NCT05832372

Brief Summary

Colorectal cancer (CRC) is the third most diagnosed cancer worldwide and second leading cause of cancer death. Most CRCs arise from a polyp, developing through two major precursor lesion pathways: the traditional adenoma-carcinoma pathway, and the serrated neoplasia pathway. This provides opportunities to prevent cancer by removing its precursor lesions. CRC screening efforts are directed toward removal of precancerous polyps with colonoscopy and detection of early-stage CRC, which has been demonstrated to reduce CRC incidence and mortality effectively, making CRC one of the most preventable and treatable forms of cancer. Current guidelines in China recommend starting CRC screening uniformly at age 50 in average-risk individuals. However, a one-fits-all approach to determining CRC screening starting age may be not conducive to personalized screening, especially in the developing countries with scarce health resources. The incidence of early-onset CRC (CRC diagnosed before the age of 50) has shown a continuous increasing trend worldwide, spurring the US Preventive Services Task Force to recommend initiating average-risk CRC screening at age 45 instead of 50. Furthermore, different populations may benefit from even earlier screening, and CRC incidence may differ on the basis of population characteristics and CRC risk factors. For individuals younger than 50 years old, earlier screening based on risk factors may address this concern. Previous studies have recommended earlier starting age of CRC screening combined with risk factors such as but not limited to sex, age, family history, lifestyle and comorbidity. Some upper gastrointestinal diseases have also been reported to be associated with an increased risk of colorectal neoplasms, which may be related to the destruction of gastric acid barrier function and long-term use of pump proton inhibitors. Compared with colonoscopy examination, individuals were more willing to undergo esophagogastroduodenoscopy (EGD) examination for gastric cancer screening, especially among the younger, potentially utilizing the EGD to guide earlier colonoscopies for patients at increased risk. Therefore, this study was aimed to investigate the association between esophagogastric histopathology and colorectal neoplasms in patients under the age of 50 and whether these risks factor could be combined with to guide earlier CRC screening.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
9,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2023

Shorter than P25 for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

March 27, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 27, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 27, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 27, 2023

Completed
Last Updated

April 27, 2023

Status Verified

April 1, 2023

Enrollment Period

26 days

First QC Date

March 27, 2023

Last Update Submit

April 26, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Prevalence or occurrence of upper gastrointestinal diseases

    Including Helicobacter pylori, atrophic gastritis/intestinal metaplasia, reflux esophagitis, Barrett's esophagus, peptic ulcer, gastric polyps, low-grade intraepithelial neoplasia (LGIN), and high-grade intraepithelial neoplasia (HGIN).

    1 year

Study Arms (2)

Normal colonoscopy group

Individuals with normal colonoscopy examination

Colorectal polyps group

Individuals with colorectal polyps diagnosed by colonoscopy

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

This retrospective observational study analyzed records between November 7, 2020, and November 14, 2022 which were extracted from Qilu Hospital of Shandong University. Patients younger than 50 years old who underwent gastroscopy and colonoscopy simultaneously, were selected and enrolled.

You may qualify if:

  • Patients younger than 50 years old who underwent gastroscopy and colonoscopy simultaneously.

You may not qualify if:

  • Patients without a good bowel preparation (Boston Bowel Preparation Scale \[BBPS\] score ≥ 6);
  • Incomplete gastroscopy or colonoscopy examinations;
  • Partial or total gastrointestinal resection;
  • Patients who have been diagnosed with gastrointestinal cancer before endoscopy;
  • Hereditary polyposis, including Peutz-Jeghers syndrome, and familial adenomatous polyposis;
  • A history of inflammatory bowel diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

First Submitted

March 27, 2023

First Posted

April 27, 2023

Study Start

May 1, 2023

Primary Completion

May 27, 2023

Study Completion

May 27, 2023

Last Updated

April 27, 2023

Record last verified: 2023-04