Study of Early-stage Lung Adenocarcinoma for Early Detect... | NCT01482585

Studies
Study of Early-stage Lung Adenocarcinoma for Early Detection and Effective Treatment Strategy

NCT01482585

Sponsor

Samsung Medical Center

Status

Unknown status

Last Update Posted

Nov 30, 2011Estimated

Enrollment

200Estimated

Phase

Not provided

Conditions

Lung Adenocarcinoma

Interventions

CT, PET, copy number alteration

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

Nov 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2011

Primary Completion Date

Jul 2016Estimated

Completion Date

Dec 2016Estimated

First Submitted Date

Nov 28, 2011

First Submission Date that Met QC Criteria

Nov 29, 2011

First Posted Date

Nov 30, 2011Estimated

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

Nov 29, 2011

Last Update Posted Date

Nov 30, 2011Estimated

Name	Class
Korean Foundation for Cancer Research	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

to determine the values of imaging and genetic biomarkers for prediction of tumor aggressiveness and prognosis in patient with early stage lung adenocarcinoma to Identify unique copy number alteration in patient with early stage lung adenocarcinoma to evaluate the long-term change of ground-glass nodule combined with lung adenocarcinoma to suggest a guideline for planning an appropriate follow-up examination and management

Detailed Description

Not provided

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
early stage lung adenocarcinoma			Other: CT, PET, copy number alteration

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CT, PET, copy number alteration	Other	Duel-energy CT, PET, copy number alteration	early stage lung adenocarcinoma

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prediction of tumor aggressiveness		five years

Secondary Outcomes

Measure	Description	Time Frame
prognosis of early stage lung adenocarcinoma following operation		five years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

A. Clinically and radiologically suspected lung adenocarcinoma
B. Newly-diagnosed Stage I or II from the clinical work up including PET/CT
C. Performance status of 0 to 1 on the ECOG scale
D. Age 20 years or older
E. Able to tolerable DECT imaging required by protocol
F. Able to give study-specific informed consent

Exclusion Criteria:

A. Prior malignancy
B. planning of Definitive RTx 나 neoadjuvant CCRTx
C. Poor cardiopulmonary reserve

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients with stage I or II lung adenocarcinoma who plans curative operation

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Young Mog Shim, Dr.	Contact			youngmog.shim@samsung.com
Ho Yun Lee, Dr.	Contact			hoyunlee96@gmail.com

Overall Officials

Name	Affiliation	Role
Young Mog Shim, Dr.	Samsung Medical Center	Principal Investigator

Locations

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

Condition Browse Module

MeSH Terms

ID	Term
D000077192	Adenocarcinoma of Lung

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C062942	2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole
D056915	DNA Copy Number Variations

Ancestor Terms

ID	Term
D056914	Genomic Structural Variation
D011110	Polymorphism, Genetic
D014644	Genetic Variation
D055614	Genetic Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided