UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019666 |
|---|---|
| Receipt number | R000022725 |
| Scientific Title | Genomic Analysis of Circulating Tumor Cells in Patients with Small Cell Lung Cancer |
| Date of disclosure of the study information | 2015/11/09 |
| Last modified on | 2019/11/14 18:14:08 |
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Basic information
Public title
Genomic Analysis of Circulating Tumor Cells in Patients
with Small Cell Lung Cancer
Acronym
Genomic Analysis of Circulating Tumor Cells in Patients
with Small Cell Lung Cancer
Scientific Title
Genomic Analysis of Circulating Tumor Cells in Patients
with Small Cell Lung Cancer
Scientific Title:Acronym
Genomic Analysis of Circulating Tumor Cells in Patients
with Small Cell Lung Cancer
Region
| Japan |
Condition
Condition
Small Cell Lung Cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Genomic Analysis of Circulating Tumor Cells in Patients
with Small Cell Lung Cancer
Basic objectives2
Others
Basic objectives -Others
Genomic Analysis of Circulating Tumor Cells in Patients
with Small Cell Lung Cancer
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
genomic analysis of circulating tumor cells in patients
with small cell lung cancer by collecting blood samples at pre-, and post- treatment.
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
patients newly diagnosed as having SCLC and starting chemotherapy or chemoradiotherapy
Key exclusion criteria
<20 years old
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yamaoka Toshimitsu |
Organization
Showa University
Division name
institute of molecular oncology
Zip code
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo
TEL
03-3784-8146
yamaoka.t@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yamaoka Toshimitsu |
Organization
Showa University
Division name
institute of molecular oncology
Zip code
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo
TEL
03-3784-8146
Homepage URL
yamaoka.t@med.showa-u.ac.jp
Sponsor or person
Institute
Yamaoka Toshimitsu
Institute
Department
Personal name
Funding Source
Organization
Showa University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Center for Antibody and Vaccine Therapy,
Research Hospital, The Institute of Medicine,
University of Tokyo
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
| 2015 | Year | 11 | Month | 09 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 11 | Month | 09 | Day |
Date of IRB
| 2015 | Year | 10 | Month | 28 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 09 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
patients with small cell lung cancer met the inclusion criteria and were prospectively enrolled between November 2015 and September 2018.
Management information
Registered date
| 2015 | Year | 11 | Month | 06 | Day |
Last modified on
| 2019 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022725
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
