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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000018939
Receipt No. R000021898
Scientific Title Analysis of drug distributions in tissue section using mass imaging technology in patients with breast cancer
Date of disclosure of the study information 2015/09/08
Last modified on 2016/09/07

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Basic information
Public title Analysis of drug distributions in tissue section using mass imaging technology in patients with breast cancer
Acronym Analysis of drug distributions in tissue section using mass imaging technology in patients with breast cancer
Scientific Title Analysis of drug distributions in tissue section using mass imaging technology in patients with breast cancer
Scientific Title:Acronym Analysis of drug distributions in tissue section using mass imaging technology in patients with breast cancer
Region
Japan

Condition
Condition breast cancer
Classification by specialty
Hematology and clinical oncology Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We consider the establishment and usefulness of the mass imaging technology approach to analyze the tissue distribution of the anti-neoplastic agents in patients with breast cancer.
Basic objectives2 PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes We confirm the correlation between the distribution and effectiveness of anti-cancer agents in breast cancer.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Operation.
Biopsy: We incise skin under local anesthesia, and perform a tumor biopsy by needle.
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 a. Histologically proven breast cancer patients
b. Patients to perform surgery or biopsy for diagnosis, treatment, or research purposes, in S-1, capecitabine, bevacizumab, trastuzumab, paclitaxel, nab-paclitaxel, or tamoxifen have been administered or scheduled to administer as the standard treatment,
c. Performance status (ECOG) 0, 1, 2
d. 20 years of age and older
e. Patients with tumor tissue which is thought to be located in safely collected sites
f. Written informed consent.

Key exclusion criteria a. Patients with active infection
b. Patients with other serious disease
c. Patients with coagulation abnormalities or patients who are not possible to rest anticoagulants
d. Patients with history of severe drug allergy
e. Pregnant or nursing females
f. Patients whose participation in the study is judged to be inappropriate by the attending doctor.

Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuichi Ando
Organization Nagoya University Hospital
Division name Clinical Oncology and Chemotherapy
Zip code
Address 65 Tsurumai-cho, Syowa-ku, Nagoya, Aichi
TEL 052-744-1903
Email yando@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomoya Shimokata
Organization Nagoya University Graduate School of Medicine
Division name Clinical Oncology and Chemotherapy
Zip code
Address 65 Tsurumai-cho, Syowa-ku, Nagoya, Aichi
TEL 052-744-1903
Homepage URL
Email tshimo@med.nagoya-u.ac.jp

Sponsor
Institute Department of Clinical Oncology and Chemotherapy, Nagoya University Hospital
Institute
Department

Funding Source
Organization Department of Clinical Oncology and Chemotherapy, Nagoya University Hospital
Organization
Division
Category of Funding Organization Self funding
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
2015 Year 09 Month 08 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 Terminated
Date of protocol fixation
2013 Year 10 Month 28 Day
Date of IRB
Anticipated trial start date
2013 Year 10 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 09 Month 08 Day
Last modified on
2016 Year 09 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021898

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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