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出境医 / 临床实验 / Time Longitudinal Study of the Microbiome in Colorectal Cancer Subjects
Time Longitudinal Study of the Microbiome in Colorectal Cancer Subjects
Study Description
Brief Summary:
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.
| Condition or disease |
|---|
| Cancer Colon Gastrointestinal Disease |
Detailed Description:
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.
Study Design
| Study Type : | Observational |
| Estimated Enrollment : | 500 participants |
| Observational Model: | Case-Control |
| Time Perspective: | Prospective |
| Official Title: | Time Longitudinal Study of the Microbiome in Colorectal Cancer Subjects |
| Actual Study Start Date : | February 15, 2019 |
| Estimated Primary Completion Date : | December 31, 2025 |
| Estimated Study Completion Date : | June 30, 2026 |
Arms and Interventions
| Group/Cohort |
|---|
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Colorectal Cancer Subjects
Subjects under going colorectal resection with colorectal cancer will have tissue and stool collected
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Benign Colon Resection Subjects
Subjects under going colorectal resection without colorectal cancer will have tissue and stool collected
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Outcome Measures
Primary Outcome Measures :
- DNA/RNA Biomarkers [ Time Frame: 5 years ]Biomarkers will be defined by extracting DNA/RNA from tissue biopsies and stored for specific gene extractions.
- Microbial 16S rDNA Biomarkers [ Time Frame: 5 years ]The samples will be used to partially (V3-V5 region) amplify the microbial 16S rDNA genes through a polymerase chain reaction (PCR). The PCR product will subsequently be purified and quantified before being sequenced. They will also be used for whole genome sequencing (WGS) and Methylation sequencing (Methyl-Seq). The RNA will be used for RNAseq.
Secondary Outcome Measures :
- Protein Measurements [ Time Frame: 5 years ]Based on our initial findings protein measurements may also be performed on any extra residual specimens.
Biospecimen Retention: Samples With DNA
Tissue Biopsy
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Subjects undergoing bowel resection by any standard surgical approach at Mayo Clinic in Rochester, MN.
Criteria
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.
Contacts and Locations
Locations
| United States, Minnesota | |
| Mayo Clinic in Rochester | |
| Rochester, Minnesota, United States, 55905 | |
Sponsors and Collaborators
Mayo Clinic
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Investigators
| Principal Investigator: | Nicholas Chia, PhD | Mayo Clinic |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | May 14, 2019 | ||||
| First Posted Date | May 15, 2019 | ||||
| Last Update Posted Date | May 20, 2021 | ||||
| Actual Study Start Date | February 15, 2019 | ||||
| Estimated Primary Completion Date | December 31, 2025 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
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| Original Primary Outcome Measures |
Biomarkers [ Time Frame: 5 years ] Biomarkers will be defined by extracting DNA/RNA from tissue biopsies
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| Change History | |||||
| Current Secondary Outcome Measures |
Protein Measurements [ Time Frame: 5 years ] Based on our initial findings protein measurements may also be performed on any extra residual specimens.
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| Original Secondary Outcome Measures | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Time Longitudinal Study of the Microbiome in Colorectal Cancer Subjects | ||||
| Official Title | Time Longitudinal Study of the Microbiome in Colorectal Cancer Subjects | ||||
| Brief Summary | 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. | ||||
| Detailed Description |
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. |
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| Study Type | Observational | ||||
| Study Design | Observational Model: Case-Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples With DNA Description:
Tissue Biopsy
|
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | Subjects undergoing bowel resection by any standard surgical approach at Mayo Clinic in Rochester, MN. | ||||
| Condition |
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| Intervention | Not Provided | ||||
| Study Groups/Cohorts |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Enrolling by invitation | ||||
| Estimated Enrollment |
500 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | June 30, 2026 | ||||
| Estimated Primary Completion Date | December 31, 2025 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | United States | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03951792 | ||||
| Other Study ID Numbers | 18-009965 R01CA179243 ( U.S. NIH Grant/Contract ) |
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| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Nicholas Chia, Mayo Clinic | ||||
| Study Sponsor | Mayo Clinic | ||||
| Collaborators |
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| Investigators |
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| PRS Account | Mayo Clinic | ||||
| Verification Date | May 2021 | ||||
