Preoperative and Postoperative ctDNA Comparison in Early Stage Lung Cancer

Mutation-positive peripheral blood ctDNA became mutation-negative after surgical removal of the cancer tissue. All subjects in the control group were negative for ctDNA mutations。

Study Overview

• Status: Unknown
• Conditions: Preoperative and Postoperative ctDNA Comparison in Early Stage Lung Cnacer

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• China
  • Jiang Su
    • Suzhou, Jiang Su, China, 215000
      • Recruiting
      • Jianping Gong
      • Contact: Mengqin Xu, Master; Phone Number: 18306202242; Email: xumengqin77@163.com
      • Contact: Jianping Gong, Doctor; Phone Number: 051267783834; Email: gongjianpingsz@162.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The target population comprises all adult patients aged 18 years and older who present with pulmonary nodules.The study sample will include 60 subjects.

Description

Inclusion Criteria:Patients with pulmonary nodules who underwent curative-intent resection were able to enter the study -

Exclusion Criteria:Patients who received any invasive examination or treatment prior to resection or had a history of malignancy; patients who do not attend follow up after surgery; blood samples that were contaminated; and biopsies that exhibited advanced lung cancer in pathology。

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Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The potential value of ctDNA in the diagnosis of NSCLC	The sensitivity,specificity,positive predictive valueand the negative predictive value of mutations in plasma ctDNA for detecting early-stage lung cancer	Half a year

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital of Soochow University
• Investigators: Study Director: Jianping Gong, Doctor, Second Affiliated Hospital of Soochow University

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2018
• Primary Completion (Anticipated): June 30, 2019
• Study Completion (Anticipated): June 30, 2019

Study Registration Dates

• First Submitted: January 12, 2019
• First Submitted That Met QC Criteria: January 12, 2019
• First Posted (Actual): January 15, 2019

Study Record Updates

• Last Update Posted (Actual): January 15, 2019
• Last Update Submitted That Met QC Criteria: January 12, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 12345 (Danish Center for Healthcare Improvements)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No