HealthyNCT04156360
Construction and Evaluation of the Liquid Biopsy-based Early Diagnostic Model for Lung Cancer
An observational study of Healthy and Pulmonary Nodule, run by Shanghai Pulmonary Hospital, Shanghai, China.
Trial summary
The purpose of this study is to detetct Circulating tumor cells(CTCs) and Cancer Associated Macrophage-Like cells (CAMLs) in patients with pulmonary nodules using a novel microfluidic CTC-detection system. Then construct an early diagnostic model for lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy, Pulmonary Nodule
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2019to 1 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects with pulmonary nodules diagnosed by chest CT or low-dose computed tomography (LDCT) scans
Who may be able to join
- Female or male, 18 years of age or older
- Pulmonary nodules diagnosed by chest CT or low-dose computed tomography (LDCT) scans
Who cannot join
- Prior diagnosis of lung cancer or other invasive malignancy within the past 5 years
Trial locations and contacts
No sites are listed yet.
About this study
The purpose of this study is to detetct Circulating tumor cells(CTCs) and Cancer Associated Macrophage-Like cells (CAMLs) in patients with pulmonary nodules using a novel microfluidic CTC-detection system. Then construct an early diagnostic model for lung cancer.
Read the detailed description
Patients found pulmonary nodules by CT screening will be enrolled in this study prospectively. CTCs and CAMLs both are cancer specific biomarkers found in the peripheral blood of patients with solid tumors including lung cancer. Through detecting CTCs and CAMLs in healthy volunteers and patients with pulmonary nodules who undergo biopsy, determine the cut-off value of the test. Further analysis of the test specificity and sensitivity, and on this basis construct an early diagnostic model for lung cancer.
- Conditions
- Healthy, Pulmonary Nodule
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 |
|---|---|---|
| Healthy Volunteers | Not described | |
| Patients With Pulmonary Nodule | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of prevalence of CTCs and CAMLs in patients with pulmonary nodules
The number of CTCs and CAMLs will be detected in the peripheral blood of patients with pulmonary nodules using a novel microfluidic CTC-detection system.
Measured: 12 months
Secondary outcomes (1)
Determination of optimal cut-off values for screening Lung Cancer paitents
The optimal cut-off values will be determined by the ROC analyses.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start1 Nov 2019 (estimated)
- Primary completion1 Nov 2020 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Shanghai Pulmonary Hospital, Shanghai, ChinaThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caicun Zhou, Shanghai Pulmonary Hospital, Shanghai, China
- Investigators
- Yayi He, MD, PHD, Principal investigator, Shanghai Pulmonary Hospital, Tongji University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04156360
- Sponsor's protocol ID
- YT2019-001
- Status last verified
- Nov 2019
- First submitted
- 28 Oct 2019
- Last updated
- 7 Nov 2019
- 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 7 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction and Evaluation of the Liquid Biopsy-based Early Diagnostic Model for Lung Cancer
- ClinicalTrials.gov ID
- NCT04156360
- Acronym / sponsor ID
- YT2019-001
- Conditions
- Healthy, Pulmonary Nodule
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, ChinaUniversity, hospital or other
- Study start
- 1 Nov 2019 (estimated)
- Primary completion
- 1 Nov 2020 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 7 Nov 2019 (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.
The purpose of this study is to detetct Circulating tumor cells(CTCs) and Cancer Associated Macrophage-Like cells (CAMLs) in patients with pulmonary nodules using a novel microfluidic CTC-detection system. Then construct an early diagnostic model for lung cancer.
Detailed description
Patients found pulmonary nodules by CT screening will be enrolled in this study prospectively. CTCs and CAMLs both are cancer specific biomarkers found in the peripheral blood of patients with solid tumors including lung cancer. Through detecting CTCs and CAMLs in healthy volunteers and patients with pulmonary nodules who undergo biopsy, determine the cut-off value of the test. Further analysis of the test specificity and sensitivity, and on this basis construct an early diagnostic model for lung cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | – |
| Patients With Pulmonary Nodule | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with pulmonary nodules diagnosed by chest CT or low-dose computed tomography (LDCT) scans
Key inclusion criteria (2 listed)
- Female or male, 18 years of age or older
- Pulmonary nodules diagnosed by chest CT or low-dose computed tomography (LDCT) scans
Key exclusion criteria (1 listed)
- Prior diagnosis of lung cancer or other invasive malignancy within the past 5 years
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
Determination of prevalence of CTCs and CAMLs in patients with pulmonary nodules
Time frame: 12 months
The number of CTCs and CAMLs will be detected in the peripheral blood of patients with pulmonary nodules using a novel microfluidic CTC-detection system.
1 secondary outcome
Determination of optimal cut-off values for screening Lung Cancer paitents
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2019.
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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.
Yayi He, MD, PHD principal investigator
Shanghai Pulmonary Hospital, Tongji University
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy and Pulmonary Nodule, run by Shanghai Pulmonary Hospital, Shanghai, 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 2 inclusion and 1 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 7 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
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 Yayi He, MD, PHD (+862165115006, 2250601@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of prevalence of CTCs and CAMLs in patients with pulmonary nodules (time frame: 12 months). 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 7 Nov 2019.