Liquid Biopsy for Early Screening of Lung CancerNCT06422637
A Prospective Interventional Study on Early Screening for Lung Cancer Using Liquid Biopsy
A study testing Liquid Biopsy Early Screening in people with Liquid Biopsy for Early Screening of Lung Cancer, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial summary
This project aims to establish the MERCURY pilot screening program as part of the "Love Lung Project," employing a novel concept of lung cancer screening with the assistance of low-dose computer tomography (LDCT). Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Liquid Biopsy for Early Screening of Lung Cancer
- What is being tested?
- Liquid Biopsy Early Screening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,944 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age greater than 40 years old and less than 75 years old, regardless of gender.
- Sign the informed consent form.
Who cannot join
- Pregnant women;
- Individuals currently diagnosed with any tumors other than lung cancer, or who have a history of cancer;
- Those who have undergone LDCT/CT screening within the past 1-3 years;
- Individuals currently suffering from a febrile illness, or who have had an acute inflammatory disease episode requiring internal medicine treatment within the last 14 days prior to blood draw;
- Individuals who have taken corticosteroids orally or through intravenous injection within the 14 days prior to blood draw;
- Organ transplant recipients or those who have previously received a non-autologous (allogeneic) bone marrow or stem cell transplant;
- Individuals in poor health or not suitable for blood drawing;
- Any other clinically significant disease or condition considered by the researchers to potentially affect adherence to the protocol, impact the patient's ability to provide informed consent, or render the patient unsuitable for participation in the clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Department of Cardiothoracic Surgery, the First Affiliated Hospital of Guangzhou Medical College
Guangzhou, Guangdong, 510120
About this study
Official title: INFORM: A Prospective Interventional Study on Early Screening for Lung Cancer Using Liquid Biopsy
This project aims to establish the MERCURY pilot screening program as part of the "Love Lung Project," employing a novel concept of lung cancer screening with the assistance of low-dose computer tomography (LDCT). By using clinical pathology as the gold standard, it will parallelly compare the performance (with a sensitivity of ≥90%) of the MERCURY early lung cancer screening model against the LDCT-only screening group within the "Love Lung Project." Ultimately, the objective is to reduce the proportion of overtreatment, achieve earlier staging, and extend patient survival, thus enhancing clinical value.
Read the detailed description
This study is the first international prospective interventional study for lung cancer screening. It designates the "Love Lung Program" using Low-Dose Computed Tomography (LDCT) screening as the control group and the MERCURY screening group as the intervention group. Participants from the general population were enrolled and randomly assigned to either group in a 1:1 ratio. The MERCURY group plans to collect baseline peripheral blood samples from 2,972 individuals for whole genome sequencing (WGS) based on plasma circulating free DNA (cfDNA). This will facilitate a comprehensive analysis of the fragmentomics characteristics of cfDNA. Through the MERCURY early lung cancer screening model, individuals potentially at early stages of lung cancer will be identified. Those showing positive signs will subsequently undergo sequential LDCT to further confirm lung cancer status, eventually confirmed via surgery or pathology. To minimize ethical risks, the negative cases will receive additional LDCT after three months to further confirm their lung status. The control group under the "Love Lung Program" will follow standard LDCT screening procedures with the same number of participants; those with positive LDCT results will undergo clinical diagnosis, while those with negative results will only be followed up for lung status. Relying on the "Love Lung Program," the objective is to establish a new concept of lung cancer screening that precedes with MERCURY screening assisted by LDCT diagnostics.
- Being tested
- Liquid Biopsy Early Screening
- Keywords
- Lung Cancer, Liquid Biopsy
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liquid Biopsy Early ScreeningDiagnostic test
An early screening model for lung cancer aids in identifying individuals with early-stage lung cancer. Those with positive indications of lung cancer will subsequently undergo confirmatory clinical assessments using Low-Dose Computed Tomography (LDCT) in sequence. Ultimately, a definitive diagnosis of lung cancer is established through surgical and pathological examination.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | By collecting 2,972 peripheral blood samples from a natural population baseline, a comprehensive analysis of the fragmentomic characteristics of cfDNA was conducted based on whole-genome sequencing (WGS) of plasma cfDNA. Receives: Diagnostic Test: Liquid Biopsy Early Screening |
| control group | No intervention | 2972 individuals were enrolled from the general population for routine LDCT screening. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive Predictive Value
When a test result indicates that a patient is positive, the probability that the true condition is positive.
Measured: 2 years
Secondary outcomes (1)
Detection rate of non-stage 0 lung cancer within 2 years
the proportion of patients diagnosed with lung cancer through clinical pathology in both the intervention group and the control group.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study start1 Jun 2024 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liquid Biopsy for Early Screening of 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 5,944 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianxing He, The First Affiliated Hospital of Guangzhou Medical University
- Investigators
- Jianxing He, MD, Principal investigator, Department of Medical Oncology of Respiratory, Guangxi Medical University Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06422637
- Sponsor's protocol ID
- ES-2024-025-02
- Status last verified
- May 2024
- First submitted
- 14 May 2024
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: publish an article
Publications
Wang R, Ye Z, Wang Q, Xu R, Feng Y, Zhao N, Yan Y, Zhao Y, Lu X, Zheng X, Zheng J, Deng H, Zhong R, Gao R, Li J, Liang W, He J, Liang H. Dynamic screening initiation using 16 plasma protein biomarkers with polygenic risk and PLCOm2012: a precision prevention framework for lung cancer. J Transl Med. 2025 Dec 23;24(1):218. doi: 10.1186/s12967-025-07468-1.
PubMed 41430273
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INFORM: A Prospective Interventional Study on Early Screening for Lung Cancer Using Liquid Biopsy
- ClinicalTrials.gov ID
- NCT06422637
- Acronym / sponsor ID
- ES-2024-025-02
- Keywords
- Lung Cancer, Liquid Biopsy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 5,944 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 21 May 2024 (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.
This project aims to establish the MERCURY pilot screening program as part of the "Love Lung Project," employing a novel concept of lung cancer screening with the assistance of low-dose computer tomography (LDCT). By using clinical pathology as the gold standard, it will parallelly compare the performance (with a sensitivity of ≥90%) of the MERCURY early lung cancer screening model against the LDCT-only screening group within the "Love Lung Project." Ultimately, the objective is to reduce the proportion of overtreatment, achieve earlier staging, and extend patient survival, thus enhancing clinical value.
Detailed description
This study is the first international prospective interventional study for lung cancer screening. It designates the "Love Lung Program" using Low-Dose Computed Tomography (LDCT) screening as the control group and the MERCURY screening group as the intervention group. Participants from the general population were enrolled and randomly assigned to either group in a 1:1 ratio. The MERCURY group plans to collect baseline peripheral blood samples from 2,972 individuals for whole genome sequencing (WGS) based on plasma circulating free DNA (cfDNA). This will facilitate a comprehensive analysis of the fragmentomics characteristics of cfDNA. Through the MERCURY early lung cancer screening model, individuals potentially at early stages of lung cancer will be identified. Those showing positive signs will subsequently undergo sequential LDCT to further confirm lung cancer status, eventually confirmed via surgery or pathology. To minimize ethical risks, the negative cases will receive additional LDCT after three months to further confirm their lung status. The control group under the "Love Lung Program" will follow standard LDCT screening procedures with the same number of participants; those with positive LDCT results will undergo clinical diagnosis, while those with negative results will only be followed up for lung status. Relying on the "Love Lung Program," the objective is to establish a new concept of lung cancer screening that precedes with MERCURY screening assisted by LDCT diagnostics.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Diagnostic Test: Liquid Biopsy Early ScreeningBy collecting 2,972 peripheral blood samples from a natural population baseline, a comprehensive analysis of the fragmentomic characteristics of cfDNA was conducted based on whole-genome sequencing (WGS) of plasma cfDNA. |
| control group | No intervention | –2972 individuals were enrolled from the general population for routine LDCT screening. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age greater than 40 years old and less than 75 years old, regardless of gender.
- Sign the informed consent form.
Key exclusion criteria (8 listed)
- Pregnant women;
- Individuals currently diagnosed with any tumors other than lung cancer, or who have a history of cancer;
- Those who have undergone LDCT/CT screening within the past 1-3 years;
- Individuals currently suffering from a febrile illness, or who have had an acute inflammatory disease episode requiring internal medicine treatment within the last 14 days prior to blood draw;
- Individuals who have taken corticosteroids orally or through intravenous injection within the 14 days prior to blood draw;
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 |
|---|---|---|
| Liquid Biopsy Early ScreeningAn early screening model for lung cancer aids in identifying individuals with early-stage lung cancer. Those with positive indications of lung cancer will subsequently undergo confirmatory clinical assessments using Low-Dose Computed Tomography (LDCT) in sequence. Ultimately, a definitive diagnosis of lung cancer is established through surgical and pathological examination. | Diagnostic test | Intervention group |
Primary outcome
Positive Predictive Value
Time frame: 2 years
When a test result indicates that a patient is positive, the probability that the true condition is positive.
1 secondary outcome
Detection rate of non-stage 0 lung cancer within 2 years
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Derived from this study: PubMed 41430273Wang R, Ye Z, Wang Q, Xu R, Feng Y, Zhao N, Yan Y, Zhao Y, Lu X, Zheng X, Zheng J, Deng H, Zhong R, Gao R, Li J, Liang W, He J, Liang H. Dynamic screening initiation using 16 plasma protein biomarkers with polygenic risk and PLCOm2012: a precision prevention framework for lung cancer. J Transl Med. 2025 Dec 23;24(1):218. doi: 10.1186/s12967-025-07468-1.
- Individual participant dataSharing planned: No. publish an article
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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.
Jianxing He, MD principal investigator
Department of Medical Oncology of Respiratory, Guangxi Medical University Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liquid Biopsy Early Screening in people with Liquid Biopsy for Early Screening of Lung Cancer, run by The First Affiliated Hospital of Guangzhou Medical University 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 2 inclusion and 8 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: opening soon, as of the sponsor's last update on 21 May 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jianxing He, MD (86-20-83337792, drjianxing.he@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive Predictive Value (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06422637, which also lists 1 linked publication.
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 21 May 2024.