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

Application of Radiomics in Precise Preoperative Diagnosis and Prognsis Evaluation of Colorectal Cancer: a Prospective, Clinical Study

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.

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer Stage I-IV
• Intervention / Treatment: Diagnostic test: CT or MRI based Radiomics

• Study Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

• Study Contact: Name: Guoxiang Cai, M.D.Ph.D.; Phone Number: +86 13611831623; Email: gxcai@fudan.edu.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Fudan University Shanghai Cancer Center
      • Contact: Guoxiang Cai; Phone Number: +8613611831623 +8613611831623; Email: gxcai@fudan.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients received enhaced CT or MRI test must have baseline evaluations performed prior to the study and must meet all inclusion and exclusion criteria. In addition, the patient must be thoroughly informed about all aspects of the study, including the study visit schedule and required evaluations and all regulatory requirements for informed consent.

Description

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

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with pathologically diagnosed colorectal cancer	Diagnostic test: CT or MRI based Radiomics; Radiomic features were extracted from enhanced CT or MRI of colorectal cancer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity	The sensitivity of radiomics in predicting regional or distant synchronous colorectal metastasis	2 years

Collaborators and Investigators

• Sponsor: Fudan University

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2018
• Primary Completion (ANTICIPATED): December 31, 2019
• Study Completion (ANTICIPATED): December 31, 2020

Study Registration Dates

• First Submitted: December 22, 2018
• First Submitted That Met QC Criteria: December 22, 2018
• First Posted (ACTUAL): December 26, 2018

Study Record Updates

• Last Update Posted (ACTUAL): December 26, 2018
• Last Update Submitted That Met QC Criteria: December 22, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: ColoRadiomics

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No