UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017372 |
|---|---|
| Receipt number | R000020156 |
| Scientific Title | Explore for biomarkers that are useful for detection of gastrointestinal cancer and prediction of therapeutic response of gastrointestinal cancer by analyzing circulating tumor DNA (ctDNA) and circulating tumor cells (CTC) |
| Date of disclosure of the study information | 2015/05/01 |
| Last modified on | 2018/08/25 14:30:31 |
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Basic information
Public title
Explore for biomarkers that are useful for detection of gastrointestinal cancer and prediction of therapeutic response of gastrointestinal cancer by analyzing circulating tumor DNA (ctDNA) and circulating tumor cells (CTC)
Acronym
Diagnosis of gastrointestinal cancer using liquid biopsy
Scientific Title
Explore for biomarkers that are useful for detection of gastrointestinal cancer and prediction of therapeutic response of gastrointestinal cancer by analyzing circulating tumor DNA (ctDNA) and circulating tumor cells (CTC)
Scientific Title:Acronym
Diagnosis of gastrointestinal cancer using liquid biopsy
Region
| Japan |
Condition
Condition
Gastrointestinal cancer (esophageal cancer, stomach cancer, colorectal cancer)
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Identification of predictive biomarkers for therapeutic response
Basic objectives2
Others
Basic objectives -Others
Identification of markers of early cancer detection
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Utility of biomarkers of gastrointestinal cancer
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. patients with gastrointestinal cancer
2. patients with suspected gastrointestinal cancer
Key exclusion criteria
1. patients with inherited colorectal cancer syndromes
2. patients with inflammatory bowel disease
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eiji Kubota |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Gastroenterology and Metabolism
Zip code
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
TEL
052-851-5511
ekubota@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Eiji Kubota |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Gastroenterology and Metabolism
Zip code
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
TEL
052-851-5511
Homepage URL
ekubota@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Nagoya Daini Red Cross Hospital, Nagoya City East Medical Center, West Medical Center, Toyokawa City Hospital, Tajimi Hospital, Chukyo Hospital, Kasugai Municipal Hospital, Gamagoori Municipal Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 05 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 01 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 09 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
retrospective study
Management information
Registered date
| 2015 | Year | 05 | Month | 01 | Day |
Last modified on
| 2018 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020156
