Application of Radiomics in Precise Preoperative Diagnosis and Prognsis Evaluation of Colorectal Cancer.

• Conditions: Colorectal Cancer Stage I-IV
• Interventions: Diagnostic Test: CT or MRI based Radiomics

• Registration Number: NCT03787667
• Lead Sponsor: Fudan University

Brief Summary

This is a prospective, clinical study. This study is to collect and analyze data of radiomics of primary site or metastasis of colorectal cancer aiming to precisizing preoperative diagnosis and long-term prognsis evaluation.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-05-01
• Status Verified: 2018-12
• Study First Submitted: 2018-12-22
• Study First Submitted QC: 2018-12-22
• Last Update Submitted: 2018-12-22
• Study First Posted: 2018-12-26
• Last Update Posted: 2018-12-26
• Primary Completion: 2019-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

• Patients with pathologically confirmed colorectal cancer
• Male or female aged 18-75 years old on the day of signing informed consent.
• Patients who received imageological examination of primary or metastasis
• Patients who received surgical resection of primary or metastasis
• Patients must have a performance status of ≤1 on the ECOG Performance Scale.
• Colorectal cancer is the only malignant tumor
• Written informed consent must be obtained from patient or patient's legal representative and ability for patient to comply with the requirements of the study

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Exclusion Criteria

• Patients received adjuvant treatment prior to imageological examination
• Tis stage patients
• Paitents who diagnosed with malignant disease within 5 years.
• Patients with a history or current evidence of any condition or abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the Investigator.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with pathologically diagnosed colorectal cancer	CT or MRI based Radiomics	Patients with pathologically diagnosed colorectal cancer

Primary Outcome Measures

Name	Time	Method
Sensitivity	2 years	The sensitivity of radiomics in predicting regional or distant synchronous colorectal metastasis

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China