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Comparison of Expression of Carcinogenesis-related Molecular Markers in the Patients With Colon Cancer and Polyp

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05638542
Recruitment Status : Active, not recruiting
First Posted : December 6, 2022
Last Update Posted : December 6, 2022
Sponsor:
Information provided by (Responsible Party):
Nayoung Kim, Seoul National University Bundang Hospital

Study Description
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Brief Summary:
A study of carcinogenesis-related molecular markers in the patients with colorectal cancer and colorectal adenoma.

Condition or disease
Colorectal Cancer Colorectal Adenoma

Detailed Description:
The chromosomal instability (CIN) pathway, the CpG island methylator phenotype (CIMP) pathway and the microsatellite instability (MSI) pathway are three major carcinogenesis pathways to colorectal cancer (CRC). In this study, the investigators aimed to investigate distinctive molecular features of carcinogenesis pathways among healthy control, colorectal adenoma, and CRC and compare their molecular progression according to patients' sex and tumor location as well as disease stage.
Study Design
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Study Type : Observational
Actual Enrollment : 582 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Comparison of Expression of Carcinogenesis-related Molecular Markers in the Patients With Colon Cancer and Polyp
Actual Study Start Date : March 1, 2015
Actual Primary Completion Date : January 30, 2021
Estimated Study Completion Date : December 2023
Groups and Cohorts
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Group/Cohort
Control group
Patients who are not diagnosed with colorectal adenoma or colorectal cancer
Colorectal adenoma group
Patients who are diagnosed with colorectal adenoma
Colorectal cancer group
Patients who are diagnosed with colorectal cancer


Outcome Measures
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Primary Outcome Measures :
  1. The characteristics of carcinogenesis-related molecular markers in colorectal adenoma and CRC [ Time Frame: through study completion, an average of 1 year ]

    Using endoscopically biopsied specimens, multiple carcinogenic markers were investigated including KRAS and BRAF mutation, PD-L1, EGFR, IL-1b, NLRP3, Caspase-1, p53 expression, Microinstability (MSS, MSI-L, MSI-H), PD-L1, DNA mismatch repair proteins (MLH1, MSH2, MSH6, PMS2), CIMP markers (p16, MINT1, MINT2, MINT31, hMLH1), promoter methylation of p16, RUNX3, NEUROG1.

    CIMP was assessed by methylation-specific PCR for five methylation panel markers (p16, MINT1, MINT2, MINT31, hMLH1), and MSI status was validated by PCR using five NCI markers (BAT-26, BAT-25, D5S346, D17S250, and S2S123). KRAS and BRAF mutation was analyzed by direct sequencing using sequence-specific primers from the acquired biopsy specimens. PD-L1, EGFR, MMR expression was examined using immunohistochemistry.


  2. Fecal microbiota analysis in patients with colorectal adenoma and CRC [ Time Frame: through study completion, an average of 1 year ]
    Using next-generation sequencing technique, fecal microbiota of patients with colorectal adenoma and CRC as well as healthy control was evaluated to verify carcinogenesis-related microbiota.


Biospecimen Retention:   Samples With DNA
Endoscopically biopsied samples, blood samples, fecal samples

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients who visited Seoul National University Bundang Hospital for gastrointestinal symptomes or regular check-ups, and agreed to participate.
Criteria

Inclusion Criteria:

  • Control group: subjects with no evidence of colorectal adenoma or colorectal cancer
  • Colorectal adenoma group: Patients with colorectal adenomas greater than or equal to 10 mm in diameter according to the endoscopic presentation as well as histological validation of colorectal adenoma.
  • Colorectal cancer group: Patients whose biopsy specimen is histologically confirmed as colorectal adenocarcinoma

Exclusion Criteria:

  • Subjects age under 18 years
  • Previous history of colorectal neoplasms
  • Patients with high bleeding risk or patients who must maintain anti-coagulant or anti-platelet agents
  • Denial to participate in this study
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05638542


Locations
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Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Bundang Hospital
Investigators
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Study Chair: Nayoung Kim, M.D., Ph.D Seoul National University Bundang Hospital
More Information
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Responsible Party: Nayoung Kim, Professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT05638542    
Other Study ID Numbers: B-1305-203-009
First Posted: December 6, 2022    Key Record Dates
Last Update Posted: December 6, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nayoung Kim, Seoul National University Bundang Hospital:
Carcinogenesis
Sex difference
Tumor location
Additional relevant MeSH terms:
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Adenoma
Carcinogenesis
Neoplasms
Neoplasms, Glandular and Epithelial
 Neoplasms by Histologic Type
Neoplastic Processes
Pathologic Processes