UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014095 |
|---|---|
| Receipt number | R000016408 |
| Scientific Title | Examination of the usefulness of the genetic test of Circulating tumor cells (CTCs) in patients with gastrointestinal cancer (Circle-1, Circle-2 Trial) |
| Date of disclosure of the study information | 2014/06/01 |
| Last modified on | 2021/06/02 13:45:41 |
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Basic information
Public title
Examination of the usefulness of the genetic test of Circulating tumor cells (CTCs) in patients with gastrointestinal cancer (Circle-1, Circle-2 Trial)
Acronym
Circle-1, Circle-2 Trial
Scientific Title
Examination of the usefulness of the genetic test of Circulating tumor cells (CTCs) in patients with gastrointestinal cancer (Circle-1, Circle-2 Trial)
Scientific Title:Acronym
Circle-1, Circle-2 Trial
Region
| Japan |
Condition
Condition
clinical stage IV gastrointestinal cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Circle 1:To assesse the concordance in genetic mutational status and protein expression level in primary tumors and their corresponding CTCs.
Circle 2:To assesse the correlation between emergence of genetical mutations in CTCs and change in therapeutic effect during molecular targeted therapy.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Circle-1: concordance rate in genetic mutational status in primary tumors and their corresponding CTCs.
Circle-2: correlation between emergence of genetical mutations in CTCs and change in therapeutic effect during molecular targeted therapy.
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
Circle 1:
1) Histologically proven gastrointestinal cancer (esophageal cancer, gastric cancer, colorectal cancer), and clinically judged adaptation of systemic chemotherapy
2) Aged 20 or more
3) Written informed consent
Circle 2:
1) Histologically proven gastrointestinal cancer (esophageal cancer, gastric cancer, colorectal cancer, GIST), and clinically judged adaptation of systemic chemotherapy
2) Aged 20 or more
3) Systemic chemotherapy using molecular targeted durg is planned
4) Written informed consent
Key exclusion criteria
1) Positive HIV antibody
2) Positive HBs antigen, HCV antibody
3) Positive TP antibody
4) Inadequate physical condition, as diagnosed by primary physician
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Ken Kato |
| Middle name | |
| Last name | Kazufumi Honda |
Organization
National Cancer Center Hospital, Research institute
Division name
Gastrointestinal Medical Oncology /Division of Chemotherapy and Clinical Research
Zip code
104-0045
Address
5-1-1, Tsukiji,Chuo-ku, Tokyo
TEL
03-3542-2511
kenkato@ncc.go.jp
Public contact
Name of contact person
| 1st name | Shoji |
| Middle name | |
| Last name | Hirokazu |
Organization
National Cancer Center Hospital
Division name
Gastrointestinal Medical Oncology
Zip code
104-0045
Address
5-1-1,Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
Homepage URL
hshouji@ncc.go.jp
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
Funding Source
Organization
National Cancer Center
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
NCCH IRB
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo
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
| 2014 | Year | 06 | 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
| 2013 | Year | 05 | Month | 13 | Day |
Date of IRB
| 2013 | Year | 05 | Month | 28 | Day |
Anticipated trial start date
| 2013 | Year | 05 | Month | 13 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2014 | Year | 05 | Month | 28 | Day |
Last modified on
| 2021 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016408
| 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 |
