Improvement of Women's Health After Allogeneic Stem Cell Transplantation

NCT ID: NCT06279676

Last Updated: 2024-08-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-08-31
• Study Completion Date: 2028-12-31

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.

Detailed Description

The invetigators plan to recruit 100 women who will be evaluated 9 times over a period of 2 years (before allograft, at + 3 months, +6 months, +9 months, +12 months, +15 months, +18 months, +21 months, and +24 months +/- 14 days). If a new diagnosis of cGVHD is made between 2 visits, an additional gynecological examination will be performed.

Visits by the Hôpital Maisonneuve-Rosemont Hospital transplant team will include a physical examination to assess for the presence of cGVHD using the NIH criteria. The FACT-BMT quality of life questionnaire will also be completed before the allograft, at 3 months and 6 months after transplant. If cGVHD is diagnosed, the participants will also have to complete two questionnaires specific to cGVHD (Lee Scale for cGVHD, Patient self-assessment of cGVHD) at diagnosis and then at + 6, +12, +18 and +24 months from day 0 of allograft.

Assessments by CHUM gynecologists will take place before the allograft, then at +3, +6, +12, +18 and +24 months from day 0 of the allograft and will include: a vulvar/vaginal examination, a sample for HPV testing and sexual health questionnaires to be completed (Personal assessment of intimacy within relationships - PAIR, Female Sexual Function Index - FSFI , Female Sexual Distress Scale-Revised - FSDS-R).

Conditions

GVHD, Chronic

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role: collaborator

Ciusss de L'Est de l'Île de Montréal

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean Roy, MD

Role: PRINCIPAL_INVESTIGATOR

CIUSSS de l'Est de l'île de Montréal/Université de Montréal

Marie-Hélène Mayrand, MD

Role: PRINCIPAL_INVESTIGATOR

Centre hospitalier de l'Université de Montréal (CHUM)

Central Contacts

Michel-Olivier Gratton

Role: CONTACT

mogratton.hmr@ssss.gouv.qc.ca

514-252-3400 ext. 2397

Other Identifiers

SaFeGreff

Identifier Type: -

Identifier Source: org_study_id