NCT07389863 Evaluation of Gynecological and Sexual Sequelae
| NCT ID | NCT07389863 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Rouen |
| Condition | Rectal Cancer Patients |
| Study Type | OBSERVATIONAL |
| Enrollment | 15 participants |
| Start Date | 2026-02-09 |
| Primary Completion | 2027-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 15 participants in total. It began in 2026-02-09 with a primary completion date of 2027-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Contact & Investigator
Valérie VB BRIDOUX, Professor
STUDY DIRECTOR
University Rouen Hospital
Frequently Asked Questions
Who can join the NCT07389863 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Rectal Cancer Patients. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07389863 currently recruiting?
Yes, NCT07389863 is actively recruiting participants. Contact the research team at Secretariat.DRC@chu-rouen.fr for enrollment information.
Where is the NCT07389863 trial being conducted?
This trial is being conducted at Rouen, France.
Who is sponsoring the NCT07389863 clinical trial?
NCT07389863 is sponsored by University Hospital, Rouen. The principal investigator is Valérie VB BRIDOUX, Professor at University Rouen Hospital. The trial plans to enroll 15 participants.
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