UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011022 |
|---|---|
| Receipt number | R000012905 |
| Scientific Title | Prospective cohort follow up study of AminoIndex Cancer Screening |
| Date of disclosure of the study information | 2013/06/24 |
| Last modified on | 2023/02/07 16:29:51 |
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Basic information
Public title
Prospective cohort follow up study of AminoIndex Cancer Screening
Acronym
Prospective cohort follow up study of AminoIndex Cancer Screening
Scientific Title
Prospective cohort follow up study of AminoIndex Cancer Screening
Scientific Title:Acronym
Prospective cohort follow up study of AminoIndex Cancer Screening
Region
| Japan |
Condition
Condition
Cancer (gastric, colorectal, prostate, lung, breast, uterine, ovarian)
Classification by specialty
| Gastroenterology | Pneumology | Breast surgery |
| Obstetrics and Gynecology | Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Detection rate, accuracy(sensitivity, specificity), mortality and these outcomes with both AICS and other cancer screening tests
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Detection rate, accuracy(sensitivity, specificity), mortality and these outcomes with both AICS and other cancer screening tests
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
People receiving the AICS examination and signed the informed consent to participate in the study
Key exclusion criteria
Pregnancy
Target sample size
50000
Research contact person
Name of lead principal investigator
| 1st name | Shin |
| Middle name | |
| Last name | Maeda |
Organization
Yokohama City University
Division name
Gastroenterology
Zip code
2360004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004
TEL
045-787-2326
shinmaeda2-gi@umin.ac.jp
Public contact
Name of contact person
| 1st name | SHIN |
| Middle name | |
| Last name | MAEDA |
Organization
Yokohama City University
Division name
Gastroenterology
Zip code
2360004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama
TEL
0457872326
Homepage URL
shinmaeda2-gi@umin.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University
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
Yokohama city university review board
Address
3-9 Fukuura, Kanazawa-ku, yokohama
Tel
045-787-2800
onodera@yokohama-cu.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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 06 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2013 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2012 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2013 | Year | 06 | Month | 27 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
When the research partnership person who consulted AICS at the time of a medical examination or complete physical examination consultation is judged to be needed a detailed examination, the examination is conducted in Yokohama City University Hospital, and the result will be stored in a special area database. We will analyze about the accuracy of AICS using a special area database.
Management information
Registered date
| 2013 | Year | 06 | Month | 24 | Day |
Last modified on
| 2023 | Year | 02 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012905
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
