Prognostic Biomarker for CRC

Prospective Study for Prognostic And Predictive Biomarkers of Colorectal Cancer

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03928652

Acronym

PROMOTE

Enrollment

1050

Registered

2019-04-26

Start date

2019-04-24

Completion date

2023-12-31

Last updated

2019-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Failure-free Survival	3 years	—
Tumor regression grade	1 year	For rectal cancer patients who receive neoadjuvant treatment

Secondary

Measure	Time frame
Overall survival	3 years

Countries

China

Contacts

Primary ContactPing Lan, PhD

sumslp@163.com86-20-38254009

Outcome results