Clinical trial NCT06279676: Improvement of Women's Health After Allogeneic Stem Cell Transplantation
Official title: Improvement of Women's Health After Allogeneic Stem Cell Transplantation
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: GVHD, Chronic
Lead sponsor: Ciusss de L'Est de l'Île de Montréal
Sponsor class: OTHER
Collaborators: name: Centre hospitalier de l'Université de Montréal (CHUM)
First posted: 2024-02-28
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Allotransplanted women who receive a first allogeneic stem cell transplant.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Define the incidence and describe clinical presentation of vulvovaginal cGVHD after allogeneic stem cell transplants reflecting modern transplant practice.
timeFrame: From -1 month of transplant until +24 months after.
Secondary outcomes:
measure: Evaluate genital cGVHD treatment response
timeFrame: From diagnosis until 24 months post transplant
measure: Evaluate the frequency of premature ovarian failure
timeFrame: 3, 6 and 12 months post transplant
measure: Measure the incidence and prevalence of HPV infection
timeFrame: 3, 6 and 12 months post transplant
measure: Evaluate the quality of life (QoL) of allografted women
timeFrame: At screening and 3, 6, 12, 18 and 24 months post transplant
measure: Evaluate intimacy within relationships of allografted women
timeFrame: At screening and 6,12,18 and 24 months post transplant
measure: Evaluate sexual function of allografted women
timeFrame: At screening and 6,12,18 and 24 months post transplant
measure: Evaluate sexual distress of allografted women
timeFrame: At screening and 6,12,18 and 24 months post transplant
Other outcomes:
Locations:
Study officials:
affiliation: CIUSSS de l'Est de l'île de Montréal/Université de Montréal
name: Jean Roy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre hospitalier de l'Université de Montréal (CHUM)
name: Marie-Hélène Mayrand, MD
role: PRINCIPAL_INVESTIGATOR
References: