UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051316 |
|---|---|
| Receipt number | R000058535 |
| Scientific Title | Prospective observational study of colorectal cancer examining diagnosis opportunity and risk factors: CRC-DR study |
| Date of disclosure of the study information | 2023/06/12 |
| Last modified on | 2023/08/24 17:38:23 |
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Basic information
Public title
Prospective observational study of colorectal cancer examining diagnosis opportunity and risk factors, CRC-DR study
Acronym
CRC-DR study
Scientific Title
Prospective observational study of colorectal cancer examining diagnosis opportunity and risk factors: CRC-DR study
Scientific Title:Acronym
CRC-DR study
Region
| Japan |
Condition
Condition
colorectal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To prospectively enroll 1000 colorectal cancer patients from various facilities such as cancer centers, community hospitals, and clinics, and to investigate their history of colonoscopy and fecal occult blood test, and the trigger for detection.
Basic objectives2
Others
Basic objectives -Others
Factors associated with the development of colorectal cancer, such as alcohol consumption, smoking, exercise, family history of diet, marriage, education, and income, will also be investigated to examine their association.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Motivation and Symptoms of Colorectal Cancer Detection in Intramucosal vs. Invasive Cancer
Key secondary outcomes
To explore and evaluate the relationship between past colonoscopy and screening history and the occurrence of colorectal cancer at different levels of progression. We will also include life history, blood sampling data, and social background as risk factors for colorectal cancer to evaluate the relationship with the occurrence of colorectal cancer. In addition, we will conduct an exploratory comprehensive analysis using various items.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients newly diagnosed with colorectal cancer at each facility including referrals
Patients who have given written consent to participate in the research of their own free will
Patients who are 20 years of age or older at the time of consent
Key exclusion criteria
1. Patients with pathologically confirmed colorectal cancer in the past
2. Patients who the principal investigator determines to be unsuitable as subjects or whose consent cannot be obtained.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Naohisa |
| Middle name | |
| Last name | Yoshida |
Organization
Kyoto Prefectural University of Medicine
Division name
Molecular Gastroenterology and Hepatology
Zip code
602-8566
Address
Kajii-cho 465 Kamigyo-ku, Kyoto, Japan
TEL
0752515519
naohisa@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Naohisa |
| Middle name | |
| Last name | Yoshida |
Organization
Kyoto Prefectural Univedrsity of Medicine
Division name
Molecular Gastroenterology and Hepatology
Zip code
602-8566
Address
Kajii-cho 465 Kamigyo-ku, Kyoto, Japan
TEL
+81752515519
Homepage URL
naohisa@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Naohisa Yoshida
Funding Source
Organization
self-procurement
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Osaka International Cancer Center
Sano Hospital
Oda clinic
Ishikawa Gastroenterology Clinic
Japan General Hospital of West Japan Railway Company
Nishizin Hospital
Kyoto Saiseikai Hospital
Ayabe City Hospital
Kyoto First Red Cross Hospital
Otsu City Hospital
Aiseikai Yamashina Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB of Kyoto prefectural univeristy of medicine
Address
Kajii-cho 465, Kamigyo-ku, Kyoto, Japan
Tel
075-251-5337
rinri@koto.kpu-m.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
1. 大阪国際がんセンター(大阪府)
2. 医療法人 薫風会佐野病院(兵庫県)
3.尾田胃腸内科・内科(熊本県)
4. 医療法人いちょう会石川消化器内科(大阪府)
5. JR大阪鉄道病院(大阪府)
6. 西陣病院(京都府)
7. 済生会京都府病院(京都府)
8. 綾部市立病院(京都府)
9. 京都第一赤十字病院(京都府)
10. 市立大津市民病院(滋賀県)
11. 愛生会山科病院(京都府)
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 06 | Month | 12 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 25 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2023 | Year | 06 | Month | 10 | Day |
Last modified on
| 2023 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058535
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