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Prospective Trial for the Evaluation of Radiogenomics in Advanced Rectal Cancer

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04287400
Enrollment
210
Registered
2020-02-27
Start date
2019-03-05
Completion date
2025-12-01
Last updated
2021-09-05

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

Conditions

Rectal Cancer

Brief 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.

Interventions

None listed

Sponsors

National Cancer Center, Korea
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
K-RAS Mutation4 weeksK-RAS Mutation status

Secondary

MeasureTime frameDescription
Radiomics - MR image findings4 weeksRadiologic features

Countries

South Korea

Contacts

Primary ContactDAE KYUNG SOHN
gsgsbal@ncc.re.kr82319201636
Backup ContactDae Sohn
gsgsbal@gmail.com82319201282

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026