UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018939 |
|---|---|
| Receipt number | 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 18:34:02 |
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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
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
tshimo@med.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Clinical Oncology and Chemotherapy, Nagoya University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021898
