NCT05601609

Brief Summary

In this study, the investigators compared and evaluated the clinicopathological and oncological characteristics of sporadic colorectal cancer (CRC) in young adults without genetic mutations associated with hereditary CRC syndrome and sporadic CRC in elderly individuals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,599

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

November 11, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2021

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 2, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 19, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 1, 2022

Completed
Last Updated

November 1, 2022

Status Verified

October 1, 2022

Enrollment Period

7 months

First QC Date

October 19, 2022

Last Update Submit

October 31, 2022

Conditions

Keywords

young colorectal cancer patientselderly colorectal cancer patientssporadic colorectal cancer

Outcome Measures

Primary Outcomes (1)

  • Overall survival outcome in young colorectal cancer (yCRC) and elderly colorectal cancer (eCRC)

    The 3-year overall survival (OS) in yCRC and eCRC

    The OS was defined as the time period from the date of surgery to the date of death or last follow-up up to 3 years

Secondary Outcomes (1)

  • Cancer-specific survival outcome in young colorectal cancer (yCRC) and elderly colorectal cancer (eCRC)

    CSS was defined as the time period from the date of surgery to the date of death from CRC up to 3years

Study Arms (2)

young colorectal cancer (yCRC)

1. histologically confirmed cases of adenocarcinoma in the colon and rectum 2. the age at the time of diagnosis should be ≤ 40 years

elderly colorectal cancer (eCRC)

1. histologically confirmed cases of adenocarcinoma in the colon and rectum 2. the age at the time of diagnosis should be ≥ 70 years

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Three tertiary referral hospitals between January 2010 to December 2017

You may qualify if:

  • Histologically confirmed cases of adenocarcinoma in the colon and rectum
  • The age at the time of diagnosis should be ≤ 40 years (for yCRC) or ≥ 70 years (for eCRC)
  • Genetic testing confirmation of non-hereditary cancer.

You may not qualify if:

  • Inflammatory bowel disease
  • A family history of CRC
  • A history of other cancers
  • Underwent any emergency operation or palliative surgery
  • The Amsterdam criteria with mutations in genes associated with APC, MLH1, MSH2, MSH6

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

Related Publications (1)

  • Yang IJ, Kim DW, Lee J, Ahn HM, Oh HK, Kang SB, Suh JW, Kim MH, Oh HJ, Kim HK, Kim MJ, Park JW, Ryoo SB, Park KJ, Jeong SY, Oh JH. Are sporadic colorectal cancers in young patients distinct from those in elderly patients? Colorectal Dis. 2024 Jul;26(7):1405-1414. doi: 10.1111/codi.17072. Epub 2024 Jun 16.

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Duck-Woo Kim, MD PhD

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2022

First Posted

November 1, 2022

Study Start

November 11, 2020

Primary Completion

June 10, 2021

Study Completion

August 2, 2022

Last Updated

November 1, 2022

Record last verified: 2022-10

Locations