Improvement of Women's Health After Allogeneic Stem Cell Transplantation (SaFeGreff)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: GVHD, Chronic

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).

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Michel-Olivier Gratton; Phone Number: 2397 514-252-3400; Email: mogratton.hmr@ssss.gouv.qc.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Allotransplanted women who receive a first allogeneic stem cell transplant.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Define the incidence and describe clinical presentation of vulvovaginal cGVHD after allogeneic stem cell transplants reflecting modern transplant practice.	Prospective history, physical exam with focus on cGVHD.	From -1 month of transplant until +24 months after.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate genital cGVHD treatment response	Medical evaluation of vulvovaginal cGVHD according to NIH 2014 criteria	From diagnosis until 24 months post transplant
Evaluate the frequency of premature ovarian failure	Percentage of patients with premature ovarian failure	3, 6 and 12 months post transplant
Measure the incidence and prevalence of HPV infection	Number of patients with HPV infection	3, 6 and 12 months post transplant
Evaluate the quality of life (QoL) of allografted women	Measure of QoL using FACT-BMT standardized questionnaire	At screening and 3, 6, 12, 18 and 24 months post transplant
Evaluate intimacy within relationships of allografted women	Measure of sexual health using the Personal Assessment of Intimacy within Relationships (PAIR) standardized questionnaire	At screening and 6,12,18 and 24 months post transplant
Evaluate sexual function of allografted women	Measure of sexual health using the Female Sexual Function Index (FSFI) standardized questionnaire	At screening and 6,12,18 and 24 months post transplant
Evaluate sexual distress of allografted women	Measure of sexual health using the Female Sexual Distress Scale-Revised (FSD-R) standardized questionnaire	At screening and 6,12,18 and 24 months post transplant

Collaborators and Investigators

• Sponsor: Ciusss de L'Est de l'Île de Montréal
• Collaborators: Centre hospitalier de l'Université de Montréal (CHUM)
• Investigators: Principal Investigator: Jean Roy, MD, CIUSSS de l'Est de l'île de Montréal/Université de Montréal; Principal Investigator: Marie-Hélène Mayrand, MD, Centre Hospitalier de l'Universite de Montreal (CHUM)

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: December 15, 2023
• First Submitted That Met QC Criteria: February 19, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 19, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: SaFeGreff

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No