Lung CancerECLCNCT04216511
Early Cancer Detection Test - Lung Cancer China
An observational study of Lung Cancer, run by Bai Chunxue at 3 sites in China.
Trial summary
Lung cancer is the most common cancer in China from both incidence and mortality rate point of view, with significantly lower 5-year survival rate than average. Early detection is the recognized solution. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Tumor autoantibody detection
- How many people
- 1,000 participants
- Where
- 3 sitesChina
- Study dates
- 22 Aug 2019to Jun 2021
- 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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals diagnosed with lung cancer, benign pulmonary nodule or identified as at-risk healthy volunteer in participating hospitals of this study, from the recruitment starting date, till the end of the study.
Who may be able to join
- Male or female aged 18 or above.
- Individuals complying with either of the following
- diagnosed as lung cancer (histopathologically confirmed);
- diagnosed as benign pulmonary nodule (confirmed by pathology or by follow-up based on 2018 Chinese Consensus on Pulmonary Nodule Diagnosis and Treatment);
- without pulmonary nodule but with lung cancer risk factor, age \& gender matched recruited lung cancer patients.
- Participant is willing and able to provide necessary information required in CRF.
- Participant is willing and able to give informed consent for participation in the study.
Who cannot join
- History of any cancer;
- Lung cancer patient who received or is receiving any treatment, including but not limited to surgery, radiotherapy, chemotherapy, targeted therapy and immunotherapy.
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, 200000
Chunxue Bai, MD, 18621170011, bai.chunxue@zs-hospital.sh.cn
Jian Zhou, MD, 18221223320, zhou.jian@fudan.edu.cn
- Recruiting
Shanghai Chest Hospital
Shanghai
Jiayuan Sun, MD, 86-21-22200000 ext. 1511, jysun1976@163.com
- Not yet recruiting
Henan Province People's Hospital
Zhengzhou
Xiaoju Zhang, zhangxiaoju1010@hotmail.com
About this study
Official title: Clinic Validation of Autoantibody Panel for Lung Cancer Diagnosis in Chinese Population
Lung cancer is the most common cancer in China from both incidence and mortality rate point of view, with significantly lower 5-year survival rate than average. Early detection is the recognized solution. LDCT is more and more popular accepted as an effective screening methodology but leads to numerous indeterminate pulmonary nodules for physicians to distinguish too. The value of autoantibody test in risk assessing of IPNs as well as early detection of lung cancer in high risk population has been demonstrated in clinical practice and trial but mainly in Caucasian. Purpose of this study is to understand the sensitivity, specificity and accuracy of candidate autoantibodies, and consequently explore the autoantibody combination with best clinical performance in Chinese population.
- Conditions
- Lung Cancer
- Being tested
- Tumor autoantibody detection
- Keywords
- Tumor Autoantibody, Early Detection, Indeterminate Pulmonary Nodule
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tumor autoantibody detectionDiagnostic test
Level of a set of autoantibodies potentially relative with lung cancer will be tested for each of the participants.
| Study group | Role | What they receive |
|---|---|---|
| Case-Lung Cancer | Patients with definite lung cancer diagnosis Receives: Diagnostic Test: Tumor autoantibody detection | |
| Control | Either patients with benign pulmonary nodule, or healthy individuals without pulmonary nodule but with risk factors to develop lung cancer matched to lung cancer group Receives: Diagnostic Test: Tumor autoantibody detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Autoantibody panel with best clinical performance in Chinese population
The combination which can achieve best sensitivity at 90% specificity, and its sensitivity, accuracy and PPV.
Measured: Oct.30, 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start22 Aug 2019
- Primary completionOct 2020 (estimated)
- Study completionJun 2021 (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.
- 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bai Chunxue
- Sponsor type
- University, hospital or other
- Collaborators
- Gene Tech (Shanghai) Company Limited
- Responsible party
- Sponsor-investigator, Bai Chunxue, Chinese Alliance Against Lung Cancer
- Investigators
- Chunxue Bai, MD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04216511
- Sponsor's protocol ID
- CAALC-007-EarlyCDT Lung China
- Acronym
- ECLC
- Status last verified
- Dec 2019
- First submitted
- 31 Dec 2019
- Last updated
- 2 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinic Validation of Autoantibody Panel for Lung Cancer Diagnosis in Chinese Population
- ClinicalTrials.gov ID
- NCT04216511
- Acronym / sponsor ID
- ECLC / CAALC-007-EarlyCDT Lung China
- Conditions
- Lung Cancer
- Keywords
- Tumor Autoantibody, Early Detection, Indeterminate Pulmonary Nodule
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Bai ChunxueUniversity, hospital or other
- Collaborators
- Gene Tech (Shanghai) Company Limited
- Study start
- 22 Aug 2019 (actual)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 2 Jan 2020 (actual)
- 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.
Lung cancer is the most common cancer in China from both incidence and mortality rate point of view, with significantly lower 5-year survival rate than average. Early detection is the recognized solution. LDCT is more and more popular accepted as an effective screening methodology but leads to numerous indeterminate pulmonary nodules for physicians to distinguish too. The value of autoantibody test in risk assessing of IPNs as well as early detection of lung cancer in high risk population has been demonstrated in clinical practice and trial but mainly in Caucasian. Purpose of this study is to understand the sensitivity, specificity and accuracy of candidate autoantibodies, and consequently explore the autoantibody combination with best clinical performance in Chinese population.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case-Lung Cancer | – | Diagnostic Test: Tumor autoantibody detectionPatients with definite lung cancer diagnosis |
| Control | – | Diagnostic Test: Tumor autoantibody detectionEither patients with benign pulmonary nodule, or healthy individuals without pulmonary nodule but with risk factors to develop lung cancer matched to lung cancer group |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals diagnosed with lung cancer, benign pulmonary nodule or identified as at-risk healthy volunteer in participating hospitals of this study, from the recruitment starting date, till the end of the study.
Key inclusion criteria (7 listed)
- Male or female aged 18 or above.
- Individuals complying with either of the following
- Participant is willing and able to provide necessary information required in CRF.
- Participant is willing and able to give informed consent for participation in the study.
Key exclusion criteria (2 listed)
- History of any cancer;
- Lung cancer patient who received or is receiving any treatment, including but not limited to surgery, radiotherapy, chemotherapy, targeted therapy and immunotherapy.
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 |
|---|---|---|
| Tumor autoantibody detectionLevel of a set of autoantibodies potentially relative with lung cancer will be tested for each of the participants. | Diagnostic test | Case-Lung Cancer, Control |
Primary outcome
Autoantibody panel with best clinical performance in Chinese population
Time frame: Oct.30, 2020
The combination which can achieve best sensitivity at 90% specificity, and its sensitivity, accuracy and PPV.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2020.
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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, MD principal investigator
Fudan University
3 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, run by Bai Chunxue at 3 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 7 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 2 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chunxue Bai, MD (18621170011, bai.chunxue@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Autoantibody panel with best clinical performance in Chinese population (time frame: Oct.30, 2020). 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 2 Jan 2020.