Are Sporadic Colorectal Cancers in Young Distinct From Elderly?

Colorectal Neoplasms Clinical Trial

Official title:

Are Sporadic Colorectal Cancers in Young Distinct From Elderly?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05601609
• Other study ID #: B-2011/651-103
• Status: Completed
• Start date: November 11, 2020
• Est. completion date: August 2, 2022

Study information

• Verified date: October 2022
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The ambiguity in the findings among several previous studies might be because of the difference in the age of the study population, yCRC and eCRC. The family history of CRC and cancer due to Crohn's disease or ulcerative colitis were also not excluded in such previous studies. Most importantly, those studies did not rule out the risk of hereditary cancer through the genetic testing in yCRC. Since hereditary CRC accounts for approximately 34% of those under the age of 35 years, it is necessary to exclude it to accurately compare the clinicopathological characteristics of sporadic cancer developed in yCRC and eCRC.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1599
• Est. completion date: August 2, 2022
• Est. primary completion date: June 10, 2021
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Colorectal Neoplasms

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital	Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cancer-specific survival outcome in young colorectal cancer (yCRC) and elderly colorectal cancer (eCRC)	The 3-year cancer-specific survival (CSS) in yCRC and eCRC	CSS was defined as the time period from the date of surgery to the date of death from CRC up to 3years