Graft Vs Host DiseaseNCT06649201
Vulvovaginal Graft-versus-Host Disease: Diagnosis and Microbiome Evaluation
An observational study of Graft Vs Host Disease and Vulvovaginal Signs and Symptoms, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
The goal of this observational study is to investigate the development of vulvovaginal graft-versus-host- disease (GVHD), an under-reported and under-recognized manifestation of chronic GVHD. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Graft Vs Host Disease, Vulvovaginal Signs and Symptoms
- What is being tested?
- Vulvovaginal Symptom Questionnaire and Vaginal Microbiome Evaluation
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Dec 2024to 15 Feb 2027
- 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female participants undergoing allogenic HCT will be recruited from the Blood and Marrow Transplant Program at the Cleveland Clinic.
Who may be able to join
- Female participants planning to undergo allogeneic HCT for any disease indication, OR, female participants who have already received HCT and have developed vulvovaginal GVHD during their post-transplant follow-up period
- All conditioning regimens (myeloablative or reduced intensity) will be included.
- All donor sources (HLA matched/mismatched related, unrelated, umbilical cord, haploidentical) will be included.
- All graft sources (bone marrow or peripheral blood stem cells) will be included.
- All GVHD prophylaxis regimens will be included.
- Aged 18-70.
Show all 9Show fewer
- English speaking and able to sign written informed consent.
- Participants agree to a vaginal gynecologic exam.
- Co-enrollment on other clinical trials will be allowed.
Who cannot join
- Participants who decline or unable to undergo vaginal gynecologic exam due to any discomfort or pain.
- Any concurrent medical, psychiatric or other illness in which the provider believes the participants may not be able to comply with study assessments.
- Participants with a current diagnosis of a sexually transmitted infection (STI) (Herpes Simplex Virus, Gonorrhea, Chlamydia, Trichomonas,) or a history of previously untreated STI which may incite inflammation that will impact the microbiome.
- Participants with a history of lichen sclerosis, lichen planus, pre-transplant.
- Participants with a history or current diagnosis of vaginal or vulvar malignancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195
Betty, MD, 866-223-8100, TaussigResearch@ccf.org
Betty K Hamilton, MD
About this study
The goal of this observational study is to investigate the development of vulvovaginal graft-versus-host- disease (GVHD), an under-reported and under-recognized manifestation of chronic GVHD. This study aims to characterize the vaginal microbiome in participants undergoing allogeneic hematopoietic cell transplantation (HCT). The main questions it aims to answer are:
- Is the vaginal microbiome altered during allogeneic HCT?
- What changes may help researchers understand the development of vulvovaginal GVHD?
Participants will be asked to undergo an assessment of vulvovaginal symptoms through a vulvovaginal symptom questionnaire once pre-transplant, 6 months post-transplant, and twelve12 months post- transplant. Participants will also be asked to undergo a vaginal microbiome (collection of bacteria, fungi, and viruses that live on our bodies) evaluation through a vaginal exam performed by a gynecologist with collection of vaginal samples once pre-transplant and again six months post-treatment and twelve months post-transplant. If a participant develops symptoms of vulvovaginal GVHD at any point in time during the post-transplant follow up, the participant may partake in additional vaginal exams to diagnose GVHD at the time of symptom onset.
Read the detailed description
Recent advances in technologies including high throughput metagenomic 16S rRNA gene sequencing have revealed a larger, more complex picture of the bacterial diversity in the genital tract and unique microbial communities not previously recognized among the known vaginal flora categories. Little is known about how the vaginal microbiome protects the female genital tract or other roles it may have, including interacting with the microbiota of other body sites and subsequent inflammatory responses. Alteration of vaginal flora may play a part in the pathogenesis of diseases by modulating immunity or increasing the growth of pathogenic strains. Recent research has been conducted regarding changes in the vaginal microbiome during various infectious and inflammatory states such as bacterial vaginosis, pelvic inflammatory disease, sexually transmitted infectious, and pregnancy. However, the vaginal microbiome during allogeneic HCT and development of genital GVHD has yet to be examined. Thus, the role of the vaginal microbiome in the development of genital GVHD is a critical area of study.
- Being tested
- Vulvovaginal Symptom Questionnaire, Vaginal Microbiome Evaluation
- Keywords
- Allogeneic Hematopoietic Cell Transplantation, Vaginal Microbiome, GVHD, HCT, Vulvovaginal GVHD, Vulvovaginal graft-versus-host disease
- Medical subject headings
- Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vulvovaginal Symptom QuestionnaireOther
Participants will undergo assessment of vulvovaginal symptoms via the vulvovaginal questionnaire once pre-transplant, six months, and develop months post-transplant.
Vaginal Microbiome EvaluationDiagnostic test
A vaginal microbiome evaluation will be performed via vaginal exam by a gynecologist with collection of vaginal samples once pre-transplant, six months, and twelve months post-transplant.
| Study group | Role | What they receive |
|---|---|---|
| Allogeneic HCT participants | The cohort will be comprised of participants undergoing allogeneic HCT at the Cleveland Clinic. Receives: Other: Vulvovaginal Symptom Questionnaire; Diagnostic Test: Vaginal Microbiome Evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterize the vaginal microbiome profile of female participants undergoing allogeneic HCT
A primary objective of this study is to characterize the vaginal microbiome and in female participants undergoing allogeneic HCT.
Measured: Up to twelve months post-transplant
Characterize the change in vaginal microbiome profile of female participants undergoing allogeneic HCT
A primary objective of this study is to characterize the vaginal microbiome change in female participants undergoing allogeneic HCT.
Measured: Up to twelve months post-transplant
Incidence of vulvovaginal GVHD
A primary objective is to measure the incidence of vulvovaginal GVHD in this cohort.
Measured: Up to twelve months post-transplant
Secondary outcomes (1)
Characterize the differences in vaginal microbiome between participants who develop vulvovaginal GVHS versus those who do not
The secondary objective is to investigate differences in vaginal microbiome between participants who develop vulvovaginal GVHD and those who do not.
Measured: Up to twelve 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 posted18 Oct 2024
- Study start19 Dec 2024
- Primary completionNov 2026 (estimated)
- Study completion15 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graft Vs Host DiseaseStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Incyte Corporation
- Responsible party
- Sponsor
- Investigators
- Betty K Hamilton, MD, Principal investigator, Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06649201
- Sponsor's protocol ID
- CASE2Z24
- Status last verified
- Sep 2026
- First submitted
- 17 Oct 2024
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vulvovaginal Graft-versus-Host Disease: Diagnosis and Microbiome Evaluation
- ClinicalTrials.gov ID
- NCT06649201
- Acronym / sponsor ID
- CASE2Z24
- Keywords
- Allogeneic Hematopoietic Cell Transplantation, Vaginal Microbiome, GVHD, HCT, Vulvovaginal GVHD, Vulvovaginal graft-versus-host disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Incyte Corporation
- Study start
- 19 Dec 2024 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- 15 Feb 2027 (estimated)
- First posted
- 18 Oct 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 goal of this observational study is to investigate the development of vulvovaginal graft-versus-host- disease (GVHD), an under-reported and under-recognized manifestation of chronic GVHD. This study aims to characterize the vaginal microbiome in participants undergoing allogeneic hematopoietic cell transplantation (HCT). The main questions it aims to answer are:
- Is the vaginal microbiome altered during allogeneic HCT?
- What changes may help researchers understand the development of vulvovaginal GVHD?
Participants will be asked to undergo an assessment of vulvovaginal symptoms through a vulvovaginal symptom questionnaire once pre-transplant, 6 months post-transplant, and twelve12 months post- transplant. Participants will also be asked to undergo a vaginal microbiome (collection of bacteria, fungi, and viruses that live on our bodies) evaluation through a vaginal exam performed by a gynecologist with collection of vaginal samples once pre-transplant and again six months post-treatment and twelve months post-transplant. If a participant develops symptoms of vulvovaginal GVHD at any point in time during the post-transplant follow up, the participant may partake in additional vaginal exams to diagnose GVHD at the time of symptom onset.
Detailed description
Recent advances in technologies including high throughput metagenomic 16S rRNA gene sequencing have revealed a larger, more complex picture of the bacterial diversity in the genital tract and unique microbial communities not previously recognized among the known vaginal flora categories. Little is known about how the vaginal microbiome protects the female genital tract or other roles it may have, including interacting with the microbiota of other body sites and subsequent inflammatory responses. Alteration of vaginal flora may play a part in the pathogenesis of diseases by modulating immunity or increasing the growth of pathogenic strains. Recent research has been conducted regarding changes in the vaginal microbiome during various infectious and inflammatory states such as bacterial vaginosis, pelvic inflammatory disease, sexually transmitted infectious, and pregnancy. However, the vaginal microbiome during allogeneic HCT and development of genital GVHD has yet to be examined. Thus, the role of the vaginal microbiome in the development of genital GVHD is a critical area of study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Allogeneic HCT participants | – | Other: Vulvovaginal Symptom Questionnaire, Diagnostic Test: Vaginal Microbiome EvaluationThe cohort will be comprised of participants undergoing allogeneic HCT at the Cleveland Clinic. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female participants undergoing allogenic HCT will be recruited from the Blood and Marrow Transplant Program at the Cleveland Clinic.
Key inclusion criteria (9 listed)
- Female participants planning to undergo allogeneic HCT for any disease indication, OR, female participants who have already received HCT and have developed vulvovaginal GVHD during their post-transplant follow-up period
- All conditioning regimens (myeloablative or reduced intensity) will be included.
- All donor sources (HLA matched/mismatched related, unrelated, umbilical cord, haploidentical) will be included.
- All graft sources (bone marrow or peripheral blood stem cells) will be included.
- All GVHD prophylaxis regimens will be included.
Key exclusion criteria (5 listed)
- Participants who decline or unable to undergo vaginal gynecologic exam due to any discomfort or pain.
- Any concurrent medical, psychiatric or other illness in which the provider believes the participants may not be able to comply with study assessments.
- Participants with a current diagnosis of a sexually transmitted infection (STI) (Herpes Simplex Virus, Gonorrhea, Chlamydia, Trichomonas,) or a history of previously untreated STI which may incite inflammation that will impact the microbiome.
- Participants with a history of lichen sclerosis, lichen planus, pre-transplant.
- Participants with a history or current diagnosis of vaginal or vulvar malignancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vulvovaginal Symptom QuestionnaireParticipants will undergo assessment of vulvovaginal symptoms via the vulvovaginal questionnaire once pre-transplant, six months, and develop months post-transplant. | Other | Allogeneic HCT participants |
| Vaginal Microbiome EvaluationA vaginal microbiome evaluation will be performed via vaginal exam by a gynecologist with collection of vaginal samples once pre-transplant, six months, and twelve months post-transplant. | Diagnostic test | Allogeneic HCT participants |
Primary outcome
Characterize the vaginal microbiome profile of female participants undergoing allogeneic HCT
Time frame: Up to twelve months post-transplant
A primary objective of this study is to characterize the vaginal microbiome and in female participants undergoing allogeneic HCT.
Characterize the change in vaginal microbiome profile of female participants undergoing allogeneic HCT
Time frame: Up to twelve months post-transplant
A primary objective of this study is to characterize the vaginal microbiome change in female participants undergoing allogeneic HCT.
Incidence of vulvovaginal GVHD
Time frame: Up to twelve months post-transplant
A primary objective is to measure the incidence of vulvovaginal GVHD in this cohort.
1 secondary outcome
Characterize the differences in vaginal microbiome between participants who develop vulvovaginal GVHS versus those who do not
Time frame: Up to twelve 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 29 Sep 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.
Betty K Hamilton, MD principal investigator
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
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 Graft Vs Host Disease and Vulvovaginal Signs and Symptoms, run by Case Comprehensive Cancer Center at 1 site in United States.
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 9 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 29 Sep 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 United States. 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 Betty K Hamilton, MD (1-866-223-8100, TaussigResearch@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterize the vaginal microbiome profile of female participants undergoing allogeneic HCT (time frame: Up to twelve months post-transplant). The study lists 3 primary outcomes in all. 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 29 Sep 2026.