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

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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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name