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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033144
Receipt No. R000037742
Scientific Title Feasibility study of clinical sequence in adult malignant lymphoma.
Date of disclosure of the study information 2018/06/25
Last modified on 2018/06/25

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Basic information
Public title Feasibility study of clinical sequence in adult malignant lymphoma.
Acronym Study of clinical sequence in malignant lymphoma.
Scientific Title Feasibility study of clinical sequence in adult malignant lymphoma.
Scientific Title:Acronym Study of clinical sequence in malignant lymphoma.
Region
Japan

Condition
Condition Malignant lymphoma
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To investigate the feasibility of clinical sequence in the diagnosis and treatment of malignant lymphoma.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Ratio of potentially actionable findings(PAF),
used as a feedback to the attending physician
Key secondary outcomes

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 All items listed below are required.
1) Diagnosed as diffuse large B-cell lymphoma (DLBCL) in WHO classification (2016).
2) Twenty years old or higher age.
3) Tumor or non-tumor tissues are available for genome analyses.
Tumor tissue sample: a) and b)
a) biopsy sample at diagnosis (frozen tissues, cell suspension, or genome DNA)
b) Formalin fixed parafin embedded (FFPE) tissue section samples for histological analyses.
Non-tumor tissue samples: a) or b)
a) peripheral blood sample at diagnosis
b) peripheral blood sample at entry
4) Patients who filled out the informed consent forms.
Key exclusion criteria 1) Patients enrolled in another critical trials for treatment.
2) Patients who can not obtain enough amount of DNA samples for genome analyses.
3) A subject considered as an inappropriate participant for the current study.
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akihiro Tomita
Organization Fujita Health University School of Medicine
Division name Department of Hematology
Zip code
Address 1-98 Dengakugakubo, Kutsukake-cho, Toyoake 470-1192, Aichi, Japan.
TEL +81-562-93-9243
Email atomita@fujita-hu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akinao Okamoto
Organization Fujita Health University School of Medicine
Division name Department of Hematology
Zip code
Address 1-98 Dengakugakubo, Kutsukake-cho, Toyoake 470-1192, Aichi, Japan.
TEL +81-562-93-9243
Homepage URL
Email aokamoto@fujita-hu.ac.jp

Sponsor
Institute Agency for Medical Research and Development; Program for an Integrated Database of Clinical and Genomic Information; Horibe research team.
Institute
Department

Funding Source
Organization Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
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
2018 Year 06 Month 25 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 Preinitiation
Date of protocol fixation
2018 Year 04 Month 28 Day
Date of IRB
Anticipated trial start date
2018 Year 06 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective observational study.
Using the next generation sequencing, we evaluate the ratio of the adult malignant lymphoma cases with PAF (Potentially actionable findings), and evaluate the feasibility of clinical sequence in the diagnosis and treatment of malignant lymphoma.

Management information
Registered date
2018 Year 06 Month 25 Day
Last modified on
2018 Year 06 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037742

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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