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NCT01482585 Clinical Trial

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

Lung Adenocarcinoma Clinical Trial

Official title:
Prospective Study of Early-stage Lung Adenocarcinoma for Early Detection and Effective Treatment Strategy

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01482585
Other study ID # SMC 2011-09-083
Secondary ID
Status Recruiting
Phase N/A
First received November 28, 2011
Last updated November 29, 2011
Start date October 2011
Est. completion date December 2016

Study information
Verified date November 2011
Source Samsung Medical Center
Contact Young Mog Shim, Dr.
Email youngmog.shim@samsung.com
Is FDA regulated No
Health authority South Korea: Institutional Review Board
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date December 2016
Est. primary completion date July 2016
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility 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 ? neoadjuvant CCRTx

- C. Poor cardiopulmonary reserve

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Other:
• CT, PET, copy number alteration
Duel-energy CT, PET, copy number alteration

Locations
Country Name City State
Korea, Republic of Samsung Medical Center Seoul

Sponsors (2)
Lead Sponsor Collaborator
Samsung Medical Center Korean Foundation for Cancer Research

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Prediction of tumor aggressiveness five years Yes
Secondary prognosis of early stage lung adenocarcinoma following operation five years Yes
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