Clinical trial NCT04957511: Gut Microbiome and Treatment for Gynecological Cancer Patients Receiving Immunotherapy
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: Viome
Sponsor class: INDUSTRY
Collaborators: name: AdventHealth
First posted: 2021-07-12
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Advanced or recurrent gynecological cancer patients receiving immunotherapy from AHMG Advent Health Orlando Gynecologic Oncology Group

Brief 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.

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.

Eligibility criteria: 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
* Taking medications that may affect gut microbiome:

  * Proton pump inhibitors (PPIs)
  * Metformin
  * Antibiotics
  * Laxatives
* Patients who are receiving investigational agent

Primary outcomes:
measure: Microbiome change through analysis of biological samples (fecal specimen, blood, vaginal swab, oral mucosal swab).
timeFrame: ~2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: AdventHealth Cancer Institute
state: Florida
Study officials:
affiliation: Viome Life Sciences
name: Momchilo Vuyisich, PhD
role: PRINCIPAL_INVESTIGATOR
References: