Recruiting

Observational Study

Sponsor:

Ciusss de L'Est de l'Île de Montréal

Code:

NCT06279676

Conditions

GVHD, Chronic

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

GVHD, Chronic

Study ID

NCT06279676

Start date

Aug 27, 2024

Status verified date

Mar, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Define the incidence and describe clinical presentation of vulvovaginal cGVHD after allogeneic stem cell transplants reflecting modern transplant practice. [ Time Frame: From -1 month of transplant until +24 months after. ]

Central Contacts and Locations

Central contacts

Michel-Olivier Gratton

514-252-3400mogratton.hmr@ssss.gouv.qc.ca

Locations

CIUSSS de l'Est-de-l'Ile-de-Montréal / Hôpital Maisonneuve-Rosemont

Recruiting

Montreal, Quebec, Canada, H1T 2M4

Contacts

Jean Roy, Dr.

514-252-3404jean.roy.med1@ssss.gouv.qc.ca

More Information

Sponsor

Ciusss de L'Est de l'Île de Montréal

Last update posted

Mar 18, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ciusss de L'Est de l'Île de Montréal on 2026-03-18.