization and quantification of intestinal and vaginal microbiota in patients affected by cervical or endometrial cancer who have received pelvic radiotherapy more than 24 months ago.

Gynecological Cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

\- Patients of the Gynecology and Obstetrics Department of the University Hospital of Getafe. Getafe.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Previous diagnosis of gynecologic or breast cancer.
• Current postmenopausal genital bleeding.
• Current vulvovaginal leucorrhea.

Sponsors & Collaborators

• Maria Bailen Andrino: lead
• Hospital Universitario Getafe: collaborator

Study Sites (1)

Hospital de Getafe

Getafe, Madrid, 28905, Spain

Location

Biospecimen

Retention: SAMPLES WITH DNA

vaginal swab and stool specimen

MeSH Terms

Conditions

Genital Neoplasms, Female

Condition Hierarchy (Ancestors)

Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• María Bailen Andrino, PhD

  Universidad Autonoma de Madrid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 5, 2022
• First Posted: May 4, 2022
• Study Start: May 20, 2022
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: January 6, 2025

Record last verified: 2025-01

Locations

ES (1)