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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022628
Receipt No. R000014055
Scientific Title Prospective Clinical Study to Clarify the Relationship between CYP2D6 Genotype and the Therapeutic Effects of Preoperative Tamoxifen Therapy
Date of disclosure of the study information 2016/06/06
Last modified on 2018/06/11

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Basic information
Public title Prospective Clinical Study to Clarify the Relationship between CYP2D6 Genotype and the Therapeutic Effects of Preoperative Tamoxifen Therapy
Acronym C-GENT study
Scientific Title Prospective Clinical Study to Clarify the Relationship between CYP2D6 Genotype and the Therapeutic Effects of Preoperative Tamoxifen Therapy
Scientific Title:Acronym C-GENT study
Region
Japan Asia(except Japan)

Condition
Condition Breast Cancer
Classification by specialty
Breast surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 Investigation of association between CYP2D6 variants and change in Ki67 labeling index after treatment with tamoxifen
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change in Ki-67 labeling index after tamoxifen treatment
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 Patients who meet all the following criteria are eligible:
1)Patients who are histopathologically diagnosed with invasive breast cancer by biopsy, etc.;
2)Estrogen receptor-positive (the percentage of positive cells is 10% or more by immunohistological methods);
3)Stage I to IIIA;
4)Her2 negative (2+ and FISH-negative or 1+ or less);
5)Age when the treatment is initiated: 21 years or older;
6)Negative pregnancy test for patients who are in the reproductive age group;
7)Tissue specimens for measurement of Ki67 are available before initiating treatment;
8)Patients who are fully informed of and understand preoperative tamoxifen therapy properly before participation in this study, and subsequently submit their voluntary written informed consent to receive the therapy.
Key exclusion criteria Patients who meet any of the following criteria are excluded from this clinical study:
1)Non-invasive cancer;
2)Renal dysfunction (dialysis patients with serum creatinine 2.5 mg/dL);
3)Patients with severe hepatic dysfunction (AST, ALT, and total bilirubin levels are all 1.5 or more times the institutional reference range);
4)Patients who are considered to have difficulty in complying with the procedures, observations, etc. specified in the protocol;
5)Patients who are considered to be inappropriate as a subject of this study by the investigator.
Target sample size 450

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hitoshi Zembutsu
Organization National Cancer Center Research Institute
Division name Division of Genetics
Zip code
Address Tsukiji 5-1-1, Chuou-ku, TOKYO
TEL 03-3542-2511
Email hzenbuts@ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hitoshi Zembutsu
Organization National Cancer Center Research Institute
Division name Division of Genetics
Zip code
Address Tsukiji 5-1-1, Chuou-ku, TOKYO
TEL 03-3542-2511
Homepage URL
Email hzenbuts@ncc.go.jp

Sponsor
Institute Ministry of Health, Labour and Welfare
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
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
2016 Year 06 Month 06 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 Completed
Date of protocol fixation
2012 Year 05 Month 06 Day
Date of IRB
Anticipated trial start date
2012 Year 07 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Change in Ki-67 labeling index after tamoxifen therapy

Management information
Registered date
2016 Year 06 Month 06 Day
Last modified on
2018 Year 06 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014055

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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