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Prognostic Biomarker for CRC (PROMOTE)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03928652
Recruitment Status : Recruiting
First Posted : April 26, 2019
Last Update Posted : April 26, 2019
Information provided by (Responsible Party):
Sixth Affiliated Hospital, Sun Yat-sen University

Brief Summary:
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.

Condition or disease
Colorectal Cancer

Detailed Description:

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.

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Study Type : Observational
Estimated Enrollment : 1050 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Study for Prognostic And Predictive Biomarkers of Colorectal Cancer
Actual Study Start Date : April 24, 2019
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : December 2023

Primary Outcome Measures :
  1. Failure-free Survival [ Time Frame: 3 years ]
  2. Tumor regression grade [ Time Frame: 1 year ]
    For rectal cancer patients who receive neoadjuvant treatment

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 3 years ]

Biospecimen Retention:   Samples With DNA
Whole blood and tumor tissue

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with newly histologically confirmed colorectal cancer and no evidence of distant metastasis

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

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 identifier (NCT number): NCT03928652

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Contact: Ping Lan, PhD 86-20-38254009

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The Sixth Affiliated Hospital, Sun Yet-sen University Recruiting
Guangzhou, China
Contact: Ping Lan, MD, PhD         
Sponsors and Collaborators
Sixth Affiliated Hospital, Sun Yat-sen University
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Responsible Party: Sixth Affiliated Hospital, Sun Yat-sen University Identifier: NCT03928652    
Other Study ID Numbers: Lan2019/4/24
First Posted: April 26, 2019    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases