CIUSSS de l'Est-de-l'Ile-de-Montréal / Hôpital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4, Canada
Location status: Recruiting
NCT Number: NCT06279676
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.
Interested in participating?
Request Info18 year and older
Female
Observational
Montreal, Quebec, H1T 2M4, Canada
Location status: Recruiting
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: From -1 month of transplant until +24 months after.
Prospective history, physical exam with focus on cGVHD.
Time frame: From diagnosis until 24 months post transplant
Medical evaluation of vulvovaginal cGVHD according to NIH 2014 criteria
Time frame: 3, 6 and 12 months post transplant
Percentage of patients with premature ovarian failure
Time frame: 3, 6 and 12 months post transplant
Number of patients with HPV infection
Time frame: At screening and 3, 6, 12, 18 and 24 months post transplant
Measure of QoL using FACT-BMT standardized questionnaire
Time frame: 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
Time frame: At screening and 6,12,18 and 24 months post transplant
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
Measure of sexual health using the Female Sexual Distress Scale-Revised (FSD-R) standardized questionnaire
Contact information is provided by the study sponsor or research team.
Ciusss de L'Est de l'Île de Montréal
Other
Acronym: SaFeGreff
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07314892
Behavior, Behavioral Symptoms
Gdansk, Pomeranian Voivodeship, Poland
View Trial DetailsNCT06462365
Acute Lymphoblastic Leukemia, Adult B-Cell, Acute Lymphoblastic Leukemia, Adult T-Cell
Duarte, California, United States
View Trial DetailsNCT06169722
Bronchial Diseases, Bronchiolitis
Beijing, Beijing Municipality, China
View Trial DetailsNCT04930562
Bronchial Diseases, Bronchiolitis
Beijing, China
View Trial Details