Time Longitudinal Study of the Microbiome in Colorectal Cancer Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

220 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-28

Study Completion Date

2024-03-15

Brief Summary

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Researchers are trying to determine whether certain microbiome cause cancer or whether they are part of the microbiome in the gut due to the presence of cancer.

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Detailed Description

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The purpose of this research is to learn about how the gastrointestinal bacteria (microbiome) can contribute to colon cancer, and how it may change due to colon cancer. In addition, we are going to study the features of the microbiome that can help predict recovery after colon resection. To do this, we are going to compare the microbiome from subjects with colon cancer to subjects without colon cancer.

Study participation involves collection of stool samples before and after your surgery, as well as samples of residual (left-over) colon tissue from your surgery. We would also like to collect optional samples from your follow-up colonoscopy. You may be in the study for up to 5 years.

Conditions

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Cancer Colon Gastrointestinal Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Colorectal Cancer Subjects

Subjects under going colorectal resection with colorectal cancer will have tissue and stool collected

No interventions assigned to this group

Benign Colon Resection Subjects

Subjects under going colorectal resection without colorectal cancer will have tissue and stool collected

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 18 years of age or older
* Patients undergoing bowel resection by any standard surgical approach.

Exclusion Criteria

* Female that are pregnant
* Currently receiving or have received pelvic cancer radiation therapy in the past 2 weeks.
* Currently receiving or have received chemotherapy in the past 2 weeks.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No