UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042003 |
|---|---|
| Receipt number | R000043671 |
| Scientific Title | Observational Study of circulating-tumor DNA in Patients with Gastrointestinal Cancer |
| Date of disclosure of the study information | 2020/10/05 |
| Last modified on | 2021/10/06 11:08:06 |
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Basic information
Public title
Observational Study of circulating-tumor DNA in Patients with Gastrointestinal Cancer
Acronym
Observational Study of circulating-tumor DNA in Patients with Gastrointestinal Cancer
Scientific Title
Observational Study of circulating-tumor DNA in Patients with Gastrointestinal Cancer
Scientific Title:Acronym
Observational Study of circulating-tumor DNA in Patients with Gastrointestinal Cancer
Region
| Japan |
Condition
Condition
Esophageal cancer, Esophago-gastric junctional cancer, Gastric cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To clarify clinical utility of detecting MRD and monitoring using ctDNA analysis in patients with gastrointestinal cancer who plan to undergo curative treatment.
Basic objectives2
Others
Basic objectives -Others
To evaluate clinical performance of ctDNA analysis.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between RFS and ctDNA in patients with gastrointestinal cancer who underwent curative treatment (R0/R1 resection).
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Esophageal cancer, esophago-gastric junction cancer, gastric cancer by clinical or histological diagnosis
2) Patients who plan to curative treatment
3) Age >= 20 year old.
4) Written informed consent obtained.
Key exclusion criteria
1) Patients with double cancer (excluding early or superficial cancers which can be curatively resected by endoscopic treatment)
2) Any other patients who are regarded as inadequate for study enrollment by principal investigators.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Kojima |
Organization
National Cancer Center Hospital East
Division name
Department of Gastroenterology and Gastrointestinal Oncology
Zip code
277-8577
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577 Japan
TEL
04-7133-1111
takojima@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Kotani |
Organization
National Cancer Center Hospital East
Division name
Department of Gastroenterology and Gastrointestinal Oncology
Zip code
277-8577
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577 Japan
TEL
04-7133-1111
Homepage URL
dkotani@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
National Cancer Center Hospital East
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
NCC IRB office
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan
Tel
03-3542-2511
NCC_IRBoffice@ml.res.ncc.go.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
| 2020 | Year | 10 | Month | 05 | 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
| 2019 | Year | 10 | Month | 11 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 16 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: Observational study
Management information
Registered date
| 2020 | Year | 10 | Month | 04 | Day |
Last modified on
| 2021 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043671
| 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 |
