UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021934 |
|---|---|
| Receipt number | R000025281 |
| Scientific Title | The investigation and development of serum peptide biomarker for early detection of colorectal cancer. |
| Date of disclosure of the study information | 2016/04/18 |
| Last modified on | 2024/04/22 10:39:25 |
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Basic information
Public title
The investigation and development of serum peptide biomarker for early detection of colorectal cancer.
Acronym
The development of serum biomarker to detect early colorectal cancer.
Scientific Title
The investigation and development of serum peptide biomarker for early detection of colorectal cancer.
Scientific Title:Acronym
The development of serum biomarker to detect early colorectal cancer.
Region
| Japan |
Condition
Condition
colorectal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Detection of colorectal cancer at early stage contributes for good prognosis of patients and decrease mortality. In this study, we aimed to detect effective and new serum biomarker for diagnose colorectal cancer using serum samples of colorectal cancer patients and healthy control.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The detection rate of colorectal cancer using new serum biomarker.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. The patients who are diagnosed as colorectal cancer.
2. The patients who were performed for the therapy of colorectal cancer.
3. The patients who have colorectal polyps.
4. The patients who do not have colorectal cancer and other malignancy for healthy control.
Key exclusion criteria
1. The patients who have malignant tumor instead of colorectal cancer.
2. The patients who have performed the treatment for malignant tumor instead of colorectal cancer.
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Naito |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Molecular Gastroenterology and Hepatology
Zip code
602-8566
Address
465 Kajii-cho, Hirokoji, Kamigyo-ku, Kyoto, Japan
TEL
075-251-5519
ynaito@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Uchiyama |
Organization
Kyoto Prefectural University of Medicinea
Division name
Department of Molecular Gastroenterology and Hepatology
Zip code
602-8566
Address
465 Kajii-cho, Hirokoji, Kamigyo-ku, Kyoto, Japan Kajii-cho, Hirokoji, Kamigyo-ku, Kyoto, Japan
TEL
075-251-5519
Homepage URL
k-uchi@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prefectural University of Medicine
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
Kyoto Prefectural University of Medicine
Address
465 Kajii-cho, Hirokoji, Kamigyo-ku, Kyoto, Japan Kajii-cho, Hirokoji, Kamigyo-ku, Kyoto, Japan
Tel
075-723-5111
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2012 | Year | 04 | Month | 26 | Day |
Date of IRB
| 2012 | Year | 05 | Month | 15 | Day |
Anticipated trial start date
| 2012 | Year | 05 | Month | 15 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 31 | Day |
Other
Other related information
The blood from the patients who agreed this study was put on at room temperature for 2 hours. Then the serum was gathered by centrifuge and kept at -80.
Then the serum will be analyzed by BLOT-CHIP method to detect peptide, and CE-MS method to detect metabolome which is correlated to colorectal cancer stage.
Management information
Registered date
| 2016 | Year | 04 | Month | 16 | Day |
Last modified on
| 2024 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025281
| Research Plan | |
|---|---|
| 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 |
