Colorectal NeoplasmsNCT03604237
Targeted Forceps Biopsy for Colorectal Tumors
A study testing Targeted group in people with Colorectal Neoplasms, run by Kyungpook National University Hospital at 1 site in South Korea.
Trial summary
This study evaluates whether targeted forceps biopsy with careful tumor surface evaluation can improve diagnostic accuracy of colorectal tumors larger than 2 cm during colonoscopy. Read more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- Targeted group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Sep 2017to 1 Oct 2018
- Phase
- Interventional
- 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 19 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with colorectal neoplasms of the size larger than 2 cm
Who cannot join
- Patients who deny the participation in the study
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Kyungpook National University Hospital
Daegu, 41944
Eun Soo Kim, MD, PhD, +82-53-200-5879, dandy813@hanmail.net
About this study
Official title: Concordance Rate of Pathology Between Targeted Forceps Biopsy and Resected Specimen for Large Colorectal Tumors
This study evaluates whether targeted forceps biopsy with careful tumor surface evaluation can improve diagnostic accuracy of colorectal tumors larger than 2 cm during colonoscopy.
- Conditions
- Colorectal Neoplasms
- Being tested
- Targeted group
- Keywords
- forceps biopsy, colorectal tumors
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted groupDiagnostic test
Forceps biopsy is taken after surface evaluation of the large colorectal tumors.
| Study group | Role | What they receive |
|---|---|---|
| Targeted forceps biopsy | Experimental | In this group, an endoscopist takes a forceps biopsy at depressed mucosa or large nodular area of large colorectal tumors after meticulous surface evaluation. Receives: Diagnostic Test: Targeted group |
| Conventional forceps biopsy | No intervention | In this group, an endoscopist takes a forceps biopsy at the most convenient area of large colorectal tumors. |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathologic diagnosis
The pathologic diagnosis of forceps biopsy is compared with the pathologic diagnosis of resected specimen of the colorectal tumor.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study start1 Sep 2017
- Primary completion1 Aug 2018 (estimated)
- Study completion1 Oct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyungpook National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eun Soo Kim, MD, PhD, Kyungpook National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03604237
- Sponsor's protocol ID
- KNUH201804
- Status last verified
- Jul 2018
- First submitted
- 19 Jul 2018
- Last updated
- 27 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concordance Rate of Pathology Between Targeted Forceps Biopsy and Resected Specimen for Large Colorectal Tumors
- ClinicalTrials.gov ID
- NCT03604237
- Acronym / sponsor ID
- KNUH201804
- Conditions
- Colorectal Neoplasms
- Keywords
- forceps biopsy, colorectal tumors
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Kyungpook National University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Aug 2018 (estimated)
- Study completion
- 1 Oct 2018 (estimated)
- First posted
- 27 Jul 2018 (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.
This study evaluates whether targeted forceps biopsy with careful tumor surface evaluation can improve diagnostic accuracy of colorectal tumors larger than 2 cm during colonoscopy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Targeted forceps biopsy | Experimental | Diagnostic Test: Targeted groupIn this group, an endoscopist takes a forceps biopsy at depressed mucosa or large nodular area of large colorectal tumors after meticulous surface evaluation. |
| Conventional forceps biopsy | No intervention | –In this group, an endoscopist takes a forceps biopsy at the most convenient area of large colorectal tumors. |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with colorectal neoplasms of the size larger than 2 cm
Key exclusion criteria (1 listed)
- Patients who deny the participation in the study
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 |
|---|---|---|
| Targeted groupForceps biopsy is taken after surface evaluation of the large colorectal tumors. | Diagnostic test | Targeted forceps biopsy |
Primary outcome
pathologic diagnosis
Time frame: 7 days
The pathologic diagnosis of forceps biopsy is compared with the pathologic diagnosis of resected specimen of the colorectal tumor.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2018.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Targeted group in people with Colorectal Neoplasms, run by Kyungpook National University Hospital at 1 site in South Korea.
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 1 inclusion and 1 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 27 Jul 2018. 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 South Korea. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pathologic diagnosis (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jul 2018.