CompletedNot Applicable

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

United States24 participantsStarted 2022-03-29

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Characterization of the microbiome in Gastrointestinal Malignancy

Timeframe: 3 years

Levels of gene expression of the identified species in Gastrointestinal Malignancy

Timeframe: 3 years

Trial details

NCT IDNCT05462314

SponsorViome

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-01-21

View on ClinicalTrials.gov More Gastrointestinal Cancer trials