Improvement of Women's Health After Allogeneic Stem Cell Transplantation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: GVHD, Chronic. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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).
Primary outcome measures
- Define the incidence and describe clinical presentation of vulvovaginal cGVHD after allogeneic stem cell transplants reflecting modern transplant practice. [Time frame: From -1 month of transplant until +24 months after.]
Secondary outcome measures (7)
- Evaluate genital cGVHD treatment response [Time frame: From diagnosis until 24 months post transplant]
- Evaluate the frequency of premature ovarian failure [Time frame: 3, 6 and 12 months post transplant]
- Measure the incidence and prevalence of HPV infection [Time frame: 3, 6 and 12 months post transplant]
- Evaluate the quality of life (QoL) of allografted women [Time frame: At screening and 3, 6, 12, 18 and 24 months post transplant]
- Evaluate intimacy within relationships of allografted women [Time frame: At screening and 6,12,18 and 24 months post transplant]
- Evaluate sexual function of allografted women [Time frame: At screening and 6,12,18 and 24 months post transplant]
- Evaluate sexual distress of allografted women [Time frame: At screening and 6,12,18 and 24 months post transplant]
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
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Canada · 1 center
- CIUSSS de l'Est-de-l'Ile-de-Montréal / Hôpital Maisonneuve-Rosemont — Montreal
Identifiers
NCT: NCT06279676 · SaFeGreff