GVHD, ChronicSaFeGreffNCT06279676
Improvement of Women's Health After Allogeneic Stem Cell Transplantation
An observational study of GVHD, Chronic, run by Ciusss de L'Est de l'Île de Montréal at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- GVHD, Chronic
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 27 Aug 2024to Dec 2028
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Allotransplanted women who receive a first allogeneic stem cell transplant.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
CIUSSS de l'Est-de-l'Ile-de-Montréal / Hôpital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4
Jean Roy, Dr., 514-252-3404, jean.roy.med1@ssss.gouv.qc.ca
About this study
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.
Read the 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).
- Conditions
- GVHD, Chronic
- Medical subject headings
- Bronchiolitis Obliterans Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From -1 month of transplant until +24 months after.
Secondary outcomes (7)
Evaluate genital cGVHD treatment response
Medical evaluation of vulvovaginal cGVHD according to NIH 2014 criteria
Measured: From diagnosis until 24 months post transplant
Evaluate the frequency of premature ovarian failure
Percentage of patients with premature ovarian failure
Measured: 3, 6 and 12 months post transplant
Measure the incidence and prevalence of HPV infection
Number of patients with HPV infection
Measured: 3, 6 and 12 months post transplant
Evaluate the quality of life (QoL) of allografted women
Measure of QoL using FACT-BMT standardized questionnaire
Measured: At screening and 3, 6, 12, 18 and 24 months post transplant
Evaluate intimacy within relationships of allografted women
Measure of sexual health using the Personal Assessment of Intimacy within Relationships (PAIR) standardized questionnaire
Measured: At screening and 6,12,18 and 24 months post transplant
Evaluate sexual function of allografted women
Measure of sexual health using the Female Sexual Function Index (FSFI) standardized questionnaire
Measured: At screening and 6,12,18 and 24 months post transplant
Evaluate sexual distress of allografted women
Measure of sexual health using the Female Sexual Distress Scale-Revised (FSD-R) standardized questionnaire
Measured: At screening and 6,12,18 and 24 months post transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start27 Aug 2024
- Primary completionJul 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GVHD, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Ciusss de L'Est de l'Île de Montréal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Roy, MD, Principal investigator, CIUSSS de l'Est de l'île de Montréal/Université de MontréalMarie-Hélène Mayrand, MD, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06279676
- Sponsor's protocol ID
- SaFeGreff
- Acronym
- SaFeGreff
- Status last verified
- Mar 2026
- First submitted
- 15 Dec 2023
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of Women's Health After Allogeneic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT06279676
- Acronym / sponsor ID
- SaFeGreff / SaFeGreff
- Conditions
- GVHD, Chronic
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ciusss de L'Est de l'Île de MontréalUniversity, hospital or other
- Collaborators
- Centre hospitalier de l'Université de Montréal (CHUM)
- Study start
- 27 Aug 2024 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Allotransplanted women who receive a first allogeneic stem cell transplant.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Prospective history, physical exam with focus on cGVHD.
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jean Roy, MD principal investigator
CIUSSS de l'Est de l'île de Montréal/Université de Montréal
Marie-Hélène Mayrand, MD principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of GVHD, Chronic, run by Ciusss de L'Est de l'Île de Montréal at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michel-Olivier Gratton (514-252-3400 ext. 2397, mogratton.hmr@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.