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NCT04287400 Clinical Trial

Prospective Trial for the Evaluation of Radiogenomics in Advanced Rectal Cancer

Rectal Cancer Clinical Trial

Official title:
Prospective Clinical Trial for the Evaluation of Radiogenomics: Correlation, Treatment Response and Prognosis in Patients With Advanced Rectal Cancer, Who Undergo Preoperative Chemoradiation

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04287400
Other study ID # 2018-0428-0001
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 5, 2019
Est. completion date December 1, 2025

Study information
Verified date September 2021
Source National Cancer Center, Korea
Contact DAE KYUNG SOHN
Phone 82319201636
Email gsgsbal@ncc.re.kr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In patients with advanced rectal cancer, molecular subtypes will be identified by preoperative biopsy, CT, MRI / PET radiomics analysis, clinical features, and clinical features will be confirmed and compared. Also, we want to confirm the relationship between these factors and the treatment response after chemoradiotherapy before surgery. The prognosis will be then assessed through 5-year overall survival and 3-year disease free survival. A prospective clinical trial, recruiting 210 persons (approximately 53 per year) that meet the selection criteria for approximately four years from the IRB approval date in 2019 (about 53 per year) We will analyze the data and then collect and analyze the data and report the results.

Recruitment information / eligibility
Status Recruiting
Enrollment 210
Est. completion date December 1, 2025
Est. primary completion date December 1, 2022
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria: - Age: 20-80 years - Patients diagnosed with mid-lower rectal cancer and expected to receive chemoradiotherapy before surgery Exclusion Criteria: - Patients with distal metastases confirmed at diagnosis - Patients with other bowel diseases such as IBD, ischemic colitis and TB colitis in addition to colorectal cancer - If patients do not agree with this study

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of National Cancer Center Goyang-si Gyeonggi-do

Sponsors (1)
Lead Sponsor Collaborator
National Cancer Center, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary K-RAS Mutation K-RAS Mutation status 4 weeks
Secondary Radiomics - MR image findings Radiologic features 4 weeks
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