Gut Microbiome and Treatment for Gynecological Cancer Patients Receiving Immunotherapy

Gynecologic Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04957511
• Other study ID #: V235
• Status: Recruiting
• Start date: June 29, 2021
• Est. completion date: June 2024

Study information

• Verified date: June 2023
• Source: Viome
• Contact: Momchilo Vuyisich, PhD
• Phone: 855 958 4663
• Email: studies[@]viome.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gut Microbiome
• Gynecologic Cancer
• Immunotherapy

Locations

Country	Name	City	State
United States	AdventHealth Cancer Institute	Orlando	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Viome	AdventHealth

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	~2 years