NCT01585545

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 26, 2012

Completed
1.4 years until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
12.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

May 5, 2022

Status Verified

May 1, 2022

Enrollment Period

12.2 years

First QC Date

April 21, 2012

Last Update Submit

May 3, 2022

Conditions

Lung Cancer

Keywords

CTPET CTMRIcancer genomicsRadiomicsRadiogenomics

Outcome Measures

Primary Outcomes (1)

  • Functional and genomic profiling of lung cancer

    Prognostic stratification will be evaluated using following parameters: 1. Quantitative and qualitative parameters from CT, PET, MRI 2. Genomic data of lung cancer samples

    five years

Secondary Outcomes (2)

  • Relationship between genomic and multiparametric imaging profiling

    five years

  • Precise prediction of pulmonary function such as ventilation and perfusion after the lung resection.

    five years

Study Arms (1)

patients with NSCLC

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The patients with non-small cell lung cancer

You may qualify if:

  • 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

You may not qualify if:

  • Poorly controlled diabetes
  • Contraindication for CT contrast agent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Biospecimen

Retention: SAMPLES WITH DNA

lung cance tissue

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Ho Yun Lee, Dr

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 21, 2012

First Posted

April 26, 2012

Study Start

October 1, 2013

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

May 5, 2022

Record last verified: 2022-05

Locations

KR(1)