NCT01482585

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 28, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 30, 2011

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

November 30, 2011

Status Verified

November 1, 2011

Enrollment Period

4.8 years

First QC Date

November 28, 2011

Last Update Submit

November 29, 2011

Conditions

Keywords

lung adenocarcinomaprognosistumor aggressivenessimaging biomarkergenetic biomarker

Outcome Measures

Primary Outcomes (1)

  • Prediction of tumor aggressiveness

    five years

Secondary Outcomes (1)

  • prognosis of early stage lung adenocarcinoma following operation

    five years

Study Arms (1)

early stage lung adenocarcinoma

Other: CT, PET, copy number alteration

Interventions

Duel-energy CT, PET, copy number alteration

early stage lung adenocarcinoma

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

lung tissue, serum

MeSH Terms

Conditions

Adenocarcinoma of Lung

Interventions

2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazoleDNA Copy Number Variations

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by Site

Intervention Hierarchy (Ancestors)

Genomic Structural VariationPolymorphism, GeneticGenetic VariationGenetic Phenomena

Study Officials

  • Young Mog Shim, Dr.

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Young Mog Shim, Dr.

CONTACT

Ho Yun Lee, Dr.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2011

First Posted

November 30, 2011

Study Start

October 1, 2011

Primary Completion

July 1, 2016

Study Completion

December 1, 2016

Last Updated

November 30, 2011

Record last verified: 2011-11

Locations