Intestinal Microbiome, Oral Microbiome, And Whole Blood Transcriptome Analyses In Gastrointestinal Malignancies

Study Overview

Intestinal Microbiome, Oral Microbiome, and Whole Blood Transcriptome Analyses in Gastrointestinal Malignancies

The primary objective of this prospective observational study is to characterize the gut and oral microbiome as well as the whole blood transcriptome in gastrointestinal cancer patients and correlate these findings with cancer type, treatment efficacy and toxicity. This study will provide biospecimens from a diverse range of gastrointestinal cancer patients to allow preliminary characterization of the diversity and composition of the GIM microbiome and pilot analysis of changes in the microbiome as a function of both treatment and disease progression. This is a prospective cohort study will characterize and evaluate the microbiome of GIM patients, with various histologies. The investigators plan to enroll 200 patients with a diagnosis of gastrointestinal cancer including pancreatic, esophageal, gastric, colon, rectal, liver and biliary cancers with (i) newly diagnosed recurrent or metastatic disease initiating therapy or (ii) with progressive disease on second or later line therapies, or (iii) with locally advanced, inoperable disease receiving palliative therapy. Stool, blood and saliva samples will be collected at baseline, early in treatment (3-6 weeks), and then at 3 month intervals until progression or intolerable toxicity or up to 36 months. The results of this study are expected to provide the basis for larger, more focused studies of the microbiome in distinct GIMs and relationship to specific treatment efficacy and toxicity. Ultimately, this classification of the gastrointestinal cancer microbiome may lead to novel risk stratification paradigms, novel treatments and maintenance strategies. Furthermore, this study may lead to improved diagnostics, companion diagnostics, and nutritional interventions for cancer prevention and therapy.

Gastrointestinal Cancer
Pancreatic Cancer
Esophageal Cancer
Gastric Cancer
Rectal Cancer
Liver Cancer
Biliary Cancer

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Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2022-07-07	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-01-23
First Submitted that Met QC Criteria 2022-07-13	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-01-28
First Posted (ACTUAL) 2022-07-18	Results First Posted N/A	Last Verified 2025-01

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
: Gastrointestinal Malignancies (pancreatic, colorectal, gastroesophageal, and hepatobiliary) Individuals with a gastrointestinal malignancy including pancreatic, colorectal, gastroesophageal, or hepatobiliary malignancies.

Primary Outcome Measures	Measure Description	Time Frame
Characterization of the microbiome in Gastrointestinal Malignancy	Determining the number of species present in the sample.	3 years
Levels of gene expression of the identified species in Gastrointestinal Malignancy	Determining the levels of gene expression in the species found.	3 years

Secondary Outcome Measures	Measure Description	Time Frame
Relationship between treatment efficacy and microbiome diversity	Determination of the relationship between treatment efficacy and microbiome diversity, composition and function. Changes (increase or decrease) to the number of species and changes (increase or decrease) to their genetic expression as a result of their treatment.	3 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Histologic diagnosis of gastrointestinal malignancy including pancreatic, esophageal, gastric, colon, rectal, hepatocellular, or biliary carcinoma.
Subjects must have a) newly diagnosed recurrent or metastatic disease b) progressive disease on second or later line therapies, or c) locally advanced inoperable disease receiving palliative therapy.
Age > 18 years.
Ability to understand and willing to sign a written informed consent document.

Subjects with gastrointestinal malignancy already receiving treatment including chemotherapy, immunotherapy, radiation therapy or investigational agents for treatment of a) newly diagnosed recurrent or metastatic disease b) progressive disease on second or later line therapies, or c) locally advanced disease.
Subjects with gastrointestinal malignancy who will not be receiving cancer directed therapy including chemotherapy, immunotherapy, radiation therapy or investigational agents.
Subjects with active infectious gastroenteritis.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Icahn School of Medicine at Mount Sinai

Investigators

PRINCIPAL_INVESTIGATOR: Guruduth Banavar, Viome

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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