UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022628 |
|---|---|
| Receipt number | 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 13:10:50 |
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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
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
hzenbuts@ncc.go.jp
Sponsor or person
Institute
Ministry of Health, Labour and Welfare
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014055
