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

November 29, 2011 updated by: Samsung Medical Center

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
early stage lung adenocarcinoma
Other: CT, PET, copy number alteration
Duel-energy CT, PET, copy number alteration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prediction of tumor aggressiveness
Time Frame: five years
five years

Secondary Outcome Measures

Outcome Measure
Time Frame
prognosis of early stage lung adenocarcinoma following operation
Time Frame: five years
five years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Collaborators

Korean Foundation for Cancer Research

Investigators

  • Principal Investigator: Young Mog Shim, Dr., Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Anticipated)

July 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

November 28, 2011

First Submitted That Met QC Criteria

November 29, 2011

First Posted (Estimate)

November 30, 2011

Study Record Updates

Last Update Posted (Estimate)

November 30, 2011

Last Update Submitted That Met QC Criteria

November 29, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMC 2011-09-083

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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