Lung CancerNCT05380999
The Red Blood Cells Based Blood Test for Lung Cancer EARLY Detection
An observational study of Lung Cancer and Red Blood Cells, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.
Trial summary
This study plan to enroll 852 patients with pulmonary nodules smaller than 3 cm in diameter, whose DNA and RNA will be extracted from mature red blood cells isolated from peripheral blood. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Red Blood Cells, Methylation
- What is being tested?
- Methylation tests of nucleic acids extracted from mature red blood cells (RBCs)
- How many people
- 852 participants
- Where
- No sites listed yet
- Study dates
- May 2022to Mar 2026
- 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: 1. The pulmonary nodule is ≤30mm as assessed by imaging; nodules were suspected to be malignant, 2. Plan to use biopsy or surgery for diagnosis or treatment within 60 days.
Who may be able to join
- Pulmonary nodule is ≤3cm;
- Subjects suspected of lung cancer;
- Diagnosis or treatment by biopsy or surgery within 60 days;
- Signed informed consent.
Who cannot join
- History of malignant tumors;
- Received anti-tumor therapy;
- Can't collect the histopathological results or the pathological results are metastatic cancer;
- Can't obtain detection information of red blood cells;
- Pregnancy or lactating female；
- Other situations not suitable for the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Training and Validation Study: Development of a Red Blood Cells Based Blood Test for Early Detection of Lung Cancer
This study plan to enroll 852 patients with pulmonary nodules smaller than 3 cm in diameter, whose DNA and RNA will be extracted from mature red blood cells isolated from peripheral blood. The DNA 5-methylcytosine(5-mC) and RNA 2'-O-methylation information will be acquired by NGS and Nm Judge Universally sequencing (NJU-Seq), which will be used to establish models to distinguish patients with benign and malignant nodule in the training group and further evaluated in the validation group. The pathological results will be acquired after surgery or biopsy as standard in the study.
Read the detailed description
This is a prospective, multi-center, observational, cohort study and seeks to enroll 852 participants with pulmonary nodules smaller than 3 cm in diameter from 4 hospitals in China.
Each participant pulmonary nodule is ≤30mm as assessed by CT scanning, nodule is suspected to be malignant, and plan to use biopsy or surgery for diagnosis or treatment within 60 days.Their blood samples, CT scan data, and clinical data will be collected at each visit and tissues will be collected when participants who receive pneumonectomy or percutaneous lung biopsy.
Each subject will analysis DNA and RNA methylation in nucleic acids extracted from mature red blood cells isolated from peripheral blood by next-generation sequencing (NGS) . A proprietary algorithm will be used to identify the modification sites and pattern for differentiating the benign and malignant pulmonary nodules. Sensitivity and specificity of the different methylation panels will be to evaluated.
- Conditions
- Lung Cancer, Red Blood Cells, Methylation
- Being tested
- Methylation tests of nucleic acids extracted from mature red blood cells (RBCs)
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylation tests of nucleic acids extracted from mature red blood cells (RBCs)Diagnostic test
Up to 15 ml of peripheral blood will be collected from each subject, and the blood specimen will be processed to isolate mature red blood cells and extract the DNA and RNA from RBCs. DNA and RNA methylation will be tested by next-generation sequencing (NGS).
| Study group | Role | What they receive |
|---|---|---|
| Patients with pulmonary nodules (diameter ≤3cm) plan to diagnosis benign and malignant | Patients with pulmonary nodules (diameter ≤3cm) plan to use biopsy or surgery or treatment to diagnosis benign and malignant. Receives: Diagnostic Test: Methylation tests of nucleic acids extracted from mature red blood cells (RBCs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of the RBCs-based blood test for differentiating benign and malignant pulmonary nodules diameter less than 3 cm using DNA methylation analysis by NGS.
Measured: 3 years
Specificity of the RBCs-based blood test for differentiating benign and malignant pulmonary nodules diameter less than 3 cm using DNA methylation analysis by NGS.
Measured: 3 years
Positive predictive value (PPV) of the RBCs-based blood test for differentiating benign and malignant pulmonary nodules diameter less than 3 cm using DNA methylation analysis by NGS.
Measured: 3 years
Negative predictive value (NPV) of the RBCs-based blood test for differentiating benign and malignant pulmonary nodules diameter less than 3 cm using DNA methylation analysis by NGS.
Measured: 3 years
Secondary outcomes (5)
Sensitivity of the RBCs-based methylation assay in the invasion of malignant pulmonary nodules.
Measured: 3 years
Specificity of the RBCs-based methylation assay in the invasion of malignant pulmonary nodules.
Measured: 3 years
Area under curve (AUC) of receiver operating characteristic curve (ROC) in the model established in this study will compare with that of Mayo Clinic and Veterans Affairs models.
Measured: 3 years
Sensitivity in the model established in this study will compare with that of Mayo Clinic and Veterans Affairs models.
Measured: 3 years
Specificity in the model established in this study will compare with that of Mayo Clinic and Veterans Affairs models.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study startMay 2022 (estimated)
- Primary completion29 Mar 2025 (estimated)
- Study completionMar 2026 (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.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe 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
- 852 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Peking Union Medical College Hospital, Shanghai Chest Hospital, Guangzhou Panyu Central Hospital, My-BioMed Technology （Guangzhou） Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Tao Wang, MD, Principal investigator, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05380999
- Sponsor's protocol ID
- GL2022-LC001
- Status last verified
- May 2022
- First submitted
- 24 Apr 2022
- Last updated
- 19 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Training and Validation Study: Development of a Red Blood Cells Based Blood Test for Early Detection of Lung Cancer
- ClinicalTrials.gov ID
- NCT05380999
- Acronym / sponsor ID
- GL2022-LC001
- Conditions
- Lung Cancer, Red Blood Cells, Methylation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 852 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Collaborators
- Peking Union Medical College Hospital, Shanghai Chest Hospital, Guangzhou Panyu Central Hospital, My-BioMed Technology （Guangzhou） Co., Ltd.
- Study start
- May 2022 (estimated)
- Primary completion
- 29 Mar 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 19 May 2022 (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 study plan to enroll 852 patients with pulmonary nodules smaller than 3 cm in diameter, whose DNA and RNA will be extracted from mature red blood cells isolated from peripheral blood. The DNA 5-methylcytosine(5-mC) and RNA 2'-O-methylation information will be acquired by NGS and Nm Judge Universally sequencing (NJU-Seq), which will be used to establish models to distinguish patients with benign and malignant nodule in the training group and further evaluated in the validation group. The pathological results will be acquired after surgery or biopsy as standard in the study.
Detailed description
This is a prospective, multi-center, observational, cohort study and seeks to enroll 852 participants with pulmonary nodules smaller than 3 cm in diameter from 4 hospitals in China.
Each participant pulmonary nodule is ≤30mm as assessed by CT scanning, nodule is suspected to be malignant, and plan to use biopsy or surgery for diagnosis or treatment within 60 days.Their blood samples, CT scan data, and clinical data will be collected at each visit and tissues will be collected when participants who receive pneumonectomy or percutaneous lung biopsy.
Each subject will analysis DNA and RNA methylation in nucleic acids extracted from mature red blood cells isolated from peripheral blood by next-generation sequencing (NGS) . A proprietary algorithm will be used to identify the modification sites and pattern for differentiating the benign and malignant pulmonary nodules. Sensitivity and specificity of the different methylation panels will be to evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with pulmonary nodules (diameter ≤3cm) plan to diagnosis benign and malignant | – | Diagnostic Test: Methylation tests of nucleic acids extracted from mature red blood cells (RBCs)Patients with pulmonary nodules (diameter ≤3cm) plan to use biopsy or surgery or treatment to diagnosis benign and malignant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. The pulmonary nodule is ≤30mm as assessed by imaging; nodules were suspected to be malignant, 2. Plan to use biopsy or surgery for diagnosis or treatment within 60 days.
Key inclusion criteria (4 listed)
- Pulmonary nodule is ≤3cm;
- Subjects suspected of lung cancer;
- Diagnosis or treatment by biopsy or surgery within 60 days;
- Signed informed consent.
Key exclusion criteria (6 listed)
- History of malignant tumors;
- Received anti-tumor therapy;
- Can't collect the histopathological results or the pathological results are metastatic cancer;
- Can't obtain detection information of red blood cells;
- Pregnancy or lactating female；
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 |
|---|---|---|
| Methylation tests of nucleic acids extracted from mature red blood cells (RBCs)Up to 15 ml of peripheral blood will be collected from each subject, and the blood specimen will be processed to isolate mature red blood cells and extract the DNA and RNA from RBCs. DNA and RNA methylation will be tested by next-generation sequencing (NGS). | Diagnostic test | Patients with pulmonary nodules (diameter ≤3cm) plan to diagnosis benign and malignant |
Primary outcome
Sensitivity of the RBCs-based blood test for differentiating benign and malignant pulmonary nodules diameter less than 3 cm using DNA methylation analysis by NGS.
Time frame: 3 years
Specificity of the RBCs-based blood test for differentiating benign and malignant pulmonary nodules diameter less than 3 cm using DNA methylation analysis by NGS.
Time frame: 3 years
Positive predictive value (PPV) of the RBCs-based blood test for differentiating benign and malignant pulmonary nodules diameter less than 3 cm using DNA methylation analysis by NGS.
Time frame: 3 years
Negative predictive value (NPV) of the RBCs-based blood test for differentiating benign and malignant pulmonary nodules diameter less than 3 cm using DNA methylation analysis by NGS.
Time frame: 3 years
5 secondary outcomes
Sensitivity of the RBCs-based methylation assay in the invasion of malignant pulmonary nodules.
Time frame: 3 years
Specificity of the RBCs-based methylation assay in the invasion of malignant pulmonary nodules.
Time frame: 3 years
Area under curve (AUC) of receiver operating characteristic curve (ROC) in the model established in this study will compare with that of Mayo Clinic and Veterans Affairs models.
Time frame: 3 years
Sensitivity in the model established in this study will compare with that of Mayo Clinic and Veterans Affairs models.
Time frame: 3 years
Specificity in the model established in this study will compare with that of Mayo Clinic and Veterans Affairs models.
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
- Individual participant dataSharing planned: Undecided
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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.
Tao Wang, MD principal investigator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and Red Blood Cells, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.
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 6 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 19 May 2022. 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 Zichen Jiao, MD (15895905095, zichenjiao@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of the RBCs-based blood test for differentiating benign and malignant pulmonary nodules diameter less than 3 cm using DNA methylation analysis by NGS. (time frame: 3 years). The study lists 4 primary outcomes in all. 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 19 May 2022.