Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Behaviors and Mental Disorders

Genital Neoplasms, Female

Urogenital Neoplasms

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Quality of Life

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

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.

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.

Exposure to radiotherapy

María Bailen Andrino, PhD

María Belén Martín Salamanca, OB/GYN

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.

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 and numerous diseases, including cancer. Pelvic cancers are among the most frequently diagnosed cancers worldwide, and pelvic radiotherapy is often an essential part of multimodal therapeutic approaches but can lead to a wide range of complications for which there is currently no treatment.

The gut microbiota is altered by radiotherapy, and a relationship between gut microbiota composition, health status, and pelvic radiotherapy has been suggested. In recent years, there has been growing evidence that radiotherapy also alters the vaginal microbiota.

The study proposes the characterization of the intestinal and vaginal microbiota in long-term radiated cervical and endometrial cancer survivors to study its association with long-term radiotherapy side effects. For this purpose, a descriptive cross-sectional study will be carried out in patients affected by cervical or endometrial cancer, in early stages, with good vital prognosis who have received radiotherapy, using healthy postmenopausal women as a control group.

If the microbiota is indeed associated with the side effects of radiotherapy, this would open the possibility of identifying predictive markers, using machine learning analysis of the patients' quality of life, and would help in the search for future therapies based on the restoration of the vaginal and intestinal microbiota. Through network analysis, it would be possible to find out which factors related to patients' diet and lifestyle could be related to dysbiosis and radiotherapy-induced adverse outcomes and poor quality of life.

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

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

Quality of life of participants with gynecological cancer determined by questionnaires: EORTC QLQ-30, EORTC QLQ-EN24 and EORTC QLQ-CX24 (European Platform of Cancer Research Quality of Life Cancer Patients questionnaire) and for healthy participants determined by MENQOL questionaire

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Characterization of the Intestinal and Vaginal Microbiota in Long-term Survivors of Gynecological Cancer	NCT05360459	Genital Neoplas...	Exposure to rad...	18 Years -	Universidad Autonoma de Madrid
Characterization of the Intestinal and Vaginal Microbiota in Long-term Survivors of Gynecological Cancer	NCT05360459	Genital Neoplas...	Exposure to rad...	18 Years -	Universidad Autonoma de Madrid

Spots Global Cancer Trial Database for exposure to radiotherapy