A Prospective Study for the Early Diagnosis of Lung Cance... | NCT06181929

Studies
A Prospective Study for the Early Diagnosis of Lung Cancer in Korean Females

NCT06181929

Sponsor

Sang-Won Um

Status

Recruiting

Last Update Posted

Mar 5, 2025Actual

Enrollment

200Estimated

Phase

Not Applicable

Conditions

Health Risk Behaviors

Interventions

Low dose CT

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2024Actual

Primary Completion Date

May 31, 2026Estimated

Completion Date

May 31, 2034Estimated

First Submitted Date

Nov 9, 2023

First Submission Date that Met QC Criteria

Dec 13, 2023

First Posted Date

Dec 26, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 2, 2025

Last Update Posted Date

Mar 5, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a single-arm prospective pilot study in a single institution. The target accrual is 200 participants of Korean, female sex, never smoker status, and family history of lung cancer. The study will aim to enroll 200 participants in two years.

Detailed Description

Interested individuals will contact a research coordinator who will help to assess for study eligibility. Individuals who are eligible and able to sign informed consent will then proceed to have a LDCT screening exam with a result reported by a radiologist approved to read lung cancer screening scans. Results of this screening test will be discussed with the subject and further recommendations will be given. Negative results will proceed to have repeat LDCT exams for two additional years. Positive results will be recommended to have further diagnostic work-up, and possible treatment. Those with positive findings may be recommended to repeat a LDCT at varied intervals (e.g. at 3 months, at 6 months, etc.) per Lung-RADS recommendations which can be conducted as a research LDCT or as standard-of-care.

In addition, blood draw collection for a plasma-based assay will be collected at baseline, first year and second year for all patients along with the repeated LDCT scans.

A medical history questionnaire containing questions regarding ethnicity, family history of lung cancer, environmental exposures including secondhand smoke exposure, and a residential district to estimate the exposure of PM2.5 or PM10 will be given to the patient at the initial visit after informed consent has been obtained (Appendix A). Questionnaire can be collected within 1 month from the baseline consent.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
intervation group	Experimental	LDCT screening exam	Diagnostic Test: Low dose CT

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Low dose CT	Diagnostic Test	A subject can voluntarily discontinue active screening with LDCTs after the baseline LDCT is completed but will remain in study follow-up with follow-up calls in 12-month intervals for up to 10 years since initial consent

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Lung cancer detection rate	detection rate	up to 2years

Secondary Outcomes

Measure	Description	Time Frame
incidence of lung cancer	Whether lung cancer is found in each screening test conducted for the first (baseline) and first and second years	up to 2years
distribution of lung cancer stages	number of lung cancer diagnosed, number of stage I, rate of surgery, rate of false positive

Other Outcomes

Measure	Description	Time Frame
identification of potential predictive biomarkers of malignancy	EGFR mutation	up to 2years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 45-74 years old
Korean female
Never smoker defined as a lifetime exposure of less than 100 cigarettes
Family history of lung cancer at first degree relatives (parents, siblings, or children)

Exclusion Criteria:

Prior history of lung cancer.
Diagnosis of any cancer within the past five years
Participation in a cancer prevention trial.
Present symptoms suggestive of current lung cancer, including: unexplained weight loss of over 5 kilograms within the last 12 months or unexplained hemoptysis.
Medical or psychiatric condition precluding informed medical consent.
History of LDCT screening, chest CT, PET or PET/CT scan within 10 years

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Korean female

Minimum Age

45 Years

Maximum Age

74 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Um Sang-Won, PhD	Contact	82-2-3410-1645		sangwonum72@gmail.com
Kyungmi Park	Contact	82-2-2008-0429		gyeong.mi@sbri.co.kr

Overall Officials

Name	Affiliation	Role
Um Sang-Won, PhD	Samsung Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Samsung Medical Center	Recruiting	Seoul	Seoul	06351	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000073599	Health Risk Behaviors

Ancestor Terms

ID	Term
D015438	Health Behavior
D001519	Behavior

Browse Leaves

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Browse Branches

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