UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024619 |
|---|---|
| Receipt number | R000028270 |
| Scientific Title | Early response evaluation of chemotherapy in malignant lymphoma by contrast-enhanced ultrasonography |
| Date of disclosure of the study information | 2016/10/31 |
| Last modified on | 2016/10/29 08:50:28 |
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Basic information
Public title
Early response evaluation of chemotherapy in malignant lymphoma by contrast-enhanced ultrasonography
Acronym
Contrast-enhanced ultrasonography for malignant lymphoma
Scientific Title
Early response evaluation of chemotherapy in malignant lymphoma by contrast-enhanced ultrasonography
Scientific Title:Acronym
Contrast-enhanced ultrasonography for malignant lymphoma
Region
| Japan |
Condition
Condition
malignant lymphoma
Classification by specialty
| Hematology and clinical oncology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate predictive value of contrast-enhanced ultrasonography and elastography for early response of chemotherapy in malignant lymphoma, comparison with response rate
Basic objectives2
Others
Basic objectives -Others
Comparison between contrast-enhanced ultrasonographic findings and contrast-enhanced CT findings.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Comparison between some parameters (Time to peak, Area under the curve, etc.) obtained by contrast-enhanced ultrasonography 3, 7, 14 days after start of chemotherapy and response rate.
Key secondary outcomes
Comparison between tissue stiffness obtained by elastography 3, 7, 14 days after start of chemotherapy and response rate.
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
1) patients with histological confirmed malignant lymphoma
2) target lesion can be depicted by ultrasonography
3) hospiterized patient
4) patients who consented to participate in this study
Key exclusion criteria
1) history of allergy to Sonazoid
2) history of allergy to egg
3) not eligible for this study judged by doctors
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoki Matsumoto |
Organization
Nihon University School of Medicine, Itabashi Hospital
Division name
Division of Gastroenterology and Hepatology, Department of Medicine
Zip code
Address
30-1, Oyaguchi kamimachi, Itabashi-ku, Tokyo 173-8610, Japan.
TEL
03-3972-8111
matsumotosg7@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoki Matsumoto |
Organization
Nihon University School of Medicine, Itabashi Hospital
Division name
Division of Gastroenterology and Hepatology, Department of Medicine
Zip code
Address
30-1, Oyaguchi kamimachi, Itabashi-ku, Tokyo 173-8610, Japan.
TEL
03-3972-8111
Homepage URL
matsumotosg7@gmail.com
Sponsor or person
Institute
Nihon University School of Medicine, Itabashi Hospital
Institute
Department
Personal name
Funding Source
Organization
Nihon University School of Medicine, Itabashi Hospital
Organization
Division
Category of Funding Organization
Other
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 | 10 | Month | 31 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 12 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | Month | 05 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Compare the findings of contrast-enhanced ultrasonography, before and 3, 7, 14 days after start of the chemotherapy for malignant lymphoma
Management information
Registered date
| 2016 | Year | 10 | Month | 29 | Day |
Last modified on
| 2016 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028270
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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