NCT06279676 Improvement of Women's Health After Allogeneic Stem Cell Transplantation
| NCT ID | NCT06279676 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ciusss de L'Est de l'Île de Montréal |
| Condition | GVHD, Chronic |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-08-27 |
| Primary Completion | 2028-07 |
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 100 participants in total. It began in 2024-08-27 with a primary completion date of 2028-07.
⚠ 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
The aim of this prospective research project is to better understand vulvovaginal cGVHD to improve care of allografted women. The expected outcomes include better knowledge of the incidence and manifestations of vulvovaginal cGVHD, risk factors, response to treatments and impact on sexual health of allotransplanted female patients. The knowledge acquired will allow transplant clinicians to make more precise recommendations for gynecological management of future allografted women.
Eligibility 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.
Contact & Investigator
Jean Roy, MD
PRINCIPAL INVESTIGATOR
CIUSSS de l'Est de l'île de Montréal/Université de Montréal
Frequently Asked Questions
Who can join the NCT06279676 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying GVHD, Chronic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06279676 currently recruiting?
Yes, NCT06279676 is actively recruiting participants. Contact the research team at mogratton.hmr@ssss.gouv.qc.ca for enrollment information.
Where is the NCT06279676 trial being conducted?
This trial is being conducted at Montreal, Canada.
Who is sponsoring the NCT06279676 clinical trial?
NCT06279676 is sponsored by Ciusss de L'Est de l'Île de Montréal. The principal investigator is Jean Roy, MD at CIUSSS de l'Est de l'île de Montréal/Université de Montréal. The trial plans to enroll 100 participants.