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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000014095
Receipt No. 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 2020/06/01

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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
Middle name
Last name Ken Kato/ Kazufumi Honda
Organization National Cancer Center Hospital, Research institute
Division name Gastrointestinal Medical Oncology /Division of Chemotherapy and Clinical Research
Zip code
Address 5-1-1, Tsukiji,Chuo-ku, Tokyo
TEL 03-3542-2511
Email kenkato@ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hirokazu Shoji
Organization National Cancer Center Hospital
Division name Gastrointestinal Medical Oncology
Zip code
Address 5-1-1,Tsukiji, Chuo-ku, Tokyo
TEL 03-3542-2511
Homepage URL
Email hshouji@ncc.go.jp

Sponsor
Institute National Cancer Center
Institute
Department

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
Address
Tel
Email

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
2020 Year 06 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016408

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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