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

Completed

• Conditions: Biliary Cancer; Gastric Cancer; Rectal Cancer; Gastrointestinal Cancer; Esophageal Cancer; Pancreatic Cancer; Liver Cancer

• Registration Number: NCT05462314
• Lead Sponsor: Viome

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.

Detailed Description

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.

Study Timeline

• Study Start: 2022-03-29
• Study First Submitted: 2022-07-07
• Study First Submitted QC: 2022-07-13
• Study First Posted: 2022-07-18
• Status Verified: 2025-01
• Primary Completion: 2025-01-21
• Study Completion: 2025-01-21
• Last Update Submitted: 2025-01-23
• Last Update Posted: 2025-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States