Improving women's health after an allogeneic stem cell transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Vorinostat to help prevent GVHD in young people with non-malignant conditions undergoing stem cell transplant

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.