Patients at Risk of Colorectal CancerCTOCOCRECNCT06165328
The Comparison Between Computed Tomography and Colonoscope in Detecting Colorectal Tumors in Patients With FIT+
An observational study of Patients at Risk of Colorectal Cancer, run by Hat Yai Medical Education Center at 1 site in Thailand.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Patients at Risk of Colorectal Cancer
- What is being tested?
- CT and colonoscopy
- How many people
- 241 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jan 2024to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients aged 50-70 years old who underwent FIT test for an indication of colorectal cancer screening as National program of Thailand.
Who may be able to join
- Fit test +
- Normal platelet count and normal result of PT, PTT
Who cannot join
- pregnancy or lactation
- uncontrolled Diabetes Mellitus, hypertension, asthma, congestive heart failure
- recent coronary artery disease within 3 months
- eGFR lesser than 30 mL/min/1.73m2
- hemophilia or uncontrolled or uncorrected coagulopathy
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Hatyai Hospital
Hat Yai, Changwat Songkhla, 90110
Arunchai Chang, MD, +66650979414, busmdcu58@gmail.com
About this study
Official title: 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:
- To compare the diagnostic yield between the routine computed tomography and colonoscopy.
- To compare the procedure-related adverse events between the routine computed tomography and colonoscopy.
Read the detailed description
All enrolled patients underwent routine CT scans of whole abdomen, then subsequently under went a colonoscopy on the next day
- Conditions
- Patients at Risk of Colorectal Cancer
- Being tested
- CT and colonoscopy
- Keywords
- colorectal tumor, colorectal cancer, CT scan, colonoscopy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT and colonoscopyDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Cohort1 | Patients with aged more than 50 years and had FIT test + Receives: Diagnostic Test: CT and colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic yield in diagnosis colorectal tumor
Sensitivity, specitivity, accuracy
Measured: 2 weeks
Secondary outcomes (1)
Procedure-related adverse events
Procedure-related adverse events such as, contrast induced nephropathy, contrast allergy, colonoscope-related perforation, post polypectomy bleeding
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start1 Jan 2024
- Primary completion1 Nov 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Patients at Risk of Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 241 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hat Yai Medical Education Center
- Sponsor type
- University, hospital or other
- Collaborators
- HatYai Hospital
- Responsible party
- Principal investigator, Arunchai Chang, Hat Yai Medical Education Center
- Investigators
- Arunchai Chang, MD, Principal investigator, Division of Gastroenetrology, Department of Internal Medicine, Hatyai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06165328
- Sponsor's protocol ID
- HYH EC 093-66-01
- Acronym
- CTOCOCREC
- Status last verified
- Feb 2024
- First submitted
- 2 Dec 2023
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shaukat A, Levin TR. Current and future colorectal cancer screening strategies. Nat Rev Gastroenterol Hepatol. 2022 Aug;19(8):521-531. doi: 10.1038/s41575-022-00612-y. Epub 2022 May 3.
PubMed 35505243Wong MCS, Chan FKL. Colorectal cancer screening in middle eastern countries: Current status and future strategies to enhance screening. Saudi J Gastroenterol. 2019 Jan-Feb;25(1):1-2. doi: 10.4103/sjg.SJG_611_18. No abstract available.
PubMed 30665995Tanaka H, Oka S, Shiotani A, Sugimoto M, Suzuki H, Naito Y, Handa O, Hisamatsu T, Fukudo S, Fujishiro M, Motoya S, Yahagi N, Yamaguchi S, Chan FKL, Lee SY, Li B, Ang TL, Abdullah M, Tablante MC, Prachayakul V, Tanaka S; International Gastrointestinal Consensus Symposium Study Group. Current Status of Diagnosis and Treatment of Colorectal Cancer in Asian Countries: A Questionnaire Survey. Digestion. 2024;105(1):62-68. doi: 10.1159/000531706. Epub 2023 Jul 27.
PubMed 37497916Ganeshan A, Upponi S, Uberoi R, D'Costa H, Picking C, Bungay H. Minimal-preparation CT colon in detection of colonic cancer, the Oxford experience. Age Ageing. 2007 Jan;36(1):48-52. doi: 10.1093/ageing/afl116. Epub 2006 Nov 17.
PubMed 17114203Pilleul F, Bansac-Lamblin A, Monneuse O, Dumortier J, Milot L, Valette PJ. Water enema computed tomography: diagnostic tool in suspicion of colorectal tumor. Gastroenterol Clin Biol. 2006 Feb;30(2):231-4. doi: 10.1016/s0399-8320(06)73158-x.
PubMed 16565655Miller J, Maeda Y, Au S, Gunn F, Porteous L, Pattenden R, MacLean P, Noble CL, Glancy S, Dunlop MG, Din FVN. Short-term outcomes of a COVID-adapted triage pathway for colorectal cancer detection. Colorectal Dis. 2021 Jul;23(7):1639-1648. doi: 10.1111/codi.15618. Epub 2021 Mar 29.
PubMed 33682302
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Diagnostic Yield Between Routine Computed Tomography and Colonoscope in Detecting Colorectal Tumors in Patients Who at Risk of Colorectal Cancer
- ClinicalTrials.gov ID
- NCT06165328
- Acronym / sponsor ID
- CTOCOCREC / HYH EC 093-66-01
- Conditions
- Patients at Risk of Colorectal Cancer
- Keywords
- colorectal tumor, colorectal cancer, CT scan, colonoscopy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 241 participants (estimated)
- Lead sponsor
- Hat Yai Medical Education CenterUniversity, hospital or other
- Collaborators
- HatYai Hospital
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 11 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To compare the diagnostic yield between the routine computed tomography and colonoscopy.
- To compare the procedure-related adverse events between the routine computed tomography and colonoscopy.
Detailed description
All enrolled patients underwent routine CT scans of whole abdomen, then subsequently under went a colonoscopy on the next day
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort1 | – | Diagnostic Test: CT and colonoscopyPatients with aged more than 50 years and had FIT test + |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients aged 50-70 years old who underwent FIT test for an indication of colorectal cancer screening as National program of Thailand.
Key inclusion criteria (2 listed)
- Fit test +
- Normal platelet count and normal result of PT, PTT
Key exclusion criteria (5 listed)
- pregnancy or lactation
- uncontrolled Diabetes Mellitus, hypertension, asthma, congestive heart failure
- recent coronary artery disease within 3 months
- eGFR lesser than 30 mL/min/1.73m2
- hemophilia or uncontrolled or uncorrected coagulopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT and colonoscopyAll 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. | Diagnostic test | Cohort1 |
Primary outcome
Diagnostic yield in diagnosis colorectal tumor
Time frame: 2 weeks
Sensitivity, specitivity, accuracy
1 secondary outcome
Procedure-related adverse events
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
- Results publication: PubMed 35505243Shaukat A, Levin TR. Current and future colorectal cancer screening strategies. Nat Rev Gastroenterol Hepatol. 2022 Aug;19(8):521-531. doi: 10.1038/s41575-022-00612-y. Epub 2022 May 3.
- Results publication: PubMed 30665995Wong MCS, Chan FKL. Colorectal cancer screening in middle eastern countries: Current status and future strategies to enhance screening. Saudi J Gastroenterol. 2019 Jan-Feb;25(1):1-2. doi: 10.4103/sjg.SJG_611_18. No abstract available.
- Results publication: PubMed 37497916Tanaka H, Oka S, Shiotani A, Sugimoto M, Suzuki H, Naito Y, Handa O, Hisamatsu T, Fukudo S, Fujishiro M, Motoya S, Yahagi N, Yamaguchi S, Chan FKL, Lee SY, Li B, Ang TL, Abdullah M, Tablante MC, Prachayakul V, Tanaka S; International Gastrointestinal Consensus Symposium Study Group. Current Status of Diagnosis and Treatment of Colorectal Cancer in Asian Countries: A Questionnaire Survey. Digestion. 2024;105(1):62-68. doi: 10.1159/000531706. Epub 2023 Jul 27.
- Results publication: PubMed 17114203Ganeshan A, Upponi S, Uberoi R, D'Costa H, Picking C, Bungay H. Minimal-preparation CT colon in detection of colonic cancer, the Oxford experience. Age Ageing. 2007 Jan;36(1):48-52. doi: 10.1093/ageing/afl116. Epub 2006 Nov 17.
- Results publication: PubMed 16565655Pilleul F, Bansac-Lamblin A, Monneuse O, Dumortier J, Milot L, Valette PJ. Water enema computed tomography: diagnostic tool in suspicion of colorectal tumor. Gastroenterol Clin Biol. 2006 Feb;30(2):231-4. doi: 10.1016/s0399-8320(06)73158-x.
- Results publication: PubMed 33682302Miller J, Maeda Y, Au S, Gunn F, Porteous L, Pattenden R, MacLean P, Noble CL, Glancy S, Dunlop MG, Din FVN. Short-term outcomes of a COVID-adapted triage pathway for colorectal cancer detection. Colorectal Dis. 2021 Jul;23(7):1639-1648. doi: 10.1111/codi.15618. Epub 2021 Mar 29.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arunchai Chang, MD principal investigator
Division of Gastroenetrology, Department of Internal Medicine, Hatyai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients at Risk of Colorectal Cancer, run by Hat Yai Medical Education Center at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arunchai Chang, MD (+66650979414, busmdcu58@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic yield in diagnosis colorectal tumor (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06165328, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2024.