Lung CancerNCT02050100
Biomarkers for Diagnosis of Lung Cancer
An observational study of Lung Cancer and Lung Neoplasm, run by SK Medical (Beijing) Co., Ltd. at 5 sites in China.
Trial summary
The study goal is to collect blood samples from individuals at risk for lung cancer in order to identify protein markers for diagnosis of lung cancer in the Chinese population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Lung Neoplasm
- How many people
- 300 participants
- Where
- 5 sitesChina
- Study dates
- Jan 2014to May 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of 300 patients will be recruited from hospital pulmonary clinics. The study participants will have pulmonary nodules suspicious for lung cancer and a bronchial biopsy diagnosis of NSCLC or probable benign. Approximately half of the patients will be cases and half controls.
Who may be able to join
- Adults ≥ 18 years of age
- Patients referred to pulmonologists, oncologists, or thoracic surgeons for diagnosis of suspicious pulmonary nodules as either lung cancer or benign and undergoing bronchoscopic biopsy
- Patients will be enrolled if the result of the bronchoscopic biopsy is a diagnosis of NSCLC or benign pulmonary nodule
- Cases: Patients with untreated non-small cell lung cancer, i.e. primary lung adenocarcinoma or squamous cell carcinoma of early
- Computed tomography or X-Ray is available and shows a suspicious pulmonary nodule
- A biopsy or surgical resection to clarify the nature of the lung nodule is available (NSCLC or benign, including histological diagnosis) in both groups
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- Controls: Patients must be available for a 6 month follow-up to confirm benign diagnosis
- A serum and plasma sample was collected prior to any treatment of the lung nodule beyond biopsy
- No other cancer diagnosis in the last 5 years excluding non-melanoma skin cancer
- Patients must be fully informed of the investigational nature of the procedure and sign an informed consent.
Who cannot join
- Prior treatment for lung cancer by chemotherapy or surgery (excluding biopsy)
- Patients with benign nodules who are not able or willing to have a 6-month follow-up visit to confirm benign diagnosis
- Diagnosis or treatment of other cancer in the last 5 years excluding non-melanoma skin cancer. In the judgment of the clinical investigator, patients who are likely to be non compliant or uncooperative during the study.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
The Second Affliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi
Zhongshan Hospital Fudan University
Shanghai
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, 225001
Henan province People's hospital
Zhengzhou
About this study
The study goal is to collect blood samples from individuals at risk for lung cancer in order to identify protein markers for diagnosis of lung cancer in the Chinese population.
- Conditions
- Lung Cancer, Lung Neoplasm
- Keywords
- primary lung adenocarcinoma Stages I, II, IIIA, IIIB, squamous cell carcinoma Stages I, II, IIIA, IIIB, benign non-calcified pulmonary nodules, early detection
- 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 |
|---|---|---|
| Lung Cancer | Early-late stage primary lung cancer | |
| Lung Neoplasm | Benign non-calcified pulmonary nodules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of blood biomarkers for detection of lung cancer
SK Telecom will utilize 15 single-plex quantitative Polymerase Chain Reaction (qPCR) assays to analyze an initial set of 300 clinical samples in China. SomaLogic will analyze these samples on the SOMAscan array (>1000 proteins) for additional lung cancer biomarker candidates.
Measured: 6 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionOct 2014
- Study completionMay 2015
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.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- SK Medical (Beijing) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chunxue Bai, M.D, Ph.D., Principal investigator, Zhongshan Hospital Fudan UniversitXiaoju Zhang, M.D., Principal investigator, Henan Provincial People's HospitalMuyun Zhu, M.D., Principal investigator, Northern Jiangsu People's HospitalKai Wang, MD, Principal investigator, The Second Affliated Hospital of Zhejiang University School of MedicineZuke Xiao, MD, Principal investigator, Jiangxi Provincial People's Hopital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02050100
- Sponsor's protocol ID
- SKTCTCH0001
- Status last verified
- May 2017
- First submitted
- 20 Jan 2014
- Last updated
- 12 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers for Diagnosis of Lung Cancer
- ClinicalTrials.gov ID
- NCT02050100
- Acronym / sponsor ID
- SKTCTCH0001
- Conditions
- Lung Cancer, Lung Neoplasm
- Keywords
- primary lung adenocarcinoma Stages I, II, IIIA, IIIB, squamous cell carcinoma Stages I, II, IIIA, IIIB, benign non-calcified pulmonary nodules, early detection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- SK Medical (Beijing) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 30 Jan 2014 (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 study goal is to collect blood samples from individuals at risk for lung cancer in order to identify protein markers for diagnosis of lung cancer in the Chinese population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lung Cancer | – | –Early-late stage primary lung cancer |
| Lung Neoplasm | – | –Benign non-calcified pulmonary nodules |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 300 patients will be recruited from hospital pulmonary clinics. The study participants will have pulmonary nodules suspicious for lung cancer and a bronchial biopsy diagnosis of NSCLC or probable benign. Approximately half of the patients will be cases and half controls.
Key inclusion criteria (10 listed)
- Adults ≥ 18 years of age
- Patients referred to pulmonologists, oncologists, or thoracic surgeons for diagnosis of suspicious pulmonary nodules as either lung cancer or benign and undergoing bronchoscopic biopsy
- Patients will be enrolled if the result of the bronchoscopic biopsy is a diagnosis of NSCLC or benign pulmonary nodule
- Cases: Patients with untreated non-small cell lung cancer, i.e. primary lung adenocarcinoma or squamous cell carcinoma of early
- Computed tomography or X-Ray is available and shows a suspicious pulmonary nodule
Key exclusion criteria (3 listed)
- Prior treatment for lung cancer by chemotherapy or surgery (excluding biopsy)
- Patients with benign nodules who are not able or willing to have a 6-month follow-up visit to confirm benign diagnosis
- Diagnosis or treatment of other cancer in the last 5 years excluding non-melanoma skin cancer. In the judgment of the clinical investigator, patients who are likely to be non compliant or uncooperative during the study.
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
Identification of blood biomarkers for detection of lung cancer
Time frame: 6 months after enrollment
SK Telecom will utilize 15 single-plex quantitative Polymerase Chain Reaction (qPCR) assays to analyze an initial set of 300 clinical samples in China. SomaLogic will analyze these samples on the SOMAscan array (>1000 proteins) for additional lung cancer biomarker candidates.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2017.
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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.
Chunxue Bai, M.D, Ph.D. principal investigator
Zhongshan Hospital Fudan Universit
Xiaoju Zhang, M.D. principal investigator
Henan Provincial People's Hospital
Muyun Zhu, M.D. principal investigator
Northern Jiangsu People's Hospital
5 sites 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 and Lung Neoplasm, run by SK Medical (Beijing) Co., Ltd. at 5 sites in China.
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 10 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: finished, as of the sponsor's last update on 12 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Identification of blood biomarkers for detection of lung cancer (time frame: 6 months after enrollment). 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 12 May 2017.