UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015837 |
|---|---|
| Receipt number | R000018429 |
| Scientific Title | Value of usefulness of diffuse optical spectroscopic imaging for monitoring efficacy of aingle agent bevacizumab followed by Paclitaxel in breast cancer patients |
| Date of disclosure of the study information | 2014/12/03 |
| Last modified on | 2014/12/03 21:35:29 |
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Basic information
Public title
Value of usefulness of diffuse optical spectroscopic imaging for monitoring efficacy of aingle agent bevacizumab followed by Paclitaxel in breast cancer patients
Acronym
Diffuse optical spectroscopic imaging for monitoring bevacizumab and paclitaxel for breast cancer patinets
Scientific Title
Value of usefulness of diffuse optical spectroscopic imaging for monitoring efficacy of aingle agent bevacizumab followed by Paclitaxel in breast cancer patients
Scientific Title:Acronym
Diffuse optical spectroscopic imaging for monitoring bevacizumab and paclitaxel for breast cancer patinets
Region
| Japan |
Condition
Condition
Stage3/4 breast cancer patients
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Diffuse optical spectroscopic imaging (DOSI) has been described as a method to assess tumor vascularity and oxygenation by measuring tissue hemoglobin concentration. This technology is expected to develop a noninvasive hemodynamic biomarker for predicting of tumor response for an anti-anginogenic drug, bevacizumab. Because bevacizumab is frequently effective when combined with cytotoxic drugs, the aim of this study was to investigate the early response to single-agent bevacizumab.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The early hemoglobin response to single-agent bevacizumab.
Key secondary outcomes
Base
Study type
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
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Diffuse Optical Spectroscopy
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patinets who get informed and consent on paper.
Patient age 20 yo or more
Invasive breast cancer is confirmed by pathology
Patient with stage 3 or stage 4
HER2 negative breast cancer by IHC or FISH method
(6)ECOG Performance Status01 at baseline
Key exclusion criteria
(1) Patients who did not get informed consents on paper
(2) Patient whom doctor judges this treatment is suirtable for.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiaki Saeki |
Organization
Saitama Medical Univesity International Medical Center
Division name
Dept of breast oncology
Zip code
Address
1397-1,Yamane,Hidaka,Saitama
TEL
81-42-984-4670
tsaeki@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeto UEDA |
Organization
Saitama International Medical Center
Division name
Department of breast oncology
Zip code
Address
1397-1 Yamane, Hidaka, Saitama
TEL
81-42-984-4670
Homepage URL
syueda@saitama-med.ac.jp
Sponsor or person
Institute
International Medical Center, Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
JSPS KAKENHI Grant Number 25830105
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
埼玉医科大学国際医療センター
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 12 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2012 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 01 | 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
| 2014 | Year | 12 | Month | 03 | Day |
Last modified on
| 2014 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018429
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
