Improvement of Women's Health After Allogeneic Stem Cell Transplantation
- Conditions
- GVHD, Chronic
- Registration Number
- NCT06279676
- Lead Sponsor
- Ciusss de L'Est de l'Île de Montréal
- 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).
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 100
- 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.
- Those who receive a second HSCT allograft.
- Those who receive an autologous transplant.
- Inability to give informed consent.
- Unable to communicate in French or English.
- Any other reason which, according to the investigators, makes it preferable for a patient not to participate.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Define the incidence and describe clinical presentation of vulvovaginal cGVHD after allogeneic stem cell transplants reflecting modern transplant practice. From -1 month of transplant until +24 months after. Prospective history, physical exam with focus on cGVHD.
- Secondary Outcome Measures
Name Time Method Evaluate sexual function of allografted women At screening and 6,12,18 and 24 months post transplant Measure of sexual health using the Female Sexual Function Index (FSFI) standardized questionnaire
Measure the incidence and prevalence of HPV infection 3, 6 and 12 months post transplant Number of patients with HPV infection
Evaluate the quality of life (QoL) of allografted women At screening and 3, 6, 12, 18 and 24 months post transplant Measure of QoL using FACT-BMT standardized questionnaire
Evaluate intimacy within relationships of allografted women At screening and 6,12,18 and 24 months post transplant Measure of sexual health using the Personal Assessment of Intimacy within Relationships (PAIR) standardized questionnaire
Evaluate sexual distress of allografted women At screening and 6,12,18 and 24 months post transplant Measure of sexual health using the Female Sexual Distress Scale-Revised (FSD-R) standardized questionnaire
Evaluate genital cGVHD treatment response From diagnosis until 24 months post transplant Medical evaluation of vulvovaginal cGVHD according to NIH 2014 criteria
Evaluate the frequency of premature ovarian failure 3, 6 and 12 months post transplant Percentage of patients with premature ovarian failure