Improving women's health after an allogeneic stem cell transplant
Improvement of Women's Health After Allogeneic Stem Cell Transplantation
Ciusss de L'Est de l'Île de Montréal · NCT06279676
This project will follow women having their first allogeneic stem cell transplant to see how often vulvovaginal chronic GVHD develops and how it affects sexual health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Ciusss de L'Est de l'Île de Montréal (other) |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT06279676 on ClinicalTrials.gov |
What this trial studies
This is a prospective observational cohort that will recruit 100 women receiving a first allogeneic hematopoietic stem cell transplant and follow them for two years with scheduled evaluations. Participants will have up to nine study visits including gynecological exams, HPV testing, NIH cGVHD physical assessments, and repeated quality-of-life and sexual-health questionnaires. Additional gynecological assessments will be done if chronic GVHD is diagnosed between scheduled visits. The work is coordinated by Hôpital Maisonneuve‑Rosemont and CHUM in Montreal to identify incidence, risk factors, treatment responses, and sexual health impact of vulvovaginal cGVHD.
Who should consider this trial
Good fit: Women aged 18 or older who will receive their first allogeneic HSCT at CIUSSS de l'Est‑de‑l'Île‑de‑Montréal and who can give informed consent and communicate in French or English.
Not a fit: Women receiving a second HSCT, undergoing an autologous transplant, unable to consent, or unable to communicate in French or English are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the results could help clinicians give clearer gynecological care recommendations and improve detection and management of vulvovaginal cGVHD for transplanted women.
How similar studies have performed: Smaller observational cohorts and case series have described vulvovaginal cGVHD and post-transplant sexual dysfunction, but comprehensive prospective two-year follow-up data are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All women aged 18 and over who will receive a first allogeneic HSCT (bone marrow, peripheral blood stem cells from a related, unrelated (including cord blood) or haploidentical donor) at the CIUSSS-EMTL. Recruitment will begin when the project receives ethical approval. Recruitment period will be of 2 to 3 years. Exclusion Criteria: 1. Those who receive a second HSCT allograft. 2. Those who receive an autologous transplant. 3. Inability to give informed consent. 4. Unable to communicate in French or English. 5. Any other reason which, according to the investigators, makes it preferable for a patient not to participate.
Where this trial is running
Montreal, Quebec
- CIUSSS de l'Est-de-l'Ile-de-Montréal / Hôpital Maisonneuve-Rosemont — Montreal, Quebec, Canada (RECRUITING)
Study contacts
- Principal investigator: Jean Roy, MD — CIUSSS de l'Est de l'île de Montréal/Université de Montréal
- Study coordinator: Michel-Olivier Gratton
- Email: mogratton.hmr@ssss.gouv.qc.ca
- Phone: 514-252-3400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: GVHD, Chronic