Lung AdenocarcinomaNCT01482585
Study of Early-stage Lung Adenocarcinoma for Early Detection and Effective Treatment Strategy
An observational study of Lung Adenocarcinoma, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Lung Adenocarcinoma
- What is being tested?
- CT, PET, copy number alteration
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2011to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with stage I or II lung adenocarcinoma who plans curative operation
Who may be able to join
- 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
Who cannot join
- A. Prior malignancy
- B. planning of Definitive RTx 나 neoadjuvant CCRTx
- C. Poor cardiopulmonary reserve
Trial locations and contacts
1 site in 1 country.
Young Mog Shim, Dr. contact
Ho Yun Lee, Dr. contact
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul
Lee, hj0503.lee@samsung.com
Young Mog Shim, Dr.
About this study
Official title: 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
- Conditions
- Lung Adenocarcinoma
- Being tested
- CT, PET, copy number alteration
- Keywords
- lung adenocarcinoma, prognosis, tumor aggressiveness, imaging biomarker, genetic biomarker
- Medical subject headings
- Adenocarcinoma of Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT, PET, copy number alterationOther
Duel-energy CT, PET, copy number alteration
| Study group | Role | What they receive |
|---|---|---|
| early stage lung adenocarcinoma | Not described Receives: Other: CT, PET, copy number alteration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction of tumor aggressiveness
Measured: five years
Secondary outcomes (1)
prognosis of early stage lung adenocarcinoma following operation
Measured: five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2011 (estimated)
- Study startOct 2011
- Primary completionJul 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Korean Foundation for Cancer Research
- Responsible party
- Sponsor
- Investigators
- Young Mog Shim, Dr., Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01482585
- Sponsor's protocol ID
- SMC 2011-09-083
- Status last verified
- Nov 2011
- First submitted
- 28 Nov 2011
- Last updated
- 30 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Early-stage Lung Adenocarcinoma for Early Detection and Effective Treatment Strategy
- ClinicalTrials.gov ID
- NCT01482585
- Acronym / sponsor ID
- SMC 2011-09-083
- Conditions
- Lung Adenocarcinoma
- Keywords
- lung adenocarcinoma, prognosis, tumor aggressiveness, imaging biomarker, genetic biomarker
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Korean Foundation for Cancer Research
- Study start
- Oct 2011
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 30 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| early stage lung adenocarcinoma | – | Other: CT, PET, copy number alteration |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with stage I or II lung adenocarcinoma who plans curative operation
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- A. Prior malignancy
- B. planning of Definitive RTx 나 neoadjuvant CCRTx
- C. Poor cardiopulmonary reserve
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT, PET, copy number alterationDuel-energy CT, PET, copy number alteration | Other | early stage lung adenocarcinoma |
Primary outcome
Prediction of tumor aggressiveness
Time frame: five years
1 secondary outcome
prognosis of early stage lung adenocarcinoma following operation
Time frame: five years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Young Mog Shim, Dr. contact
Ho Yun Lee, Dr. contact
Young Mog Shim, Dr. principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Adenocarcinoma, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Young Mog Shim, Dr. (youngmog.shim@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prediction of tumor aggressiveness (time frame: five years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2011.