UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018656 |
|---|---|
| Receipt number | R000021602 |
| Scientific Title | Lung Cancer Genomic Screening Project for Individualized Medicine in Japan (LC-SCRUM-Japan): Prospective analyses of clinicopathological and molecular characteristics in small cell lung cancer harboring rare gene alterations including PI3K/AKT/mTOR pathway mutations (LC-SCRUM-Japan-SCLC) |
| Date of disclosure of the study information | 2015/08/12 |
| Last modified on | 2022/09/28 10:10:33 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Lung Cancer Genomic Screening Project for Individualized Medicine in Japan (LC-SCRUM-Japan): Prospective analyses of clinicopathological and molecular characteristics in small cell lung cancer harboring rare gene alterations including PI3K/AKT/mTOR pathway mutations (LC-SCRUM-Japan-SCLC)
Acronym
LC-SCRUM-Japan-SCLC
Scientific Title
Lung Cancer Genomic Screening Project for Individualized Medicine in Japan (LC-SCRUM-Japan): Prospective analyses of clinicopathological and molecular characteristics in small cell lung cancer harboring rare gene alterations including PI3K/AKT/mTOR pathway mutations (LC-SCRUM-Japan-SCLC)
Scientific Title:Acronym
LC-SCRUM-Japan-SCLC
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
To clarify small cell lung cancer harboring PI3K/AKT/mTOR pathway mutations and characterize its clinicopathological and molecular feature
Basic objectives2
Others
Basic objectives -Others
To evaluate the frequencies and characteristics of any cancer-related gene alterations in small cell lung cancer using OCP (Cancer Panel)
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To clarify the clinicopathological and molecular feature in small cell lung cancer harboring PI3K/AKT/mTOR pathway mutations
Key secondary outcomes
To evaluate the frequencies and characteristics of any cancer-related gene alterations in small cell lung cancer using OCP (Cancer Panel)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Histologically or cytologically confirmed small cell lung cancer
2.Chemotherapy is planned
3.ECOG performance status of 0 to 2
4.Adequate organ function (Correspond to the following values in laboratory tests performed within 14 days before registration)
a.Neutrophil count >= 1,500/mm3
b.Hemoglobin >= 8.0g/dL
c.Platelet count >= 75,000/mm3
d.AST,ALT: <= upper limits of normal (ULN)x2.5 (patients with liver metastasis; AST,ALT: <= ULNx5.0)
e.Total bilirubin: <= ULNx1.5
5.No serious comorbidities (for example: interstitial pneumonia, or uncontrolled diabetes mellitus, heart disease or infection)
6.Life expectancy of at least 3 months
7.Samples suitable for genomic analysis
8.Intention to register clinical trials
9.Written informed consent
Key exclusion criteria
None
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Goto |
| Middle name | |
| Last name | Goto |
Organization
National Cancer Center Hospital East
Division name
Department of Thoracic Oncology
Zip code
2778577
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan
TEL
04-7133-1111
kgoto@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Koichi |
| Middle name | |
| Last name | Goto |
Organization
National Cancer Center Hospital East
Division name
Department of Thoracic Oncology
Zip code
2778577
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan
TEL
04-7133-1111
Homepage URL
kgoto@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
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
National Cancer Center Institutional Review Board
Address
5-1-1 Tsukiji, Chuo-ku Tokyo
Tel
03-3542-2511
irst@ml.res.ncc.go.jp
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 | 08 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
1035
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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 05 | Month | 27 | Day |
Date of IRB
| 2015 | Year | 05 | Month | 27 | Day |
Anticipated trial start date
| 2015 | Year | 07 | Month | 03 | Day |
Last follow-up date
| 2025 | Year | 05 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a prospective observational study.
Management information
Registered date
| 2015 | Year | 08 | Month | 12 | Day |
Last modified on
| 2022 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021602
