Improvement of Women's Health After Allogeneic Stem Cell Transplantation

GVHD, Chronic Clinical Trial

— SaFeGreff  

Official title:

Improvement of Women's Health After Allogeneic Stem Cell Transplantation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06279676
• Other study ID #: SaFeGreff
• Status: Not yet recruiting
• Start date: July 2024
• Est. completion date: December 2028

Study information

• Verified date: December 2023
• Source: Ciusss de L'Est de l'Île de Montréal
• Contact: Michel-Olivier Gratton
• Phone: 514-252-3400
• Email: mogratton.hmr[@]ssss.gouv.qc.ca
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2028
• Est. primary completion date: July 2028
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• GVHD, Chronic

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Ciusss de L'Est de l'Île de Montréal	Centre hospitalier de l'Université de Montréal (CHUM)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From -1 month of transplant until +24 months after.
Secondary	Evaluate genital cGVHD treatment response	Medical evaluation of vulvovaginal cGVHD according to NIH 2014 criteria	From diagnosis until 24 months post transplant
Secondary	Evaluate the frequency of premature ovarian failure	Percentage of patients with premature ovarian failure	3, 6 and 12 months post transplant
Secondary	Measure the incidence and prevalence of HPV infection	Number of patients with HPV infection	3, 6 and 12 months post transplant
Secondary	Evaluate the quality of life (QoL) of allografted women	Measure of QoL using FACT-BMT standardized questionnaire	At screening and 3, 6, 12, 18 and 24 months post transplant
Secondary	Evaluate intimacy within relationships of allografted women	Measure of sexual health using the Personal Assessment of Intimacy within Relationships (PAIR) standardized questionnaire	At screening and 6,12,18 and 24 months post transplant
Secondary	Evaluate sexual function of allografted women	Measure of sexual health using the Female Sexual Function Index (FSFI) standardized questionnaire	At screening and 6,12,18 and 24 months post transplant
Secondary	Evaluate sexual distress of allografted women	Measure of sexual health using the Female Sexual Distress Scale-Revised (FSD-R) standardized questionnaire	At screening and 6,12,18 and 24 months post transplant