GVHD, Chronic
Conditions
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).
Interventions
None listed
Sponsors
Ciusss de L'Est de l'Île de Montréal
Centre hospitalier de l'Université de Montréal (CHUM)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 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 |
| 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 |
Countries
Canada
Contacts
CONTACTMichel-Olivier Gratton
PRINCIPAL_INVESTIGATORJean Roy, MD
CIUSSS de l'Est de l'île de Montréal/Université de Montréal
PRINCIPAL_INVESTIGATORMarie-Hélène Mayrand, MD
Centre hospitalier de l'Université de Montréal (CHUM)
Outcome results
None listed