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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2011 by Samsung Medical Center
Sponsor:
Collaborator:
Korean Foundation for Cancer Research
Information provided by (Responsible Party):
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01482585
First received: November 28, 2011
Last updated: November 29, 2011
Last verified: November 2011

November 28, 2011
November 29, 2011
October 2011
July 2016   (final data collection date for primary outcome measure)
Prediction of tumor aggressiveness [ Time Frame: five years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01482585 on ClinicalTrials.gov Archive Site
prognosis of early stage lung adenocarcinoma following operation [ Time Frame: five years ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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

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

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

lung tissue, serum

Non-Probability Sample

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

Lung Adenocarcinoma
Other: CT, PET, copy number alteration
Duel-energy CT, PET, copy number alteration
early stage lung adenocarcinoma
Intervention: Other: CT, PET, copy number alteration
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
December 2016
July 2016   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact: Young Mog Shim, Dr. youngmog.shim@samsung.com
Contact: Ho Yun Lee, Dr. hoyunlee96@gmail.com
Korea, Republic of
 
NCT01482585
SMC 2011-09-083
Yes
Samsung Medical Center
Samsung Medical Center
Korean Foundation for Cancer Research
Principal Investigator: Young Mog Shim, Dr. Samsung Medical Center
Samsung Medical Center
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP