Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2026-01-02 @ 8:34 AM
Study NCT ID:
NCT05360459
Status:
COMPLETED
Last Update Posted:
2025-01-06
First Post:
2022-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Characterization of the Intestinal and Vaginal Microbiota in Long-term Survivors of Gynecological Cancer
Sponsor:
Maria Bailen Andrino
Organization:
Study Overview
Official Title:
Characterization of the Intestinal and Vaginal Microbiota in Long-term Survivors of Gynecological Cancer and Its Association With Quality of Life and Sexual Health
Status:
COMPLETED
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: