Study of Early-stage Lung Adenocarcinoma for Early Detection and Effective Treatment Strategy
Prospective Study of Early-stage Lung Adenocarcinoma for Early Detection and Effective Treatment Strategy
1 other identifier
observational
200
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2011
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 28, 2011
CompletedFirst Posted
Study publicly available on registry
November 30, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedNovember 30, 2011
November 1, 2011
4.8 years
November 28, 2011
November 29, 2011
Conditions
Keywords
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
Interventions
Duel-energy CT, PET, copy number alteration
Eligibility Criteria
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
- Samsung Medical Centerlead
- Korean Foundation for Cancer Researchcollaborator
Study Sites (1)
Samsung Medical Center
Seoul, South Korea
Biospecimen
lung tissue, serum
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Young Mog Shim, Dr.
Samsung Medical Center
Central Study Contacts
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