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出境医 / 临床实验 / Methylation of cfDNA in Diagnosing and Monitoring Pulmonary Nodule
Methylation of cfDNA in Diagnosing and Monitoring Pulmonary Nodule
Study Description
Brief Summary:
Patients found pulmonary nodules by CT screening by will be enrolled in this study prospectively. Plasma cfDNA sequencing of these patients will be used to diagnose and monitor benign and malignant pulmonary nodules.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pulmonary Nodule, Solitary | Procedure: plasma cfDNA methylation | Not Applicable |
Detailed Description:
This study prospectively included patients with pulmonary nodules (0.5-3 cm) diagnosed by CT. Methylation of plasma cfDNA in these patients will be performed. Evaluation of benign and malignant diagnostic efficacy of cfDNA methylation in pulmonary nodules with definite pathological findings. Pulmonary nodules that temporarily not require invasive examination will be performed CT follow-up and dynamically monitored methylation changes of cfDNA. And the methylation changes were to establish a model for the diagnosis and monitor of benign and malignant pulmonary nodules.
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 500 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Diagnostic |
| Official Title: | Methylation of cfDNA in Diagnosing and Monitoring Benign and Malignant Pulmonary Nodule |
| Actual Study Start Date : | August 15, 2018 |
| Estimated Primary Completion Date : | December 15, 2020 |
| Estimated Study Completion Date : | February 15, 2022 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: lung nodules were found by CT scanning
Plasma cfDNA will be performed in patients with pulmonary nodules (0.5-3 cm) found by CT scanning. Evaluation of benign and malignant diagnostic efficacy of cfDNA methylation in pulmonary nodules with clear pathological findings. Pulmonary nodules that could not or temporarily not require invasive examination will be performed CT follow-up and dynamically monitored methylation changes of cfDNA.
|
Procedure: plasma cfDNA methylation
plasma cfDNA will be performed in patients with pulmonary nodules (0.5-3 cm) found by CT scanning. Evaluation of benign and malignant diagnostic efficacy of cfDNA methylation in pulmonary nodules with clear pathological findings. Pulmonary nodules that could not or temporarily not require invasive examination will be performed CT follow-up and dynamically monitored methylation changes of cfDNA.
|
Outcome Measures
Primary Outcome Measures :
- The efficacy of cfDNA methylation in the diagnosis of benign and malignant pulmonary nodules [ Time Frame: 12 months ]The sensitivity, specificity, positive predictive value, negative predictive value and accuracy are calculated according to standard definitions to evaluate the efficacy of cfDNA methylation in the diagnosis of benign and malignant pulmonary nodules .
Eligibility Criteria
| Ages Eligible for Study: | 40 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
-
1. Inclusion criteria:
- Aged 40-80;
- Lung nodules were detected by CT (≥5mm，≤3cm);
- Patients fully understand the informed consent and can sign the informed consent in person.
Exclusion Criteria:
-
2. Exclusion criteria:
- Patients diagnosed with malignant tumors in the past;
- This image suggests pulmonary nodules with hilar or mediastinal lymph node enlargement；
- Pulmonary nodules are suspected of intrapulmonary metastasis of lung cancer or other malignancies；
- Past diseases or conditions that affect plasma cfDNA content, such as rheumatoid immunity and diseases of the blood system.
- The researchers concluded that there were other conditions that made it inappropriate to participate in this study
Contacts and Locations
Contacts
| Contact: Jiayuan Sun, PhD | +86-18017321598 | jysun1976@163.com | |
| Contact: Xiaoxuan Zheng, MD | +86-18918169140 | milozheng@hotmail.com |
Locations
| China, Shanghai | |
| Shanghai Chest Hospital | Recruiting |
| Shanghai, Shanghai, China, 200030 | |
| Contact: Jiayuan Sun, MD jysun1976@163.com | |
| Principal Investigator: Jiayuan Sun, MD | |
| Shanghai Chest Hospital | Recruiting |
| Shanghai, Shanghai, China, 200030 | |
| Contact: Zhonglin Chen | |
Sponsors and Collaborators
Jiayuan Sun
Investigators
| Principal Investigator: | Jiayuan Sun, PhD | Shanghai Chest Hospital |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 16, 2019 | ||||||||
| First Posted Date ICMJE | June 18, 2019 | ||||||||
| Last Update Posted Date | April 30, 2020 | ||||||||
| Actual Study Start Date ICMJE | August 15, 2018 | ||||||||
| Estimated Primary Completion Date | December 15, 2020 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
The efficacy of cfDNA methylation in the diagnosis of benign and malignant pulmonary nodules [ Time Frame: 12 months ] The sensitivity, specificity, positive predictive value, negative predictive value and accuracy are calculated according to standard definitions to evaluate the efficacy of cfDNA methylation in the diagnosis of benign and malignant pulmonary nodules .
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Methylation of cfDNA in Diagnosing and Monitoring Pulmonary Nodule | ||||||||
| Official Title ICMJE | Methylation of cfDNA in Diagnosing and Monitoring Benign and Malignant Pulmonary Nodule | ||||||||
| Brief Summary | Patients found pulmonary nodules by CT screening by will be enrolled in this study prospectively. Plasma cfDNA sequencing of these patients will be used to diagnose and monitor benign and malignant pulmonary nodules. | ||||||||
| Detailed Description | This study prospectively included patients with pulmonary nodules (0.5-3 cm) diagnosed by CT. Methylation of plasma cfDNA in these patients will be performed. Evaluation of benign and malignant diagnostic efficacy of cfDNA methylation in pulmonary nodules with definite pathological findings. Pulmonary nodules that temporarily not require invasive examination will be performed CT follow-up and dynamically monitored methylation changes of cfDNA. And the methylation changes were to establish a model for the diagnosis and monitor of benign and malignant pulmonary nodules. | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Diagnostic |
||||||||
| Condition ICMJE | Pulmonary Nodule, Solitary | ||||||||
| Intervention ICMJE | Procedure: plasma cfDNA methylation
plasma cfDNA will be performed in patients with pulmonary nodules (0.5-3 cm) found by CT scanning. Evaluation of benign and malignant diagnostic efficacy of cfDNA methylation in pulmonary nodules with clear pathological findings. Pulmonary nodules that could not or temporarily not require invasive examination will be performed CT follow-up and dynamically monitored methylation changes of cfDNA.
|
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| Study Arms ICMJE | Experimental: lung nodules were found by CT scanning
Plasma cfDNA will be performed in patients with pulmonary nodules (0.5-3 cm) found by CT scanning. Evaluation of benign and malignant diagnostic efficacy of cfDNA methylation in pulmonary nodules with clear pathological findings. Pulmonary nodules that could not or temporarily not require invasive examination will be performed CT follow-up and dynamically monitored methylation changes of cfDNA.
Intervention: Procedure: plasma cfDNA methylation
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
500 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | February 15, 2022 | ||||||||
| Estimated Primary Completion Date | December 15, 2020 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
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| Ages ICMJE | 40 Years to 80 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | China | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03989219 | ||||||||
| Other Study ID Numbers ICMJE | SHCHE201802 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Jiayuan Sun, Shanghai Chest Hospital | ||||||||
| Study Sponsor ICMJE | Jiayuan Sun | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| PRS Account | Shanghai Chest Hospital | ||||||||
| Verification Date | June 2019 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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