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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03181490
Other study ID # CCTC1701
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 8, 2017
Est. completion date May 31, 2019

Study information

Verified date March 2020
Source The First Affiliated Hospital of Guangzhou Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Current state-of-the-art lung cancer early screening utilizes low-dose CT scan to identify lung nodules smaller than 3 cm in diameter. However, it's still a clinical challenge to differentiate between malignant and benign nodules.

In previous studies, the investigators had taken the approach of methylation profiling by high throughput bisulfite DNA sequencing in tissue samples to identify specific methylation signatures. The investigators had learned methylation patterns that differentiate malignant vs. benign lesions from tissue samples by in-depth data mining, and then used pattern matching to classify plasma samples.

In this study, the investigators are going to validate the efficacy of ctDNA methylation test for diagnosing early lung cancer by comparing results of the pre-surgery ctDNA methylation test with the post-surgery pathology.


Description:

This is a prospective, multi-center, observational cohort study and seeks to enroll 1230 participants with pulmonary nodules 5-30mm in diameter.

The assay analyzes the ctDNA methylation profiles of lung cancer-specific biomarkers non-invasively using whole blood specimens collected before invasive surgery.

The performance characteristics(sensitivity and specificity) of the pre-surgery ctDNA methylation test for detection of early lung cancer is evaluated in comparison to post-surgery pathology.


Recruitment information / eligibility

Status Completed
Enrollment 1490
Est. completion date May 31, 2019
Est. primary completion date February 28, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 18 years old or above

- single pulmonary nodule found by CT scan.

- the diameter of the pulmonary nodule is between 5mm to 30mm.

- plan to accept pneumonectomy due to the pulmonary nodule.

- without any sign of lymphatic or distant metastasis.

- agree to sign informed consent.

Exclusion Criteria:

- pregnant or lactating women.

- the diameter of the pulmonary nodule is more than 30mm

- there are 2 or more pulmonary nodules in one single patient.

- any sign of lymphatic or distant metastasis

Study Design


Intervention

Diagnostic Test:
Circulating Tumor DNA Methylation Test
Methylation profiling by high-throughput bisulfite DNA sequencing in blood sample to differentiate benign and malignant pulmonary nodules

Locations

Country Name City State
China Department of Thoracic Surgery, Beijing Cancer Hospital Beijing
China Department of Thoracic Surgery, Xuanwu Hospital, Capital Medical University Beijing
China Department of Thoracic Surgery, The Second Xiangya Hospital of Central South University Changsha
China Department of Thoracic Surgery, Xiangya Hospital, Central South University Changsha
China Department of Thoracic Surgery, West China Hospital of Sichuan University Chengdu
China Department of Thoracic Surgery, Nanfang Hospital of Southern Medical University Guangzhou
China Department of Thoracic Surgery, The First Affiliated Hospital of Guangzhou Medical University Guangzhou
China Department of Thoracic Surgery, The First Affiliated Hospital of Sun Yat-sen University Guangzhou
China Department of Thoracic Surgery, The Forth Affiliated Hospital of Harbin Medical University Haerbin
China Department of Thoracic Surgery, Anhui Chest Hospital Hefei
China Department of Thoracic Surgery, The Second Hospital,University of South China Hengyang
China Department of Thoracic Surgery, Qilu Hospital of Shandong University Jinan
China Department of Thoracic Surgery, Jiangsu Province Hospital Nanjing
China Department of Thoracic Surgery, Shenzhen People's Hospital Shenzhen

Sponsors (15)

Lead Sponsor Collaborator
The First Affiliated Hospital of Guangzhou Medical University AnchorDx Medical Co., Ltd., Anhui Chest Hospital, Beijing Cancer Hospital, Central South University, First Affiliated Hospital, Sun Yat-Sen University, Nanfang Hospital of Southern Medical University, Qilu Hospital of Shandong University, Shenzhen People's Hospital, The First Affiliated Hospital with Nanjing Medical University, The Fourth Affiliated Hospital of Harbin Medical University, The Second Hospital University of South China, West China Hospital, Xiangya Hospital of Central South University, Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary The diagnostic performance of the blood-based assay for differentiating benign and malignant pulmonary nodules early using circulating tumor DNA (ctDNA) methylation analysis by next-generation sequencing (NGS) The efficacy of the blood-based ctDNA methylation assay comparing with pathologic diagnosis, the gold standard, including sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV). 1 year
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