UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000046024
Receipt number R000052527
Scientific Title Evaluation of CD271 expression as a prognostic factor in non-small cell lung cancer patients
Date of disclosure of the study information 2021/11/10
Last modified on 2021/11/10 09:27:05

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Basic information

Public title

Evaluation of CD271 expression as a prognostic factor in non-small cell lung cancer patients

Acronym

Evaluation of CD271 expression as a prognostic factor in non-small cell lung cancer patients

Scientific Title

Evaluation of CD271 expression as a prognostic factor in non-small cell lung cancer patients

Scientific Title:Acronym

Evaluation of CD271 expression as a prognostic factor in non-small cell lung cancer patients

Region

Japan


Condition

Condition

Non-small cell lung cancer

Classification by specialty

Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study was to evaluate the relationship between the expression of CD271, a nerve growth factor receptor, and prognosis in patients with non-small cell lung cancer treated with surgical resection.

Basic objectives2

Others

Basic objectives -Others

We investigate the relationship between the expression of CD271 in non-small cell lung cancer cells and clinicopathological findings.

Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Recurrence-free survival (RFS)

Key secondary outcomes

Overall survival (OS)

Association between CD271 staining intensity and clinicopathological findings in non-small cell lung cancer

Relationship between the staining intensity of CD271 and the staining intensity of nerve growth factor receptor (NGF, BDGF, Neutrophin) and cancer stromal fibroblast marker molecules (alfa smooth muscle Actin, podoplanin)


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

Non-small cell lung cancer patients who were underwent surgical resection at the Department of Respiratory Surgery, Shiga University of Medical Science Hospital from January 1, 2008 to December 31, 2019

Key exclusion criteria

Patients who have refused to allow their samples and information to be used in this research

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Keiko Ueda

Organization

Shiga University of Medical Science

Division name

Department of Thoracic Surgery

Zip code

5202192

Address

Seta Tsukinowa-cho, Otsu, Shiga

TEL

0775482244

Email

hqsurg2@belle.shiga-med.ac.jp


Public contact

Name of contact person

1st name Keiko
Middle name Ueda
Last name Ueda

Organization

Shiga University of Medical Science

Division name

Department of Thoracic Surgery

Zip code

5202192

Address

Seta Tsukinowa-cho, Otsu, Shiga

TEL

0775482244

Homepage URL


Email

hqsurg2@belle.shiga-med.ac.jp


Sponsor or person

Institute

Shiga University of Medical Science

Institute

Department

Personal name



Funding Source

Organization

Shiga University of Medical Science

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

Shiga University of Medical Science

Address

Seta Tsukinowa-cho, Otsu, Shiga

Tel

0775482244

Email

hqsurg2@belle.shiga-med.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

2021 Year 11 Month 10 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

Open public recruiting

Date of protocol fixation

2021 Year 09 Month 15 Day

Date of IRB

2021 Year 09 Month 15 Day

Anticipated trial start date

2021 Year 09 Month 15 Day

Last follow-up date

2028 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

https://rinri.shiga-med.ac.jp/rinri/publish_document.aspx?ID=1539


Management information

Registered date

2021 Year 11 Month 10 Day

Last modified on

2021 Year 11 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052527