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出境医 / 临床实验 / Prognostic Biomarker for CRC (PROMOTE)

Prognostic Biomarker for CRC (PROMOTE)

Study Description
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.

Study Design
Layout table for study information
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
Arms and Interventions
Outcome Measures
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

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:   No
Sampling Method:   Probability Sample
Study Population
Patients with newly histologically confirmed colorectal cancer and no evidence of distant metastasis
Criteria

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
Contacts and Locations

Contacts
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Contact: Ping Lan, PhD 86-20-38254009 sumslp@163.com

Locations
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China
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
Tracking Information
First Submitted Date April 24, 2019
First Posted Date April 26, 2019
Last Update Posted Date April 26, 2019
Actual Study Start Date April 24, 2019
Estimated Primary Completion Date April 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 24, 2019)
  • Failure-free Survival [ Time Frame: 3 years ]
  • Tumor regression grade [ Time Frame: 1 year ]
    For rectal cancer patients who receive neoadjuvant treatment
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: April 24, 2019) 		Overall survival [ Time Frame: 3 years ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prognostic Biomarker for CRC
Official Title Prospective Study for Prognostic And Predictive Biomarkers of Colorectal Cancer
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.
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Whole blood and tumor tissue
Sampling Method Probability Sample
Study Population Patients with newly histologically confirmed colorectal cancer and no evidence of distant metastasis
Condition Colorectal Cancer
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 24, 2019) 		1050
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2023
Estimated Primary Completion Date April 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Ping Lan, PhD 86-20-38254009 sumslp@163.com
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03928652
Other Study ID Numbers Lan2019/4/24
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Sixth Affiliated Hospital, Sun Yat-sen University
Study Sponsor Sixth Affiliated Hospital, Sun Yat-sen University
Collaborators Not Provided
Investigators Not Provided
PRS Account Sixth Affiliated Hospital, Sun Yat-sen University
Verification Date April 2019

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