Rectal Cancer PatientsGYNERECTNCT07389863
Evaluation of Gynecological and Sexual Sequelae
An observational study of Rectal Cancer Patients, run by University Hospital, Rouen at 1 site in France.
Trial summary
Rectal cancer accounts for approximately 40% of colorectal cancers. In France, there are 15,000 new cases per year, and the 5-year survival rate is 55% across all stages. Treatment involves surgical resection of the rectum, often combined with preoperative chemoradiotherapy and sometimes immunotherapy, depending on… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Rectal Cancer Patients
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 9 Feb 2026to 1 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients undergoing treatment for rectal cancer benefit from regular follow-up consultations with the digestive surgeon, allowing for the estimation of the prevalence and characteristics of sexual dysfunctions and gynecological sequelae through questionnaires.
Who may be able to join
- Women aged 18 to 60 at the time of diagnosis
- Having been treated for rectal cancer between 2020 and 2025
- Cancer in remission
- Having been sexually active before receiving treatment for their rectal cancer
- Having completed the various questionnaires during their treatment
Who cannot join
- Inability to complete questionnaires (cognitive impairment, language barrier)
- Pregnant women
- Women with active cancer and/or undergoing chemotherapy
- Women with a history of extensive gynecological surgery
- Individuals deprived of their liberty by an administrative or judicial decision, or individuals under legal protection/guardianship or curatorship
- Individuals without social security coverage
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service de Chirurgie Digestive
Rouen, 76031
Pauline PL LUDWIG, Doctor junior, 02 32 88 82 84 ext. +33, Pauline.Ludwig@chu-rouen.fr
About this study
Official title: Evaluation of Gynecological and Sexual Sequelae in Patients Treated for Rectal Cancer
Rectal cancer accounts for approximately 40% of colorectal cancers. In France, there are 15,000 new cases per year, and the 5-year survival rate is 55% across all stages. Treatment involves surgical resection of the rectum, often combined with preoperative chemoradiotherapy and sometimes immunotherapy, depending on the tumor's immunohistochemical status.
This treatment strategy has improved recurrence-free survival but is associated with long-term functional complications affecting the digestive, urological, gynecological, and sexual systems. Surgery causes anatomical changes and damage to the autonomic nervous system plexuses. Radiotherapy, for its part, causes pelvic inflammation with the development of fibrosis and potential vascular and nerve damage.
Various disorders can arise as a result of these anatomical changes, such as erectile dysfunction in men; dyspareunia and vaginal dryness in women; urinary incontinence and impaired sexual quality of life in both sexes.
Read the detailed description
In women, there is a significant link between gynecological clinical abnormalities and the onset of sexual dysfunction. Gynecological anatomical sequelae are a major determinant of female sexual health. However, their assessment in clinical practice in the context of rectal cancer remains inconsistent, incomplete, or delayed. The repercussions of impaired sexual quality of life are also significant from a public health perspective. Good sexual quality of life is directly linked to a better overall quality of life in women over 40. These results could therefore be extrapolated to patients experiencing sexual dysfunction after treatment for rectal cancer. Finally, impaired overall quality of life leads to increased healthcare utilization and disability, with significant socioeconomic repercussions.
Gynecological and sexual sequelae following treatment for rectal cancer are therefore frequent but insufficiently assessed and managed in clinical practice, despite their impact on patients' overall quality of life and on public health. This work would allow for a better understanding of these disorders in order to prevent, assess, and manage them more effectively and thus optimize patients' future quality of life.
- Conditions
- Rectal Cancer Patients
- Keywords
- Gynecological and sexual sequelae
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Prevalence of gynecological and sexual sequelae in women after treatment for rectal cancer | The prevalence and characterization of gynecological and sexual sequelae in women after treatment for rectal cancer will be carried out on the basis of questionnaires under study (FSFI, QLQ-CR29, QLQ-C30 and the GynéRect questionnaire) completed during the single follow-up visit. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the prevalence of sexual dysfunctions and gynecological sequelae in women after treatment for rectal cancer.
Evaluation of the prevalence of sexual dysfunctions and gynecological sequelae after treatment in women for rectal cancer, assessed using a standardized questionnaire combining validated questionnaires (FSFI, QLQ-C30, QLQ-CR29) and a specific GynéRect module for phenotyping disorders
Measured: 1 day
To assess the characteristics of sexual dysfunctions and gynecological sequelae in women after treatment for rectal cancer.
Evaluation of the description of sexual dysfunctions and gynecological sequelae after treatment in women for rectal cancer, assessed using a standardized questionnaire combining validated questionnaires (FSFI, QLQ-C30, QLQ-CR29) and a specific GynéRect module for phenotyping disorders
Measured: 1 day
Secondary outcomes (3)
Identify the main risk factors for gynecological and sexual sequelae in patients
The number of patients presenting the following risk factors will be assessed: menopausal status, treatment received (surgery alone, pre-operative radio-chemotherapy), surgical technique, tumor location, pelvic nerve involvement based on the medical data available in the computerized patient file and during questioning during a follow-up visit with the surgeon
Measured: 1 day
Evaluate the relevance of the GynéRect questionnaire for assessing the gynecological and sexual sequelae of patients
However, to date, no validated questionnaire exists that allows for the precise and phenotypic assessment of sexual and gynecological sequelae after treatment for rectal cancer. For this reason, we propose the GynéRect questionnaire in this study.
Measured: 1 day
Évaluer l'impact des séquelles gynécologiques et sexuelles des patientes sur leur qualité de vie globale
The criterion will be evaluated using the following questionnaires.The FSFI (Female Sexual Function Index) is an internationally validated self-administered questionnaire that assesses sexual function in women, including patients with a history of cancer. It consists of 19 questions evaluating six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. Sexual dysfunction is defined as a score of 26.55 or higher on a scale of 36. Patients with an FSFI score ≥ 26.55 are therefore considered to have impaired sexual function.
The QLQ-C30 questionnaire assesses health-related quality of life in cancer patients. It is an international standard and is recommended in most cancer clinical trials.
The QLQ-CR29 questionnaire complements the QLQ-C30 by focusing on symptoms specifically related to rectal cancer, including bowel, urinary, and sexual dysfunction.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start9 Feb 2026
- Primary completion1 May 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal Cancer PatientsStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valérie VB BRIDOUX, Professor, Study director, University Rouen HospitalPauline PL LUDWIG, Doctor junior, Principal investigator, University Rouen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07389863
- Sponsor's protocol ID
- 2025/0441/OB
- Other IDs
- 2025-A02592-47
- Acronym
- GYNERECT
- Status last verified
- May 2026
- First submitted
- 28 Jan 2026
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data provided will be the property of the sponsor and will be used solely for its own research activities.
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Gynecological and Sexual Sequelae in Patients Treated for Rectal Cancer
- ClinicalTrials.gov ID
- NCT07389863
- Acronym / sponsor ID
- GYNERECT / 2025/0441/OB
- Conditions
- Rectal Cancer Patients
- Keywords
- Gynecological and sexual sequelae
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 9 Feb 2026 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 5 Feb 2026 (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.
Rectal cancer accounts for approximately 40% of colorectal cancers. In France, there are 15,000 new cases per year, and the 5-year survival rate is 55% across all stages. Treatment involves surgical resection of the rectum, often combined with preoperative chemoradiotherapy and sometimes immunotherapy, depending on the tumor's immunohistochemical status.
This treatment strategy has improved recurrence-free survival but is associated with long-term functional complications affecting the digestive, urological, gynecological, and sexual systems. Surgery causes anatomical changes and damage to the autonomic nervous system plexuses. Radiotherapy, for its part, causes pelvic inflammation with the development of fibrosis and potential vascular and nerve damage.
Various disorders can arise as a result of these anatomical changes, such as erectile dysfunction in men; dyspareunia and vaginal dryness in women; urinary incontinence and impaired sexual quality of life in both sexes.
Detailed description
In women, there is a significant link between gynecological clinical abnormalities and the onset of sexual dysfunction. Gynecological anatomical sequelae are a major determinant of female sexual health. However, their assessment in clinical practice in the context of rectal cancer remains inconsistent, incomplete, or delayed. The repercussions of impaired sexual quality of life are also significant from a public health perspective. Good sexual quality of life is directly linked to a better overall quality of life in women over 40. These results could therefore be extrapolated to patients experiencing sexual dysfunction after treatment for rectal cancer. Finally, impaired overall quality of life leads to increased healthcare utilization and disability, with significant socioeconomic repercussions.
Gynecological and sexual sequelae following treatment for rectal cancer are therefore frequent but insufficiently assessed and managed in clinical practice, despite their impact on patients' overall quality of life and on public health. This work would allow for a better understanding of these disorders in order to prevent, assess, and manage them more effectively and thus optimize patients' future quality of life.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prevalence of gynecological and sexual sequelae in women after treatment for rectal cancer | – | –The prevalence and characterization of gynecological and sexual sequelae in women after treatment for rectal cancer will be carried out on the basis of questionnaires under study (FSFI, QLQ-CR29, QLQ-C30 and the GynéRect questionnaire) completed during the single follow-up visit. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients undergoing treatment for rectal cancer benefit from regular follow-up consultations with the digestive surgeon, allowing for the estimation of the prevalence and characteristics of sexual dysfunctions and gynecological sequelae through questionnaires.
Key inclusion criteria (5 listed)
- Women aged 18 to 60 at the time of diagnosis
- Having been treated for rectal cancer between 2020 and 2025
- Cancer in remission
- Having been sexually active before receiving treatment for their rectal cancer
- Having completed the various questionnaires during their treatment
Key exclusion criteria (6 listed)
- Inability to complete questionnaires (cognitive impairment, language barrier)
- Pregnant women
- Women with active cancer and/or undergoing chemotherapy
- Women with a history of extensive gynecological surgery
- Individuals deprived of their liberty by an administrative or judicial decision, or individuals under legal protection/guardianship or curatorship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To assess the prevalence of sexual dysfunctions and gynecological sequelae in women after treatment for rectal cancer.
Time frame: 1 day
Evaluation of the prevalence of sexual dysfunctions and gynecological sequelae after treatment in women for rectal cancer, assessed using a standardized questionnaire combining validated questionnaires (FSFI, QLQ-C30, QLQ-CR29) and a specific GynéRect module for phenotyping disorders
To assess the characteristics of sexual dysfunctions and gynecological sequelae in women after treatment for rectal cancer.
Time frame: 1 day
Evaluation of the description of sexual dysfunctions and gynecological sequelae after treatment in women for rectal cancer, assessed using a standardized questionnaire combining validated questionnaires (FSFI, QLQ-C30, QLQ-CR29) and a specific GynéRect module for phenotyping disorders
3 secondary outcomes
Identify the main risk factors for gynecological and sexual sequelae in patients
Time frame: 1 day
Evaluate the relevance of the GynéRect questionnaire for assessing the gynecological and sexual sequelae of patients
Time frame: 1 day
Évaluer l'impact des séquelles gynécologiques et sexuelles des patientes sur leur qualité de vie globale
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: No. The data provided will be the property of the sponsor and will be used solely for its own research activities.
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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.
Valérie VB BRIDOUX, Professor study director
University Rouen Hospital
Pauline PL LUDWIG, Doctor junior principal investigator
University Rouen Hospital
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 Rectal Cancer Patients, run by University Hospital, Rouen at 1 site in France.
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 6 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: looking for participants now, as of the sponsor's last update on 5 May 2026. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nabila NL LAAJAIL, Director (02 32 88 82 65 ext. +33, Secretariat.DRC@chu-rouen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the prevalence of sexual dysfunctions and gynecological sequelae in women after treatment for rectal cancer. (time frame: 1 day). 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 5 May 2026.