UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000059302
Receipt number R000067833
Scientific Title Prognosis Factors for Lung Cancer in Socially Vulnerable Groups (Welfare Recipients, Individuals Living Alone, and the Extreme Elderly)
Date of disclosure of the study information 2025/11/01
Last modified on 2025/10/06 11:58:48

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Basic information

Public title

Prognosis Factors for Lung Cancer in Socially Vulnerable Groups

Acronym

A Study on Lung Cancer Prognosis Factors in Socially Vulnerable Groups

Scientific Title

Prognosis Factors for Lung Cancer in Socially Vulnerable Groups (Welfare Recipients, Individuals Living Alone, and the Extreme Elderly)

Scientific Title:Acronym

Prognosis Factors for Lung Cancer in Socially Vulnerable Groups

Region

Japan


Condition

Condition

Lung cancer

Classification by specialty

Pneumology Hematology and clinical oncology Geriatrics

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

This study aims to retrospectively investigate background factors and treatment details among lung cancer patients with social vulnerabilities, such as those receiving public assistance, living alone, or being extremely elderly, and to explore measures for improving their prognosis.

Basic objectives2

Others

Basic objectives -Others

For lung cancer patients with social vulnerabilities such as receiving welfare benefits, living alone, or being extremely elderly, explore prognostic factors and establish a stable medical care system.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

To explore and identify issues concerning medical care and support systems tailored to the characteristics, condition, and progression of lung cancer patients receiving welfare benefits, living alone, or who are extremely elderly.

Key secondary outcomes

Investigation of the relationship between prognostic factors and psychological preferences in individual patient care and treatment selection.


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

18 years-old <=

Age-upper limit

100 years-old >=

Gender

Male and Female

Key inclusion criteria

The following criteria must be met by all eligible individuals:
Patients diagnosed with lung cancer based on imaging findings, tumor markers, histological findings, etc., who are receiving medical care at Tokyo Jikei University Katsushika Medical Center as inpatients or outpatients, and who are either receiving public assistance, living alone, or are super-elderly (aged 85 or older).
(1) Patients must have a medical record in any department at this hospital and a history of examination at this hospital.
(2) Patients aged 18 years or older and under 100 years of age.

Key exclusion criteria

Exclude individuals who meet any of the following exclusion criteria.
(1) Individuals who have declined to participate in the study
(2) Patients who have received a definitive diagnosis and treatment at another institution and have no record of intervention at this hospital.

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Yoshitaka
Middle name
Last name Seki

Organization

The Jikei University Katsushika Medical Center, Japan

Division name

Division of Respirology, Department of Internal Medicine

Zip code

125-8506

Address

6-41-2, Aoto, Katsushika-ku, Tokyo 125-8506, Japan

TEL

03-3603-2111

Email

yseki-jikd@umin.ac.jp


Public contact

Name of contact person

1st name Yoshitaka
Middle name
Last name Seki

Organization

The Jikei University Katsushika Medical Center, Japan

Division name

Division of Respirology, Department of Internal Medicine

Zip code

125-8506

Address

6-41-2, Aoto, Katsushika-ku, Tokyo 125-8506, Japan

TEL

03-3603-2111

Homepage URL


Email

yseki-jikd@umin.ac.jp


Sponsor or person

Institute

The Jikei University Katsushika Medical Center, Japan

Institute

Department

Personal name



Funding Source

Organization

The Jikei University Katsushika Medical Center, Japan

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

The Jikei University School of Medicine, Japan

Address

3-25-8, Nishi-Shimbashi, Minato-ku

Tel

03-3433-1111

Email

crb@jikei.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

2025 Year 11 Month 01 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

Suspended

Date of protocol fixation

2025 Year 07 Month 16 Day

Date of IRB

2025 Year 07 Month 16 Day

Anticipated trial start date

2025 Year 08 Month 20 Day

Last follow-up date

2025 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Explore and identify issues concerning medical care and support systems tailored to the characteristics, condition, and progression of lung cancer patients receiving welfare benefits, living alone, or who are extremely elderly.


Management information

Registered date

2025 Year 10 Month 06 Day

Last modified on

2025 Year 10 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067833