An observational study in GVHD, Chronic, sponsored by Ciusss de L'Est de l'Île de Montréal. Recruiting at 1 site in Canada. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-18.
Sponsored by Ciusss de L'Est de l'Île de Montréal · Observational
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.
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).
Allotransplanted women who receive a first allogeneic stem cell transplant.
Exclusion Criteria:
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.
Time frame: From -1 month of transplant until +24 months after.
Evaluate genital cGVHD treatment response
Medical evaluation of vulvovaginal cGVHD according to NIH 2014 criteria
Time frame: From diagnosis until 24 months post transplant
Evaluate the frequency of premature ovarian failure
Percentage of patients with premature ovarian failure
Time frame: 3, 6 and 12 months post transplant
Measure the incidence and prevalence of HPV infection
Number of patients with HPV infection
Time frame: 3, 6 and 12 months post transplant
Evaluate the quality of life (QoL) of allografted women
Measure of QoL using FACT-BMT standardized questionnaire
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At screening and 6,12,18 and 24 months post transplant
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Bronchiolitis Obliterans Syndrome→
Ciusss de L'Est de l'Île de Montréal