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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2016 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: October 12, 2016
Last verified: October 2016
  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: Radiomic 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 genomic profiling of lung cancer [ Time Frame: five years ] [ Designated as safety issue: No ]

    Prognostic stratification will be evaluated using following parameters:

    1. Quantitative and qualitative parameters from CT, PET, MRI
    2. Genomic data of lung cancer samples


Secondary Outcome Measures:
  • Relationship between genomic and multiparametric imaging profiling [ Time Frame: five years ] [ Designated as safety issue: No ]
    We will evaluate if certain relationship exists between changes in multiparametric imaging markers from CT, PET, MRI and genomic informations of NSCLC.

  • Precise prediction of pulmonary function such as ventilation and perfusion after the lung resection. [ Time Frame: five years ] [ Designated as safety issue: No ]
    following parameters exracted from whole lung will be evaluated: Quantitative parameters related to pulmonary function from CT, PET, MRI 2. Prediction of longitudinal changes of pulmonary function after the lung resection


Biospecimen Retention:   Samples With DNA
lung cance tissue

Estimated Enrollment: 500
Study Start Date: October 2013
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2018 (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, MRI) and genetic analysis in NSCLC patients
  Eligibility

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
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

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: October 12, 2016
Health Authority: South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:
CT
PET CT
MRI
cancer genomics
Radiomics
Radiogenomics

ClinicalTrials.gov processed this record on December 08, 2016