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OpenTrials
Completed

NCT Number: NCT05601609

Are Sporadic Colorectal Cancers in Young Distinct From Elderly?

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.

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Key information

Conditions

Colorectal Neoplasms Colonic Diseases Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Bundang Hospital

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

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: 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

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

Secondary outcomes

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

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

    The 3-year cancer-specific survival (CSS) in yCRC and eCRC

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Collaborators

  • Seoul National University Hospital

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Nov 1, 2022
Registry last updated
Nov 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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