Prospective Trial for the Evaluation of Radiogenomics in Advanced Rectal Cancer

NCT ID: NCT04287400

Last Updated: 2021-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

210 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-05

Study Completion Date

2025-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Rectal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Center, Korea

OTHER_GOV

Sponsor Role lead

Responsible Party

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Dae Kyung Sohn

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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National Cancer Center

Goyang-si, Gyeonggi-do, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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DAE KYUNG SOHN

Role: CONTACT

82319201636

Dae Sohn

Role: CONTACT

82319201282

Facility Contacts

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Dae Kyung Sohn, MD,PHD

Role: primary

+82-31-920-1636

Dae Kyung Sohn

Role: backup

+82-31-920-1761

Other Identifiers

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2018-0428-0001

Identifier Type: -

Identifier Source: org_study_id

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