Improvement of Women's Health After Allogeneic Stem Cell Transplantation
ConditionGVHD, Chronic
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorCiusss de L'Est de l'Île de Montréal
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Allotransplanted women who receive a first allogeneic stem cell transplant.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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.Secondary outcomes
1
Evaluate genital cGVHD treatment response
Medical evaluation of vulvovaginal cGVHD according to NIH 2014 criteria
Time frame
From diagnosis until 24 months post transplant2
Evaluate the frequency of premature ovarian failure
Percentage of patients with premature ovarian failure
Time frame
3, 6 and 12 months post transplant3
Measure the incidence and prevalence of HPV infection
Number of patients with HPV infection
Time frame
3, 6 and 12 months post transplant4
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 transplantSponsors and contacts
Click on the lead sponsor to view all of their trials.
Ciusss de L'Est de l'Île de Montréal
Lead sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborator
Source ClinicalTrials.gov