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
  Purpose

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


Condition Intervention
Lung Adenocarcinoma
Other: CT, PET, copy number alteration

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Prospective Study of Early-stage Lung Adenocarcinoma for Early Detection and Effective Treatment Strategy

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Prediction of tumor aggressiveness [ Time Frame: five years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • prognosis of early stage lung adenocarcinoma following operation [ Time Frame: five years ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA

lung tissue, serum


Estimated Enrollment: 200
Study Start Date: October 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
early stage lung adenocarcinoma Other: CT, PET, copy number alteration
Duel-energy CT, PET, copy number alteration

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01482585

Contacts
Contact: Young Mog Shim, Dr. youngmog.shim@samsung.com
Contact: Ho Yun Lee, Dr. hoyunlee96@gmail.com

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Lee       hj0503.lee@samsung.com   
Principal Investigator: Young Mog Shim, Dr.         
Sponsors and Collaborators
Samsung Medical Center
Korean Foundation for Cancer Research
Investigators
Principal Investigator: Young Mog Shim, Dr. Samsung Medical Center
  More Information

No publications provided

Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01482585     History of Changes
Other Study ID Numbers: SMC 2011-09-083
Study First Received: November 28, 2011
Last Updated: November 29, 2011
Health Authority: South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:
lung adenocarcinoma
prognosis
tumor aggressiveness
imaging biomarker
genetic biomarker

Additional relevant MeSH terms:
Adenocarcinoma
Lung Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 18, 2014