Non-Invasive ctDNA Methylation Detection for Lung Nodule Patients

NCT03685669 | Unknown

• 1 other identifier: KS1811
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Lung Nodule

Keywords

DNA methylation; ctDNA

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Study Arms (2)

Lung nodule group

Healthy Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Chest Hospital: lead
• Singlera Genomics Inc.: collaborator

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

Central Study Contacts

Liu Ruijun, MD

CONTACT

13917200418; iamliuruijun@126.com

Lu Shun, MD

CONTACT

18017321551; shun_lu@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: September 10, 2018
• First Posted: September 26, 2018
• Study Start: June 1, 2017
• Primary Completion: June 1, 2019
• Study Completion: December 1, 2019
• Last Updated: January 23, 2019

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)