UMIN-CTR Clinical Trial

Public title

Utility of Decision Support Tools and Identification of Influential Factors in Treatment Selection for Early-Stage Non-Small Cell Lung Cancer

Acronym

Utility of Decision Support Tools and Identification of Influential Factors in Treatment Selection for Early-Stage Non-Small Cell Lung Cancer

Scientific Title

Utility of Decision Support Tools and Identification of Influential Factors in Treatment Selection for Early-Stage Non-Small Cell Lung Cancer

Scientific Title:Acronym

Utility of Decision Support Tools and Identification of Influential Factors in Treatment Selection for Early-Stage Non-Small Cell Lung Cancer

Region

Japan

Condition

non-small cell lung cancer

Classification by specialty

Pneumology	Hematology and clinical oncology	Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To validate the utility of treatment decision-making guides for early-stage non-small cell lung cancer patients based on survey results. Concurrently, factors influencing treatment choices will be analyzed

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The primary outcome is the 'survey results regarding the decision-making guide for early-stage lung cancer patients'

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with a confirmed diagnosis of non-small cell lung cancer or those with a strong clinical suspicion.
Patients with clinical stage cT1N0M0 or cT2N0M0.
Patients eligible for both surgical treatment and SBRT for lung cancer.
Patients aged 18 or older.
Gender is not a consideration.

Key exclusion criteria

Patients who cannot appropriately utilize the treatment decision-making guide.
Patients who have already determined their treatment plan.
Other patients deemed ineligible by the primary physician.

Target sample size

30

Name of lead principal investigator

1st name	Takeshi
Middle name
Last name	Kaneko

Organization

Yokohama City University Graduate School of Medicine

Division name

Department of Pulmonology

Zip code

236-0004

Address

3-9 Fukuura, Kanazawa-ku, Yokohama, Japan

TEL

0457872800

Email

nkobayas@yokohama-cu.ac.jp

Name of contact person

1st name	Nobuaki
Middle name
Last name	Kobayashi

Organization

Yokohama City University Graduate School of Medicine

Division name

Department of Pulmonology

Zip code

236-0004

Address

3-9 Fukuura, Kanazawa-ku, Yokohama, Japan

TEL

045-787-2800

Homepage URL

Email

nkobayas@yokohama-cu.ac.jp

Institute

Yokohama City University

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

the Ethics Committee of Yokohama City University

Address

3-9 Fukuura Kanazawaku, Yokohama, Japan

Tel

0457872800

Email

nkobayas@yokohama-cu.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

10

Month

24

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Enrolling by invitation

Date of protocol fixation

2023

Year

09

Month

29

Day

Date of IRB

2023

Year

09

Month

29

Day

Anticipated trial start date

2023

Year

10

Month

24

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 related information

Samples
(1) Samples newly obtained for the study:
None
(2) Existing samples:
None

Information
(1) Information newly collected for the study (such as surveys conducted only for study participants):
Responses to questions in the "Decision Guide for Early Lung Cancer Patients"
Survey on the usefulness of the "Decision Guide for Early Lung Cancer Patients"
(2) Existing Information
Medical record information:

Background information: Age, gender, smoking history, drinking history, medical history, complications
PS at the time of registration
Clinical stage
Blood test results (at the time of registration):
Hematological examination (WBC count, WBC differential, Hb, platelet count)
Biochemical examination (total protein, serum albumin, total bilirubin, AST, ALT, LDH, CRP, gamma-GTP, BUN, serum creatinine, random blood sugar)
Tumor markers
Imaging examination: CT at the time of registration
Pulmonary function test (only if performed)
Pathological findings (only if results are available)
Treatment details

Registered date

2023

Year

10

Month

24

Day

Last modified on

2023

Year

10

Month

24

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060024