Gynecologic CancerNCT04957511
Gut Microbiome and Treatment for Gynecological Cancer Patients Receiving Immunotherapy
An observational study of Gynecologic Cancer and Immunotherapy, run by Viome at 1 site in United States.
Trial summary
30 participants with advanced or recurrent gynecological cancer from are enrolled for this study. Eligible participants then provide fecal specimen, blood, vaginal swab, oral mucosal swab and receive food dietary recommendation. Additional samples are collected for results analysis. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynecologic Cancer, Immunotherapy, Gut Microbiome
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jun 2021to Jun 2026
- 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: Advanced or recurrent gynecological cancer patients receiving immunotherapy from AHMG Advent Health Orlando Gynecologic Oncology Group
Who may be able to join
- Adult females > 18 years old
- Advanced or recurrent gynecological cancer patients from AHMG Advent Health Orlando Gynecologic Oncology Group
- Patients for whom an immunotherapy regimen has been ordered
Who cannot join
- Patients unable to provide fecal specimens at three time points
- Patients unable to read or understand informed consent
- Taking medications that may affect gut microbiome:
- Proton pump inhibitors (PPIs)
- Metformin
- Antibiotics
- Laxatives
- Patients who are receiving investigational agent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ryan Toma, MS contact
United States1 site, 1 recruiting
- Recruiting
AdventHealth Cancer Institute
Orlando, Florida, 32804
Jessica Chestnut, 407 303 2451, Jessica.Chestnut@adventhealth.com
Nathalie McKenzie, MD
About this study
Official title: Pilot Feasibility Study of the Interplay Between the Host Gut Microbiome and Efficacy of Treatment for Advanced or Recurrent Gynecological Cancer Patients Receiving Immunotherapy
30 participants with advanced or recurrent gynecological cancer from are enrolled for this study. Eligible participants then provide fecal specimen, blood, vaginal swab, oral mucosal swab and receive food dietary recommendation. Additional samples are collected for results analysis.
Read the detailed description
30 patients diagnosed with advanced or recurrent gynecological cancer who plan to receive immunotherapy treatment with a checkpoint inhibitor at AHMG AdventHealth Orlando Gynecological Oncology Group are recruited. Patients will be recruited 1-2 weeks prior to the beginning of treatment and appropriate informed consent will be obtained. Fecal samples; blood; saliva and vaginal swab samples will be collected among participants prior to their first treatment, after four doses of immunotherapy, and again at the completion of immunotherapy (follow-up). These 4 biomarker samples will undergo metatranscriptomic analysis, also known as RNAseq, method of sample analysis. Only RNA molecules are sequenced, while DNA is degraded. for bacterial community analysis. These findings will help to design a future study to examine the role of the gut microbiome in antitumor immunity and its effect on immune checkpoint inhibitor therapy for advanced or recurrent gynecological cancer. NHANES Food Frequency Questionnaire will be collected prior to participants' first treatments.
The short-term goals of this pilot study are to obtain preliminary data on the gut bacterial microbiome of patients with advanced or recurrent gynecological cancer. The long-term goals of this study is to begin to understand how the gut microbiome changes within an individual patient undergoing immunotherapy, to gut microbiome differs among patients undergoing immunotherapy, and to examine whether the gut microbiome is associated with the response to cancer immunotherapy.
- Conditions
- Gynecologic Cancer, Immunotherapy, Gut Microbiome
- Keywords
- Biome, Microbiome, Gastrointestinal, Immune check point inhibitors, Nutrition, Diet, Viome, ICI, ICIs, RNAseq, Anti-tumor immunity, Cancer, Gynecology
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiome change through analysis of biological samples (fecal specimen, blood, vaginal swab, oral mucosal swab).
Changes are measured between the genetic microbiome signatures of advanced or recurrent gynecological cancer patients who are receiving immune checkpoint inhibitors.
Measured: ~2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start29 Jun 2021
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic CancerStudies of the same condition, open and under way.
- More trials run by ViomeThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Viome
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AdventHealth
- Responsible party
- Sponsor
- Investigators
- Momchilo Vuyisich, PhD, Principal investigator, Viome Life Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04957511
- Sponsor's protocol ID
- V235
- Status last verified
- Jan 2025
- First submitted
- 10 Jun 2021
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Feasibility Study of the Interplay Between the Host Gut Microbiome and Efficacy of Treatment for Advanced or Recurrent Gynecological Cancer Patients Receiving Immunotherapy
- ClinicalTrials.gov ID
- NCT04957511
- Acronym / sponsor ID
- V235
- Conditions
- Gynecologic Cancer, Immunotherapy, Gut Microbiome
- Keywords
- Biome, Microbiome, Gastrointestinal, Immune check point inhibitors, Nutrition, Diet, Viome, ICI
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- ViomeIndustry (pharma, biotech, devices)
- Collaborators
- AdventHealth
- Study start
- 29 Jun 2021 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 12 Jul 2021 (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.
30 participants with advanced or recurrent gynecological cancer from are enrolled for this study. Eligible participants then provide fecal specimen, blood, vaginal swab, oral mucosal swab and receive food dietary recommendation. Additional samples are collected for results analysis.
Detailed description
30 patients diagnosed with advanced or recurrent gynecological cancer who plan to receive immunotherapy treatment with a checkpoint inhibitor at AHMG AdventHealth Orlando Gynecological Oncology Group are recruited. Patients will be recruited 1-2 weeks prior to the beginning of treatment and appropriate informed consent will be obtained. Fecal samples; blood; saliva and vaginal swab samples will be collected among participants prior to their first treatment, after four doses of immunotherapy, and again at the completion of immunotherapy (follow-up). These 4 biomarker samples will undergo metatranscriptomic analysis, also known as RNAseq, method of sample analysis. Only RNA molecules are sequenced, while DNA is degraded. for bacterial community analysis. These findings will help to design a future study to examine the role of the gut microbiome in antitumor immunity and its effect on immune checkpoint inhibitor therapy for advanced or recurrent gynecological cancer. NHANES Food Frequency Questionnaire will be collected prior to participants' first treatments.
The short-term goals of this pilot study are to obtain preliminary data on the gut bacterial microbiome of patients with advanced or recurrent gynecological cancer. The long-term goals of this study is to begin to understand how the gut microbiome changes within an individual patient undergoing immunotherapy, to gut microbiome differs among patients undergoing immunotherapy, and to examine whether the gut microbiome is associated with the response to cancer immunotherapy.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Advanced or recurrent gynecological cancer patients receiving immunotherapy from AHMG Advent Health Orlando Gynecologic Oncology Group
Key inclusion criteria (3 listed)
- Adult females > 18 years old
- Advanced or recurrent gynecological cancer patients from AHMG Advent Health Orlando Gynecologic Oncology Group
- Patients for whom an immunotherapy regimen has been ordered
Key exclusion criteria (8 listed)
- Patients unable to provide fecal specimens at three time points
- Patients unable to read or understand informed consent
- Taking medications that may affect gut microbiome:
- Patients who are receiving investigational agent
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
Microbiome change through analysis of biological samples (fecal specimen, blood, vaginal swab, oral mucosal swab).
Time frame: ~2 years
Changes are measured between the genetic microbiome signatures of advanced or recurrent gynecological cancer patients who are receiving immune checkpoint inhibitors.
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 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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.
Ryan Toma, MS contact
Momchilo Vuyisich, PhD principal investigator
Viome Life Sciences
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 Gynecologic Cancer and Immunotherapy, run by Viome 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 3 inclusion and 8 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 Jan 2025. 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 Momchilo Vuyisich, PhD (855 958 4663, studies@viome.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiome change through analysis of biological samples (fecal specimen, blood, vaginal swab, oral mucosal swab). (time frame: ~2 years). 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 Jan 2025.