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

NCT05462314 | Completed

• 1 other identifier: V130
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

gastrointestinal cancer; GI cancer; metastatic cancer; microbiome; pancreas; esophagus; rectum; liver

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Relationship between treatment efficacy and microbiome diversity

  3 years

Study Arms (1)

Gastrointestinal Malignancies (pancreatic, colorectal, gastroesophageal, and hepatobiliary)

Individuals with a gastrointestinal malignancy including pancreatic, colorectal, gastroesophageal, or hepatobiliary malignancies.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will accrue subjects being treated for gastrointestinal malignancies (pancreatic, colorectal, gastroesophageal, and hepatobiliary) at MSSM who are receiving chemotherapy and/or immunotherapy. Male and female subjects, between 18 and 100 years of age, who agree to donate blood, saliva, and stool specimens taken for research purposes in the outpatient setting are eligible. The elderly will be included since many gastrointestinal malignancies affect the elderly. Subjects with known active systemic infections will be excluded due to potential laboratory contamination of other resources.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Viome: lead
• Icahn School of Medicine at Mount Sinai: collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Gastrointestinal Neoplasms; Pancreatic Neoplasms; Esophageal Neoplasms; Stomach Neoplasms; Rectal Neoplasms; Liver Neoplasms; Biliary Tract Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Head and Neck Neoplasms; Esophageal Diseases; Stomach Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Intestinal Diseases; Rectal Diseases; Liver Diseases; Biliary Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Guruduth Banavar

  Viome

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2022
• First Posted: July 18, 2022
• Study Start: March 29, 2022
• Primary Completion: January 21, 2025
• Study Completion: January 21, 2025
• Last Updated: January 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)