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

Sponsor

Viome (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05462314

Collaborator

Icahn School of Medicine at Mount Sinai (Other)

200

Enrollment

Location

44.1

Anticipated Duration (Months)

4.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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. Participants will be recruited from existing clinical sites only, no additional clinical sites are needed.

Condition or Disease	Intervention/Treatment	Phase
Gastrointestinal Cancer Pancreatic Cancer Esophageal Cancer Gastric Cancer Rectal Cancer Liver Cancer Biliary Cancer

Detailed Description

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

An Evaluation of the Intestinal Microbiome, Oral Microbiome, and Whole Blood Transcriptome Analyses in Gastrointestinal Malignancies

Actual Study Start Date :

Mar 29, 2022

Anticipated Primary Completion Date :

Dec 1, 2025

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Characterization of the microbiome in Gastrointestinal Malignancy [3 years]
Determining the number of species present in the sample.
Levels of gene expression of the identified species in Gastrointestinal Malignancy [3 years]
Determining the levels of gene expression in the species found.

Secondary Outcome Measures

Relationship between treatment efficacy and microbiome diversity [3 years]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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.