UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040851
Receipt number R000046624
Scientific Title A retrospective evaluation of stem cell markers and tumor mutation burden as a potential risk factor for surgical recurrence (WJOG12219LTR)
Date of disclosure of the study information 2020/06/22
Last modified on 2022/12/26 09:18:32

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Basic information

Public title

A retrospective evaluation of stem cell markers and tumor mutation burden as a potential risk factor for surgical recurrence (WJOG12219LTR)

Acronym

Cancer stem cell markers and tumor mutation burden in resectable non-small cell lung cancer (WJOG12219LTR)

Scientific Title

A retrospective evaluation of stem cell markers and tumor mutation burden as a potential risk factor for surgical recurrence (WJOG12219LTR)

Scientific Title:Acronym

Cancer stem cell markers and tumor mutation burden in resectable non-small cell lung cancer (WJOG12219LTR)

Region

Japan


Condition

Condition

Resectable stage II-IIIA non-small cell lung cancer

Classification by specialty

Medicine in general Pneumology Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate cancer stem cell markers, tumor mutation burden in stage II-IIIA non-small cell lung cancer registered in WJOG4107

Basic objectives2

Others

Basic objectives -Others

Evaluation of biomarkers

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The association of cancer stem cell markers (CD44, CD133), tumor mutation burden, PD-L1 expression on tumor cells and CD8 expression on tumor infiltrating lymphocytes, and relapse-free survival

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

75 years-old >

Gender

Male and Female

Key inclusion criteria

Patients enrolled in WJOG4107 study whose DNA and tissue samples are available.

Key exclusion criteria

None

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Masayuki
Middle name
Last name Takeda

Organization

Kindai University, Faculty of Medicine

Division name

Department of Medical Oncology

Zip code

589-8511

Address

377-2, Ohno-higashi, Osakasayama City, Osaka

TEL

072-366-0221

Email

takeda_m@med.kindai.ac.jp


Public contact

Name of contact person

1st name Shinichiro
Middle name
Last name Nakamura

Organization

West Japan Oncology Group

Division name

WJOG datacenter

Zip code

556-0016

Address

Namba Plaza Bldg. 304-1-5-7, Motomachi Naniwa-ku, Osaka, JAPAN

TEL

06-6633-7400

Homepage URL


Email

datacenter@wjog.jp


Sponsor or person

Institute

West Japan Oncology Group

Institute

Department

Personal name



Funding Source

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kindai University, Faculty of Medicine

Address

377-2, Ohno-higashi, Osakasayama City, Osaka

Tel

072-366-0221

Email

takeda_m@med.kindai.ac.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

2020 Year 06 Month 22 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

135

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

2020 Year 06 Month 20 Day

Date of IRB

2020 Year 07 Month 21 Day

Anticipated trial start date

2020 Year 08 Month 03 Day

Last follow-up date

2023 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

A retrospective study to evaluate the association of cancer stem cell markers and tumor mutation burden, and clinical background/characteristics and prognosis in resectable stage II-IIIA non-small cell lung cancer


Management information

Registered date

2020 Year 06 Month 22 Day

Last modified on

2022 Year 12 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046624


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name