Improvement of Women's Health After Allogeneic Stem Cell Transplantation

NCT06279676 | Recruiting

• 1 other identifier: SaFeGreff
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

GVHD, Chronic

Outcome Measures

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.

  From -1 month of transplant until +24 months after.

Secondary Outcomes (7)

• Evaluate genital cGVHD treatment response

  From diagnosis until 24 months post transplant

• Evaluate the frequency of premature ovarian failure

  3, 6 and 12 months post transplant

• Measure the incidence and prevalence of HPV infection

  3, 6 and 12 months post transplant

• Evaluate the quality of life (QoL) of allografted women

  At screening and 3, 6, 12, 18 and 24 months post transplant

• Evaluate intimacy within relationships of allografted women

  At screening and 6,12,18 and 24 months post transplant

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: All women aged 18 and over who will receive a first allogeneic HSCT
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Allotransplanted women who receive a first allogeneic stem cell transplant.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ciusss de L'Est de l'Île de Montréal: lead
• Centre hospitalier de l'Université de Montréal (CHUM): collaborator

Study Sites (1)

CIUSSS de l'Est-de-l'Ile-de-Montréal / Hôpital Maisonneuve-Rosemont

Montreal, Quebec, H1T 2M4, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Human papilloma virus (HPV) sampling will be performed to assess reactivation and sub-types.

MeSH Terms

Conditions

Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Study Officials

• Jean Roy, MD

  CIUSSS de l'Est de l'île de Montréal/Université de Montréal

  PRINCIPAL INVESTIGATOR

• Marie-Hélène Mayrand, MD

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michel-Olivier Gratton

CONTACT

514-252-3400; mogratton.hmr@ssss.gouv.qc.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2023
• First Posted: February 28, 2024
• Study Start: August 27, 2024
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)