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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024619
Receipt No. 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

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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
Email 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
Email matsumotosg7@gmail.com

Sponsor
Institute Nihon University School of Medicine, Itabashi Hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028270

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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