The Comparison Between Computed Tomography and Colonoscope in Detecting Colorectal Tumors in Patients With FIT+ (CTOCOCREC)

February 28, 2024 updated by: Arunchai Chang, Hat Yai Medical Education Center

The Comparison of Diagnostic Yield Between Routine Computed Tomography and Colonoscope in Detecting Colorectal Tumors in Patients Who at Risk of Colorectal Cancer

Colonoscopy is the mainstay modality of choice in colorectal cancer screening worldwide. However, the rate of colonoscopy for colorectal cancer screening is very low (approximately 5-10%) because of the limited local medical resources (such as endoscopists and regional endoscope). This observational diagnostic test study aims to compare the diagnostic yield of routine computed tomography and colonoscopy in detecting colorectal tumors in patients at risk of colorectal cancer (aged more than 50 years and FIT+). The main question[s] it aims to answer are:

  1. To compare the diagnostic yield between the routine computed tomography and colonoscopy.
  2. To compare the procedure-related adverse events between the routine computed tomography and colonoscopy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

All enrolled patients underwent routine CT scans of whole abdomen, then subsequently under went a colonoscopy on the next day

Study Type

Observational

Enrollment (Estimated)

241

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Thailand
    • Songkhla
      • Hat Yai, Songkhla, Thailand, 90110
        • Recruiting
        • Hatyai Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patients aged 50-70 years old who underwent FIT test for an indication of colorectal cancer screening as National program of Thailand.

Description

Inclusion Criteria:

  1. Fit test +
  2. Normal platelet count and normal result of PT, PTT

Exclusion Criteria:

  1. pregnancy or lactation
  2. uncontrolled Diabetes Mellitus, hypertension, asthma, congestive heart failure
  3. recent coronary artery disease within 3 months
  4. eGFR lesser than 30 mL/min/1.73m2
  5. hemophilia or uncontrolled or uncorrected coagulopathy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort1
Patients with aged more than 50 years and had FIT test +
Diagnostic test: CT and colonoscopy
All patients were admitted and worked up as inpatient cases. A blood test was obtained and a CT whole abdomen was performed for all patients in the evening. On the next day, all patients were prescribed for bowel preparation in the morning, then subsequently underwent colonoscopy in the afternoon.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic yield in diagnosis colorectal tumor
Time Frame: 2 weeks
Sensitivity, specitivity, accuracy
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedure-related adverse events
Time Frame: 2 weeks
Procedure-related adverse events such as, contrast induced nephropathy, contrast allergy, colonoscope-related perforation, post polypectomy bleeding
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hat Yai Medical Education Center

Collaborators

HatYai Hospital

Investigators

  • Principal Investigator: Arunchai Chang, MD, Division of Gastroenetrology, Department of Internal Medicine, Hatyai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

December 2, 2023

First Submitted That Met QC Criteria

December 2, 2023

First Posted (Actual)

December 11, 2023

Study Record Updates

Last Update Posted (Actual)

February 29, 2024

Last Update Submitted That Met QC Criteria

February 28, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HYH EC 093-66-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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