UMIN-CTR Clinical Trial
| Recruitment status | Completed |
| Unique ID issued by UMIN | UMIN000012116 |
| Receipt No. | R000014168 |
| Scientific Title | The comparative study of fecal immunochemical test-positive and negative colorectal tumors in opportunistic screening |
| Date of disclosure of the study information | 2013/10/25 |
| Last modified on | 2019/08/16 (Ver. 7) |
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| Basic information | ||
| Public title | The comparative study of fecal immunochemical test-positive and negative colorectal tumors in opportunistic screening | |
| Acronym | The comparative study of FIT-positive and negative colorectal tumors in opportunistic screening | |
| Scientific Title | The comparative study of fecal immunochemical test-positive and negative colorectal tumors in opportunistic screening | |
| Scientific Title:Acronym | The comparative study of FIT-positive and negative colorectal tumors in opportunistic screening | |
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| Condition | |||
| Condition | colorectal tumors | ||
| Classification by specialty |
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| Classification by malignancy | Malignancy | ||
| Genomic information | NO | ||
| Objectives | |
| Narrative objectives1 | To clarify the endoscopic features of CRCs with false-negative fecal immunochemical test (FIT) in asymptomatic examinees of opportunistic screening in our hospital. |
| Basic objectives2 | Others |
| Basic objectives -Others | To evaluate the characteristics of FIT-negative colorectal cancers against FIT-positive ones. |
| Trial characteristics_1 | Confirmatory |
| Trial characteristics_2 | Pragmatic |
| Developmental phase | Not applicable |
| Assessment | |
| Primary outcomes | diameter, morphology, invation depth and presence of lymph node metastases of the colorectal cancer |
| Key secondary outcomes | age, gender, prevalence rate, rate of symptomatic examinees, rate of invasive cancer of colorectal tumor |
| Base | |
| Study type | Interventional |
| Study design | |
| Basic design | Parallel |
| Randomization | Non-randomized |
| Randomization unit | |
| Blinding | Open -no one is blinded |
| Control | Active |
| Stratification | |
| Dynamic allocation | |
| Institution consideration | |
| Blocking | |
| Concealment | |
| Intervention | ||
| No. of arms | 2 | |
| Purpose of intervention | Prevention | |
| Type of intervention |
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| Interventions/Control_1 | The FIT-negative examinee | |
| Interventions/Control_2 | The FIT-positive examinee | |
| Interventions/Control_3 | ||
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| Interventions/Control_6 | ||
| Interventions/Control_7 | ||
| Interventions/Control_8 | ||
| Interventions/Control_9 | ||
| Interventions/Control_10 | ||
| Eligibility | ||||
| Age-lower limit |
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| Age-upper limit |
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| Gender | Male and Female | |||
| Key inclusion criteria | The examinee who recieved FIT in our oppotunistic screening. | |||
| Key exclusion criteria | The examinee who did not recieve a colonoscopy in our hospital. | |||
| Target sample size | 2200 | |||
| Research contact person | |||||||
| Name of lead principal investigator |
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| Organization | Showa University Northern Yokohama Hospital | ||||||
| Division name | Digestive Disease Center | ||||||
| Zip code | 2248503 | ||||||
| Address | Chigasaki-chuo 35-1 Tsuzuki-ku, Yokohama, 224-503, Japan | ||||||
| TEL | 0459497000 | ||||||
| kudos@med.showa-u.ac.jp | |||||||
| Public contact | |||||||
| Name of contact person |
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| Organization | Showa University Northern Yokohama Hospital | ||||||
| Division name | Digestive Disease Center | ||||||
| Zip code | 2248503 | ||||||
| Address | Chigasaki-chuo 35-1 Tsuzuki-ku, Yokohama, 224-503, Japan | ||||||
| TEL | 045(949)7000 | ||||||
| Homepage URL | |||||||
| wakamura92@hkg.odn.ne.jp | |||||||
| Sponsor | |
| Institute | Digestive Disease Center , Showa University Northern Yokohama Hospital |
| Institute | |
| Department | |
| Funding Source | |
| Organization | None. |
| Organization | |
| Division | |
| Category of Funding Organization | Self funding |
| Nationality of Funding Organization | |
| Other related organizations | |
| Co-sponsor | |
| Name of secondary funder(s) | |
| IRB Contact (For public release) | |
| Organization | Institutional review board, Showa University Northern Yokohama Hospital |
| Address | Chigasaki-chuo 35-1 Tsuzuki-ku, Yokohama, 224-503, Japan |
| Tel | 045(949)7175 |
| fjtcrc@cmed.showa-u.ac.jp | |
| Secondary IDs | |
| Secondary IDs | NO |
| Study ID_1 | |
| Org. issuing International ID_1 | |
| Study ID_2 | |
| Org. issuing International ID_2 | |
| IND to MHLW | |
| Institutions | |
| Institutions | 昭和大学横浜市北部病院消化器センター（神奈川県） |
| Other administrative information | |||||||
| Date of disclosure of the study information |
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| Related information | |
| URL releasing protocol | https://www.spandidos-publications.com/10.3892/mco.2015.591 |
| Publication of results | Published |
| Result | |||||||
| URL related to results and publications | https://www.spandidos-publications.com/10.3892/mco.2015.591 | ||||||
| Number of participants that the trial has enrolled | 919 | ||||||
| Results | The iFOBT was an excellent examination as screening of colorectal tumours. The iFOBT might overlook small, flat or depressed tumours. Regardless of the result of iFOBT, CS for asymptomatic examinees (screening colonoscopy) might enable us to detect colorectal tumours in a curable state by the endoscopic treatment. |
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| Results date posted |
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| Results Delayed | |||||||
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| Date of the first journal publication of results | |||||||
| Baseline Characteristics | From December 2001 to August 2012, a total of 919 (276 iFOBT-positive and 643 iFOBT-negative) subclinical patients in the health screening program of our hospital underwent total colonoscopy within 2 years after iFOBT. |
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| Participant flow | We divided the patients into an iFOBT-positive group and iFOBT-negative group and compared the total colonoscopy findings between the two groups. |
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| Adverse events | None |
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| Outcome measures | The incidence and characteristics of colonic cancer lesions in asymptomatic, iFOBT-negative patients who underwent opportunistic screening. |
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| Progress | |||||||
| Recruitment status | Completed | ||||||
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| Date analysis concluded |
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| Last modified on |
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| Link to view the page | |
| URL(English) | https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014168 |
