Lung CancerNCT01585545
Radiomic Assessment in NSCLC: Correlation Between Multiparametric Imaging Biomarkers and Genetic Biomarkers
An observational study of Lung Cancer, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate relationships between multiparametric imaging biomarkers and genetic analysis in NSCLC patients. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Lung Cancer
- How many people
- 500 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2013to Dec 2025
- 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: The patients with non-small cell lung cancer
Who may be able to join
- 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
Who cannot join
- Poorly controlled diabetes
- Contraindication for CT contrast agent
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate relationships between multiparametric imaging biomarkers and genetic analysis in NSCLC patients.
Read the detailed description
To evaluate relationships between multiparametric imaging biomarkers(CT, PET/CT, MRI) and genetic analysis in NSCLC patients
- Conditions
- Lung Cancer
- Keywords
- CT, PET CT, MRI, cancer genomics, Radiomics, Radiogenomics
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients with NSCLC | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional and genomic profiling of lung cancer
Prognostic stratification will be evaluated using following parameters:
- Quantitative and qualitative parameters from CT, PET, MRI
- Genomic data of lung cancer samples
Measured: five years
Secondary outcomes (2)
Relationship between genomic and multiparametric imaging profiling
We will evaluate if certain relationship exists between changes in multiparametric imaging markers from CT, PET, MRI and genomic informations of NSCLC.
Measured: five years
Precise prediction of pulmonary function such as ventilation and perfusion after the lung resection.
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
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 posted26 Apr 2012 (estimated)
- Study startOct 2013
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ho Yun Lee, Samsung Medical Center
- Investigators
- Ho Yun Lee, Dr, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01585545
- Sponsor's protocol ID
- 2012-03-068
- Status last verified
- May 2022
- First submitted
- 21 Apr 2012
- Last updated
- 5 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiomic Assessment in NSCLC: Correlation Between Multiparametric Imaging Biomarkers and Genetic Biomarkers
- ClinicalTrials.gov ID
- NCT01585545
- Acronym / sponsor ID
- 2012-03-068
- Conditions
- Lung Cancer
- Keywords
- CT, PET CT, MRI, cancer genomics, Radiomics, Radiogenomics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 26 Apr 2012 (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.
The purpose of this study is to evaluate relationships between multiparametric imaging biomarkers and genetic analysis in NSCLC patients.
Detailed description
To evaluate relationships between multiparametric imaging biomarkers(CT, PET/CT, MRI) and genetic analysis in NSCLC patients
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with NSCLC | – | – |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients with non-small cell lung cancer
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (2 listed)
- Poorly controlled diabetes
- Contraindication for CT contrast agent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Functional and genomic profiling of lung cancer
Time frame: five years
Prognostic stratification will be evaluated using following parameters: 1. Quantitative and qualitative parameters from CT, PET, MRI 2. Genomic data of lung cancer samples
2 secondary outcomes
Relationship between genomic and multiparametric imaging profiling
Time frame: five years
Precise prediction of pulmonary function such as ventilation and perfusion after the lung resection.
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 5 May 2022.
Related trials for Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
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.
Ho Yun Lee, 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 Cancer, 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 8 inclusion and 2 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 5 May 2022. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional and genomic profiling of lung cancer (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 5 May 2022.