Prognostic Biomarker for CRC

NCT ID: NCT03928652

Last Updated: 2019-04-26

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

UNKNOWN

Total Enrollment

1050 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-24

Study Completion Date

2023-12-31

Brief Summary

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The purpose of this clinical research project is to explore potential biomarkers and validate the predictive and prognostic value of molecular signature in colorectal cancer.

Detailed Description

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This is a prospective observational study. Tumor tissue specimens and surgical specimens are obtained from the Sixth Affiliated Hospital, Sun Yat-sen University. The samples are analyzed for biomarkers. The biomarkers are correlated with clinical outcomes (failure-free survival, overall survival, tumor response to treatment (e.g. tumor regression grade for rectal cancer), distant metastasis, recurrence and death).

The aim of the analysis is to explore potential biomarkers and validate the predictive and prognostic value of molecular signature in . This will lead to the definition of risk groups and stratification of patients and will help to precision medicine of colorectal cancer.

Conditions

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Colorectal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

1. Colon or rectal cancer diagnosed by endoscopic biopsy histopathology;
2. Complete sample information, including sample number, gender, age and clinical molecular diagnostic information, etc.;
3. Sufficient surgical tissue samples are available for testing;
4. untreated colon or rectal cancer patients;
5. Patient able to understand and sign written informed consent
6. No evidence of distant metastasis (M0)

Exclusion Criteria

1. Previously treated CRC, including cytotoxic drug therapy, targeted drug therapy, etc.;
2. Other malignant tumors;
3. Pregnant women;
4. Hereditary colorectal cancer linked to familial colonic polyposis or Lynch syndrome
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sixth Affiliated Hospital, Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Sixth Affiliated Hospital, Sun Yet-sen University

Guangzhou, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ping Lan, PhD

Role: CONTACT

86-20-38254009

Facility Contacts

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Ping Lan, MD, PhD

Role: primary

Other Identifiers

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Lan2019/4/24

Identifier Type: -

Identifier Source: org_study_id

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