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Radiogenomic Assessment in NSCLC: Correlation Between Multiparametric Imaging Biomarkers and Genetic Biomarkers

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Samsung Medical Center
Sponsor:
Information provided by (Responsible Party):
Ho Yun Lee, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01585545
First received: April 21, 2012
Last updated: November 9, 2014
Last verified: November 2014
  Purpose

The purpose of this study is to evaluate relationships between multiparametric imaging biomarkers and genetic analysis in NSCLC patients.


Condition
Lung Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Radiogenomic Assessment in NSCLC: Correlation Between Multiparametric Imaging Biomarkers and Genetic Biomarkers

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • functional and genetic profile of lung cancer [ Time Frame: two years ] [ Designated as safety issue: No ]

    following parameters will be calculated using these values:

    1. Metabolic parameters on FDG-PET
    2. Quantitative and qualitative parameters on CT
    3. Mutation analysis of lung cancer tissue


Secondary Outcome Measures:
  • relationship between genetic and multiparametric imaging profiling [ Time Frame: two years ] [ Designated as safety issue: No ]
    We will evaluate if certain relationship exists between changes in multiparametric imaging markers(metabolic parameters on FDG-PET, quantitative and qualitative parameters on CT) and genetic mutation pattern of NSCLC.


Biospecimen Retention:   Samples With DNA

lung cance tissue


Estimated Enrollment: 200
Study Start Date: October 2013
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
patients with NSCLC

Detailed Description:

To evaluate relationships between multiparametric imaging biomarkers(CT, PET/CT) and genetic analysis in NSCLC patients

  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

The patients with non-small cell lung cancer

Criteria

Inclusion Criteria:

  • Suspected lung cancer on chest CT or histologically proven NSCLC
  • Participant is being considered for the conventional/neoadjuvant/targeted chemotherapy or surgery
  • At least one measurable primary or other intrathoracic lesion >= 2cm, according to RECIST
  • Performance status of 0 to 2 on the ECOG scale
  • Age 20 years or older
  • Able to tolerable PET/CT and CT imaging required by protocol
  • Able to undergo percutaneous needle biopsy before and after chemotherapy
  • Able to give study-specific informed consent

Exclusion Criteria:

  • Poorly controlled diabetes
  • Contraindication for CT contrast agent
  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: NCT01585545

Contacts
Contact: Ho Yun Lee, Dr 82-2-3410-2502 ext 82-2-3410-2502 hoyunlee96@gmail.com

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Ho Yun Lee, Dr.    82-2-3410-2502 ext 82-2-3410-2502    hoyunlee96@gmail.com   
Principal Investigator: Ho Yun Lee, Dr.         
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Ho Yun Lee, Dr Samsung Medical Center
  More Information

No publications provided

Responsible Party: Ho Yun Lee, Assistant Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01585545     History of Changes
Other Study ID Numbers: 2012-03-068
Study First Received: April 21, 2012
Last Updated: November 9, 2014
Health Authority: South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:
CT
PET CT
mutational analysis

ClinicalTrials.gov processed this record on November 27, 2014