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

  • STATUS
    Recruiting
  • End date
    Dec 19, 2025
  • participants needed
    200
  • sponsor
    Viome
Updated on 4 October 2022
cancer
carcinoma
gastrointestinal cancer

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.

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.

Details
Condition Gastrointestinal Cancer, Pancreatic Cancer, Esophageal Cancer, Gastric Cancer, Rectal Cancer, Liver Cancer, Biliary Cancer
Clinical Study IdentifierNCT05462314
SponsorViome
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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