Genital Neoplasms, FemaleNCT05360459
Characterization of the Intestinal and Vaginal Microbiota in Long-term Survivors of Gynecological Cancer
An observational study of Genital Neoplasms, Female, run by Maria Bailen Andrino at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Genital Neoplasms, Female
- What is being tested?
- Exposure to radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 20 May 2022to 30 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: - Patients of the Gynecology and Obstetrics Department of the University Hospital of Getafe. Getafe.
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Genital Neoplasms, Female
- Being tested
- Exposure to radiotherapy
- Keywords
- radiotherapy, microbiota
- Medical subject headings
- Genital Neoplasms, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure to radiotherapyRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: Exposure to radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Baseline
Secondary outcomes (1)
Quality of life of participants
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start20 May 2022
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genital Neoplasms, FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maria Bailen Andrino
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario Getafe
- Responsible party
- Sponsor-investigator, Maria Bailen Andrino, Universidad Autonoma de Madrid
- Investigators
- María Bailen Andrino, PhD, Principal investigator, Universidad Autonoma de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05360459
- Sponsor's protocol ID
- Microbiota_ radiotherapy
- Status last verified
- Jan 2025
- First submitted
- 5 Apr 2022
- Last updated
- 6 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05360459
- Acronym / sponsor ID
- Microbiota_ radiotherapy
- Conditions
- Genital Neoplasms, Female
- Keywords
- radiotherapy, microbiota
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Maria Bailen AndrinoUniversity, hospital or other
- Collaborators
- Hospital Universitario Getafe
- Study start
- 20 May 2022 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 4 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | –Healthy postmenopausal patients (more than 12 months from the last 37 menstrual period). |
| Gynecological Cancer | – | Radiation: Exposure to radiotherapyWomen 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- - Patients of the Gynecology and Obstetrics Department of the University Hospital of Getafe. Getafe.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposure to radiotherapyCharacterization 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. | Radiation | Gynecological Cancer |
Primary outcome
Fecal microbiota (fungal and bacterial)
Time frame: Baseline
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
Vaginal microbiota (fungal and bacterial)
Time frame: Baseline
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
1 secondary outcome
Quality of life of participants
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
María Bailen Andrino, PhD principal investigator
Universidad Autonoma de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Genital Neoplasms, Female, run by Maria Bailen Andrino at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fecal microbiota (fungal and bacterial) (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2025.