Gut Microbiome and Treatment for Gynecological Cancer Patients Receiving Immunotherapy
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| ClinicalTrials.gov Identifier: NCT04957511 |
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Recruitment Status :
Recruiting
First Posted : July 12, 2021
Last Update Posted : October 14, 2021
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| Condition or disease |
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| Gynecologic Cancer Immunotherapy Gut Microbiome |
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 Type : | Observational |
| Estimated Enrollment : | 30 participants |
| Observational Model: | Other |
| Time Perspective: | Prospective |
| 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 |
| Actual Study Start Date : | June 29, 2021 |
| Estimated Primary Completion Date : | June 2023 |
| Estimated Study Completion Date : | June 2023 |
- 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.
Biospecimen Retention: Samples With DNA
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Gender Based Eligibility: | Yes |
| Gender Eligibility Description: | Adult females >18 years old |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patients unable to provide fecal specimens at three time points
- Patients unable to read or understand informed consent
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Taking medications that may affect gut microbiome:
- Proton pump inhibitors (PPIs)
- Metformin
- Antibiotics
- Laxatives
- Patients who are receiving investigational agent
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04957511
| Contact: Momo Vuyisich, PhD | 855 958 4663 | momo@viome.com | |
| Contact: Ronda Ramsey, MSHS | 425 300 6933 | ronda.ramsey@viome.com |
| United States, Florida | |
| AdventHealth Cancer Institute | Recruiting |
| Orlando, Florida, United States, 32804 | |
| Contact: Jessica Chestnut 407-303-2451 Jessica.Chestnut@adventhealth.com | |
| Principal Investigator: Nathalie McKenzie, MD | |
| Sub-Investigator: Robert Holloway, MD | |
| Sub-Investigator: James Kendrick, MD | |
| Principal Investigator: | Momo Vuyisich, PhD | Viome |
| Responsible Party: | Viome |
| ClinicalTrials.gov Identifier: | NCT04957511 |
| Other Study ID Numbers: |
V235 |
| First Posted: | July 12, 2021 Key Record Dates |
| Last Update Posted: | October 14, 2021 |
| Last Verified: | October 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Biome Microbiome Gastrointestinal Immune check point inhibitors Nutrition Diet Viome |
ICI ICIs RNAseq Anti-tumor immunity Cancer Gynecology |