Colonic PolypsJANCTNCT00997802
Japanese National Computed Tomographic (CT) Colonography Trial
A study testing CT colonography and optical colonoscopy in people with Colonic Polyps and Colonic Neoplasms, run by Japanese CT Colonography Society at 12 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the sensitivity of computed tomographic colonography (CTC) in detecting colorectal polyps and cancers in 1,500 subjects at increased risk of colorectal cancer (CRC), using optical colonoscopy as the reference standard. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Colonic Polyps, Colonic Neoplasms
- What is being tested?
- CT colonography and optical colonoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,257 participants
- Where
- 12 sitesin 2 countries
- Study dates
- Oct 2009to Jan 2017
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatients who are eligible for optical colonoscopy.
- Aged 20 years or older.
- Major functions of organs of the subjects are in a good condition.
- Signed informed consent forms are obtained from the patients.
Who cannot join
- Known colorectal polyps or cancers at any site at the time of enrollment.
- Patients with inflammatory bowel disease.
- Fulfillment of clinical criteria for diagnosis of FAP or HNPCC (Amsterdam criteria).
- Serious medical conditions that may increase the risk of optical colonoscopy or are so severe that screening would have no benefit.
- Previous colorectal surgery.
- Gastric or intestinal stenosis, abdominal adhesions, bowel obstruction or perforation, toxic megacolon.
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- Evidence of an increased risk in carrying out bowel preparation or CTC exams.
- Possibility of pregnancy.
- Optical colonoscopy or barium enema carried out within the last 3 years.
- Patients with psychological conditions that contraindicate colonoscopy or that make them irrelevant to participate in the trial.
- Iodine hypersensitivity.
- Severe thyroid disease.
- Claustrophobia.
- Severe deafness.
- Subjects whose eligibility for this clinical trial is not appropriate by other reasons.
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
Japan11 sites
Tokyo Women's Medical University Medical Center East
Arakawa-ku, Tokyo, 116-8567
Hamamatsu South Hospital
Hamamatsu, Shizuoka, 430-0846
Kamigoto Hospital
Kamigotō, Nagasaki, 857-4404
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, 920-8641
Kawasaki Medical School
Kurashiki, Okayama-ken, 701-0192
Otarukyokai Hospital
Otaru, Hokkaido, 047-8510
Tonan Hospital
Sapporo, Hokkaido, 060-0001
Hokkaido Social Insurance Hospital
Sapporo, Hokkaido, 062-8618
Hokkaido Gastroenterology Hospital
Sapporo, Hokkaido, 065-0041
Jichi Medical University Hospital
Shimono, Tochigi, 329-0498
Showa University Northern Yokohama Hospital
Yokohama, Kanagawa, 224-8503
United States1 site
Japanese CTC Society, 3D imaging Laboratory, Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Evaluation of Accuracy of Computed Tomographic Colonography (CTC) in the Diagnosis of Colorectal Tumors by Gastroenterologists and Radiologists With Computer-aided Detection (CAD): A Multicenter Study
The purpose of this study is to evaluate the sensitivity of computed tomographic colonography (CTC) in detecting colorectal polyps and cancers in 1,500 subjects at increased risk of colorectal cancer (CRC), using optical colonoscopy as the reference standard.
Read the detailed description
The investigators will evaluate the sensitivity of CTC in detecting colorectal polyps and cancers (at least 6 mm in diameter) in 1,500 subjects at increased risk of colorectal cancer (CRC), using optical colonoscopy as the reference standard. The primary endpoint will be sensitivity in the detection of colorectal polyps and cancers that are at least 6 mm in diameter. The secondary endpoints will include specificity and predictive values in the detection of colorectal polyps and cancers.
This clinical study will also evaluate the differences of the detection accuracies between human readings with and without computer-aided detection (CAD) that automatically detects colonic lesions in CTC images and presents the detected lesions to the readers. This clinical study will also compare performance between radiologists and gastroenterologists in detecting colorectal lesions in CTC images.
All the CTC images and their interpretations, optical colonoscopy reports and images, and pathology reports of resected colorectal lesion will be prospectively collected from 12 Japanese hospitals participating in the trial. All patients' information will be completely anonymized at each site before any analysis of the data takes place.
- Conditions
- Colonic Polyps, Colonic Neoplasms
- Being tested
- CT colonography and optical colonoscopy
- Keywords
- Computed Tomographic Colonography, Colonic Polyps, Colonic Neoplasms, Computer Aided Diagnosis
- Medical subject headings
- Colonic Polyps, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT colonography and optical colonoscopyDevice
All patients will undergo CT colonography and optical colonoscopy.
| Study group | Role | What they receive |
|---|---|---|
| CT colonography and optical colonoscopy | Other | Not described Receives: Device: CT colonography and optical colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensitivity in the detection of colorectal polyps and cancers in CTC
Measured: 1.5 years
Secondary outcomes (1)
specificity and predictive values in the detection of colorectal polyps and cancers in CTC.
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2009 (estimated)
- Study startOct 2009
- Primary completion11 Dec 2015
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colonic PolypsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,257 participants (actual)
Sponsor and investigators
- Lead sponsor
- Japanese CT Colonography Society
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hiroyuki Yoshida, Japanese CT Colonography Society
- Investigators
- Koichi Nagata, MD, PhD, Study director, Japanese CTC Society
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00997802
- Sponsor's protocol ID
- UMIN000002097
- Acronym
- JANCT
- Status last verified
- Mar 2017
- First submitted
- 18 Oct 2009
- Last updated
- 17 Mar 2017
- Results posted
- No
Publications
Nagata K, Endo S, Honda T, Yasuda T, Hirayama M, Takahashi S, Kato T, Horita S, Furuya K, Kasai K, Matsumoto H, Kimura Y, Utano K, Sugimoto H, Kato H, Yamada R, Yamamichi J, Shimamoto T, Ryu Y, Matsui O, Kondo H, Doi A, Abe T, Yamano HO, Takeuchi K, Hanai H, Saida Y, Fukuda K, Nappi J, Yoshida H. Accuracy of CT Colonography for Detection of Polypoid and Nonpolypoid Neoplasia by Gastroenterologists and Radiologists: A Nationwide Multicenter Study in Japan. Am J Gastroenterol. 2017 Jan;112(1):163-171. doi: 10.1038/ajg.2016.478. Epub 2016 Oct 25.
PubMed 27779195
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Accuracy of Computed Tomographic Colonography (CTC) in the Diagnosis of Colorectal Tumors by Gastroenterologists and Radiologists With Computer-aided Detection (CAD): A Multicenter Study
- ClinicalTrials.gov ID
- NCT00997802
- Acronym / sponsor ID
- JANCT / UMIN000002097
- Conditions
- Colonic Polyps, Colonic Neoplasms
- Keywords
- Computed Tomographic Colonography, Colonic Polyps, Colonic Neoplasms, Computer Aided Diagnosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,257 participants (actual)
- Lead sponsor
- Japanese CT Colonography SocietyUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- 11 Dec 2015 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 19 Oct 2009 (estimated)
- 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.
The purpose of this study is to evaluate the sensitivity of computed tomographic colonography (CTC) in detecting colorectal polyps and cancers in 1,500 subjects at increased risk of colorectal cancer (CRC), using optical colonoscopy as the reference standard.
Detailed description
The investigators will evaluate the sensitivity of CTC in detecting colorectal polyps and cancers (at least 6 mm in diameter) in 1,500 subjects at increased risk of colorectal cancer (CRC), using optical colonoscopy as the reference standard. The primary endpoint will be sensitivity in the detection of colorectal polyps and cancers that are at least 6 mm in diameter. The secondary endpoints will include specificity and predictive values in the detection of colorectal polyps and cancers.
This clinical study will also evaluate the differences of the detection accuracies between human readings with and without computer-aided detection (CAD) that automatically detects colonic lesions in CTC images and presents the detected lesions to the readers. This clinical study will also compare performance between radiologists and gastroenterologists in detecting colorectal lesions in CTC images.
All the CTC images and their interpretations, optical colonoscopy reports and images, and pathology reports of resected colorectal lesion will be prospectively collected from 12 Japanese hospitals participating in the trial. All patients' information will be completely anonymized at each site before any analysis of the data takes place.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CT colonography and optical colonoscopy | Other | Device: CT colonography and optical colonoscopy |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Outpatients who are eligible for optical colonoscopy.
- Aged 20 years or older.
- Major functions of organs of the subjects are in a good condition.
- Signed informed consent forms are obtained from the patients.
Key exclusion criteria (15 listed)
- Known colorectal polyps or cancers at any site at the time of enrollment.
- Patients with inflammatory bowel disease.
- Fulfillment of clinical criteria for diagnosis of FAP or HNPCC (Amsterdam criteria).
- Serious medical conditions that may increase the risk of optical colonoscopy or are so severe that screening would have no benefit.
- Previous colorectal surgery.
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 colonography and optical colonoscopyAll patients will undergo CT colonography and optical colonoscopy. | Device | CT colonography and optical colonoscopy |
Primary outcome
sensitivity in the detection of colorectal polyps and cancers in CTC
Time frame: 1.5 years
1 secondary outcome
specificity and predictive values in the detection of colorectal polyps and cancers in CTC.
Time frame: 1.5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2017.
- Results publication: PubMed 27779195Nagata K, Endo S, Honda T, Yasuda T, Hirayama M, Takahashi S, Kato T, Horita S, Furuya K, Kasai K, Matsumoto H, Kimura Y, Utano K, Sugimoto H, Kato H, Yamada R, Yamamichi J, Shimamoto T, Ryu Y, Matsui O, Kondo H, Doi A, Abe T, Yamano HO, Takeuchi K, Hanai H, Saida Y, Fukuda K, Nappi J, Yoshida H. Accuracy of CT Colonography for Detection of Polypoid and Nonpolypoid Neoplasia by Gastroenterologists and Radiologists: A Nationwide Multicenter Study in Japan. Am J Gastroenterol. 2017 Jan;112(1):163-171. doi: 10.1038/ajg.2016.478. Epub 2016 Oct 25.
- Original ContributionsLink provided by the sponsor.
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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.
Koichi Nagata, MD, PhD study director
Japanese CTC Society
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT colonography and optical colonoscopy in people with Colonic Polyps and Colonic Neoplasms, run by Japanese CT Colonography Society at 12 sites in 2 countries.
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 4 inclusion and 15 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: finished, as of the sponsor's last update on 17 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Japan, United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sensitivity in the detection of colorectal polyps and cancers in CTC (time frame: 1.5 years). 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 NCT00997802, which also lists 1 linked publication.
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 17 Mar 2017.