NCT05365412

Brief Summary

A Study on the Characteristics of Colorectal Cancer by Age and sex.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,400

participants targeted

Target at P75+ for all trials

Timeline
7mo left

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
Jan 2019Dec 2026

Study Start

First participant enrolled

January 1, 2019

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

April 24, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 9, 2022

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

7.8 years

First QC Date

April 24, 2022

Last Update Submit

April 23, 2026

Conditions

Keywords

colorectal cancerprognosissex difference

Outcome Measures

Primary Outcomes (1)

  • Survival (overall/disease-specific) according to sex, molecular profiles and sex hormone receptors

    Time from diagnosis to death

    From date of enrollment until the date of death from colorectal cancer or from any cause, assessed up to 120 months

Secondary Outcomes (1)

  • Disease-free survival according to sex, molecular profiles and sex hormone receptors

    From date of enrollment until the date of first documented recurrence of colorectal cancer, assessed up to 120 months

Study Arms (1)

Colorectal cancer group

Patients treated after being diagnosed with colorectal cancer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients treated after being diagnosed with colorectal cancer, and agreed to participate

You may qualify if:

  • Patients treated after being diagnosed with colorectal cancer

You may not qualify if:

  • Patients under age of 18 years, or patients who cannot choose whether to participate or not
  • Patients who refuse to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Microinstability (MSS, MSI-L, MSI-H), DNA mismatch repair genes (hMLH1, hMSH2, hMSH6, hPMS2), RAS genes (KRAS, NRAS, HRAS), BRAF mutations from cancer tissue will be analyzed using immunohistochemistry (IHC) and reverse transcriptase polymerase chain reaction (RT-PCR). In addition, the expression of estrogen and androgen receptors will further be analyzed in each patient.

MeSH Terms

Conditions

Colonic NeoplasmsColorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Nayoung Kim, MD, PhD

    Seoul National University Bundang Hospital

    STUDY CHAIR

Central Study Contacts

Nayoung Kim, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 24, 2022

First Posted

May 9, 2022

Study Start

January 1, 2019

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

April 28, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations