UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000050879
Receipt number R000057982
Scientific Title Analysis of the roles of integrin family members in lung adenocarcinoma
Date of disclosure of the study information 2023/04/20
Last modified on 2023/04/18 16:38:51

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Basic information

Public title

Analysis of the roles of integrin family members in lung adenocarcinoma

Acronym

Analysis of the roles of integrin family members in lung adenocarcinoma

Scientific Title

Analysis of the roles of integrin family members in lung adenocarcinoma

Scientific Title:Acronym

Analysis of the roles of integrin family members in lung adenocarcinoma

Region

Japan


Condition

Condition

Lung adenocarcinoma

Classification by specialty

Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to identify poor prognostic factors and to generate a prognostic prediction score through analysis of expressions and functions of integrin family members in cancer-associated fibroblasts in patients with lung adenocarcinoma

Basic objectives2

Others

Basic objectives -Others

Identify poor prognostic factors

Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

To evaluate the expression of integrin family members in cancer-associated fibroblasts in lung adenocarcinoma tissues by immunohistochemistry, and to compare it with clinicopathological factors.

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

90 years-old >

Gender

Male and Female

Key inclusion criteria

The patients who underwent surgical resection of lung adenocarcinoma

Key exclusion criteria

Recurrent tumors or metastatic cancers are ruled out.

Target sample size

140


Research contact person

Name of lead principal investigator

1st name Takashi
Middle name
Last name Suzuki

Organization

Tohoku University

Division name

Department of Anatomic Pathology, Graduate School of Medicine

Zip code

9808575

Address

2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan.

TEL

0227178050

Email

t-suzuki@patholo2.med.tohoku.ac.jp


Public contact

Name of contact person

1st name Chihiro
Middle name
Last name Inoue

Organization

Tohoku University

Division name

Department of Anatomic Pathology, Graduate School of Medicine

Zip code

980

Address

2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan.

TEL

0227178050

Homepage URL


Email

chihiro_inoue@med.tohoku.ac.jp


Sponsor or person

Institute

Tohoku University

Institute

Department

Personal name

Chihiro Inoue


Funding Source

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethics Committee Tohoku University Graduate School of Medicine

Address

2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan

Tel

022-717-8007

Email

med-kenkyo@grp.tohoku.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

2023 Year 04 Month 20 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

Enrolling by invitation

Date of protocol fixation

2023 Year 02 Month 01 Day

Date of IRB

2023 Year 03 Month 01 Day

Anticipated trial start date

2023 Year 04 Month 01 Day

Last follow-up date

2025 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

This study is an observational study using specimens resected for treatment.


Management information

Registered date

2023 Year 04 Month 18 Day

Last modified on

2023 Year 04 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057982


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name