Lung NoduleNCT03685669
Non-Invasive ctDNA Methylation Detection for Lung Nodule Patients
An observational study of Lung Nodule, run by Shanghai Chest Hospital at 1 site in China.
Trial summary
Low-dose computed tomography (LDCT) is recommended for early-stage lung cancer screening. However, it is often difficult to determine indolent lesions from more aggressive tumors without an invasive intervention or prolonged follow-up period. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lung Nodule
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2017to Dec 2019
- 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: Adult patients who have single or multiple lung nodules detected by LDCT and are about to undergo surgery; healthy sex and age matched controls
Who may be able to join
- 18 years old or above with pulmonary nodule(s) found by LDCT, mean diameter below 30mm.
- The nodule lesion is peripheral, no signs of lymphatic infiltration or distal metastasis.
- Fit and consent to surgical resection.
- Agree to participate in this study and sign informed consents.
Who cannot join
- Fail to understand or agree to sign informed consent.
- Patients who did not follow the test plan for timely blood collection or did not cooperate with the study follow-up work.
- Patients with previous history of cancer and/or cancer treatment such as surgery, radiotherapy, chemotherapy or targeted therapy.
- Failing to meet the requirements for blood sampling.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030
Ruijun Liu, MD
About this study
Official title: Detection of Early-stage Lung Cancer by Using Methylation Signatures in Circulating Tumor DNA
Low-dose computed tomography (LDCT) is recommended for early-stage lung cancer screening. However, it is often difficult to determine indolent lesions from more aggressive tumors without an invasive intervention or prolonged follow-up period. Thus, the main purpose of this study is to develop a non-invasive method to detect lung-cancer specific circulating tumor DNA (ctDNA) in blood, which can greatly improve the specificity of lung cancer early screening.
Read the detailed description
In this study, the investigators sought to explore sensitive and specific methylation biomarkers that are highly prevalent in lung cancer. It is the first time to perform screening assay on healthy, lung nodule, and lung cancer tissues to identify preliminary set of highly prevalent methylation markers, and then refined these markers by removing regions were unstable in matched plasma samples. Next, investigators interrogated significant methylation marker regions enriched in lung nodules of training sample set to buildup a non-invasive biomarker classification model to discriminate cancerous nodules from benign lesions. Eventually, the model in patient lung nodule samples were validated.
- Conditions
- Lung Nodule
- Keywords
- DNA methylation, ctDNA
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 nodule group | Not described | |
| Healthy Control group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Noninvasive assisted diagnosis of benign and malignant pulmonary nodules
The biomarker classification model can be used to differentiate patients, who had positive LDCT results, with benign or malignant lung nodules.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2018
- Study start1 Jun 2017
- Primary completionJun 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NoduleStudies of the same condition, open and under way.
- More trials run by Shanghai Chest HospitalThe 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
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Singlera Genomics Inc.
- Responsible party
- Principal investigator, Lu Shun, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03685669
- Sponsor's protocol ID
- KS1811
- Status last verified
- Sep 2018
- First submitted
- 10 Sep 2018
- Last updated
- 23 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Early-stage Lung Cancer by Using Methylation Signatures in Circulating Tumor DNA
- ClinicalTrials.gov ID
- NCT03685669
- Acronym / sponsor ID
- KS1811
- Conditions
- Lung Nodule
- Keywords
- DNA methylation, ctDNA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Collaborators
- Singlera Genomics Inc.
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 26 Sep 2018 (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.
Low-dose computed tomography (LDCT) is recommended for early-stage lung cancer screening. However, it is often difficult to determine indolent lesions from more aggressive tumors without an invasive intervention or prolonged follow-up period. Thus, the main purpose of this study is to develop a non-invasive method to detect lung-cancer specific circulating tumor DNA (ctDNA) in blood, which can greatly improve the specificity of lung cancer early screening.
Detailed description
In this study, the investigators sought to explore sensitive and specific methylation biomarkers that are highly prevalent in lung cancer. It is the first time to perform screening assay on healthy, lung nodule, and lung cancer tissues to identify preliminary set of highly prevalent methylation markers, and then refined these markers by removing regions were unstable in matched plasma samples. Next, investigators interrogated significant methylation marker regions enriched in lung nodules of training sample set to buildup a non-invasive biomarker classification model to discriminate cancerous nodules from benign lesions. Eventually, the model in patient lung nodule samples were validated.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lung nodule group | – | – |
| Healthy Control group | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients who have single or multiple lung nodules detected by LDCT and are about to undergo surgery; healthy sex and age matched controls
Key inclusion criteria (4 listed)
- 18 years old or above with pulmonary nodule(s) found by LDCT, mean diameter below 30mm.
- The nodule lesion is peripheral, no signs of lymphatic infiltration or distal metastasis.
- Fit and consent to surgical resection.
- Agree to participate in this study and sign informed consents.
Key exclusion criteria (4 listed)
- Fail to understand or agree to sign informed consent.
- Patients who did not follow the test plan for timely blood collection or did not cooperate with the study follow-up work.
- Patients with previous history of cancer and/or cancer treatment such as surgery, radiotherapy, chemotherapy or targeted therapy.
- Failing to meet the requirements for blood sampling.
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
Noninvasive assisted diagnosis of benign and malignant pulmonary nodules
Time frame: 1 year
The biomarker classification model can be used to differentiate patients, who had positive LDCT results, with benign or malignant lung nodules.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2019.
- Individual participant dataSharing planned: No
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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.
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 Nodule, run by Shanghai Chest Hospital at 1 site 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 4 inclusion and 4 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 23 Jan 2019. 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 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 Liu Ruijun, MD (13917200418, iamliuruijun@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Noninvasive assisted diagnosis of benign and malignant pulmonary nodules (time frame: 1 year). 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 23 Jan 2019.