UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025835 |
|---|---|
| Receipt number | R000029569 |
| Scientific Title | Analysis of the responsible genome by the next generation sequencing (NGS) for drug sensitivity and prediction of prognosis in patients with newly diagnosed untreated multiple myeloma |
| Date of disclosure of the study information | 2017/02/01 |
| Last modified on | 2018/07/30 13:03:34 |
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Basic information
Public title
Analysis of the responsible genome by the next generation sequencing (NGS) for drug sensitivity and prediction of prognosis in patients with newly diagnosed untreated multiple myeloma
Acronym
Gene analysis using NGS of patients with newly diagnosed untreated multiple myeloma
Scientific Title
Analysis of the responsible genome by the next generation sequencing (NGS) for drug sensitivity and prediction of prognosis in patients with newly diagnosed untreated multiple myeloma
Scientific Title:Acronym
Gene analysis using NGS of patients with newly diagnosed untreated multiple myeloma
Region
| Japan |
Condition
Condition
Multiple Myeloma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To Identify genes that are associate with the dismal prognosis of multiple myeloma patients by analyzing targeted sequencing before treatment.
Basic objectives2
Others
Basic objectives -Others
To evaluate the correlation between tumor burden and prognosis by quantifying tumor volume in peripheral blood three months after the start of treatment with the use of NGS.
To evaluate the correlation between tumor burden and prognosis by quantifying tumor volume in peripheral blood six months after the start of treatment with the use of NGS.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Progression free survival (PFS) in each of the baseline genomic subgroup of at diagnosis.
Key secondary outcomes
Correlation of PFS and quantity of tumor element evaluated three months after the start of therapy
Correlation of PFS and quantity of tumor element evaluated six months after the start of therapy
Correlation of TNT and quantity of tumor element evaluated three months after the start of therapy
Correlation of TNT and quantity of tumor element evaluated six months after the start of therapy
Genetic mutations of myeloma cells associated with treatment
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
Previously untreated multiple myeloma patients diagnosed according to criteria of IMW conference report for 2014 and who are eligible for systemic treatment.
2.Provide who has written informed consent
Key exclusion criteria
1. 19 years or younger
2. Patients identified as ineligible by the directors and co-working of each institute.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshikazu Kamiya |
Organization
National Hospital Organization, Higashi Nagoya National Hospital
Division name
Division of Hematology and Medical Oncology
Zip code
Address
5-101 Umemorizaka, Meitou-Ku, Nagoya, Aichi
TEL
+81-52-801-1151
yskzkmy@e-nagoya.hosp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshikazu Kamiya |
Organization
National Hospital Organization, Higashi Nagoya National Hospital
Division name
Division of Hematology and Medical Oncology
Zip code
Address
5-101 Umemorizaka, Meitou-Ku, Nagoya, Aichi
TEL
+81-52-801-1151
Homepage URL
yskzkmy@e-nagoya.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization,
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization,
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
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
国立病院機構：渋川医療センター（群馬県）、千葉医療センター（千葉県）、東京医療センター（東京都）、まつもと医療センター（長野県）名古屋医療センター（愛知県）、東名古屋病院（愛知県）、あわら病院（福井県）、岡山医療センター（岡山県）、四国がんセンター（愛媛県）、九州医療センター（福岡県）、長崎医療センター（長崎県）鹿児島医療センター（鹿児島県）、
日本赤十字医療センター（東京都）京都鞍馬口医療センター（京都府）、新潟県立がんセンター新潟病院（新潟県）、豊橋市民病院（愛知県）、徳島大学（徳島県）、徳島県立中央病院（徳島県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 02 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 01 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 05 | Month | 21 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Data not published
Management information
Registered date
| 2017 | Year | 01 | Month | 25 | Day |
Last modified on
| 2018 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029569
