Evaluate the Utility of the ProLung China Test in the Diagnosis of Lung Cancer (ProLung)

Evaluate the Utility of the ProLung China Test as Adjunctive to CT Scan in the Diagnosis of Lung Cancer

A Study to evaluate the utility of the ProLung China Test as an adjunct to CT scan in the diagnosis of lung cancer.

Study Overview

• Status: Unknown
• Conditions: Multiple Pulmonary Nodules; Solitary Pulmonary Nodule

Detailed Description

This Study will assess the stability of the ProLung China Test classification algorithm when used as an adjunct to CT scan. This Study will assess whether there are any potential safety concerns of the ProLung China Test when used to evaluate patients with a positive CT scan for lung cancer.

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Chunxue Bai, MD; Phone Number: 18621170011; Email: bai.chunxue@zs-hospital.sh.cn
• Study Contact Backup: Name: Dawei Yang, MD; Phone Number: 13564703813; Email: yang_dw@hotmail.com

Study Locations

• China
  • Jiangsu
    • Nantong, Jiangsu, China, 226000
      • Recruiting
      • Nantong Tumor Hospital
      • Contact: Xiaodong Zhang, Master
  • Shanghai
    • Shanghai, Shanghai, China, 200000
      • Recruiting
      • Zhongshan Hospital of Fudan University
      • Contact: Chunxue Bai, MD; Phone Number: 18621170011; Email: bai.chunxue@zs-hospital.sh.cn
      • Contact: Dawei Yang, MD; Phone Number: 13564703813; Email: yang_dw@hotmail.com
    • Shanghai, Shanghai, China, 200000
      • Recruiting
      • Shanghai Dongfang Hospital of Tongji University
      • Contact: Tao Ren, MD
      • Contact: Jingjing Lu, Master; Phone Number: 13641791646; Email: lujjhf@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Subjects with pulmonary lesions suspicious for lung cancer

Description

Inclusion Criteria:

1. Subject is male or female, age 18 to 80.
2. Subject has undergone CT scan of the lung(s) that indicates one or more nodules or lesions.
3. Subject's pulmonary nodule or lesion is greater than 4mm and smaller than 50mm. Size is determined by the largest nodule or lesion dimension identified from CT imaging.
4. Subject must be able to receive a ProLung China Test within 30 days of abnormal CT within 14 days prior to the tissue biopsy or surgical resection.

Exclusion Criteria:

1. Subject has an implanted electronic device in the chest. Subject receiving therapy for suspected chest infection such as fungal infection or tuberculosis.
2. Subject with diagnosed malignancy other than lung cancer who has 2 or more suspicious pulmonary nodules.
3. Subject has received an invasive medical or surgical procedure within the thoracic cavity within 30 days prior to the ProLung China Test or within the previous 14 days for a bronchoscopic procedure.
4. Subject presents with an anomalous physical or anatomical condition that precludes ProLung China Test measurement.
5. Subject will have undergone unusually strenuous exercise within 24 hours.
6. Subject who has significant systemic diseases such as uncontrolled diabetes, advanced heart failure, or a recent myocardial infarction, or other medical condition such as severe morbid obesity that in the judgment of the Principal Investigator would make him/her unsuitable for the Study.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and Efficacy of the ProLung China Test	Demonstrate safety and efficacy in the risk stratification of patients with pulmonary lesions identified by CT that are suspicious for lung cancer.	The ProLung China Test will be performed within 30 days of a CT Scan that identifies a lung lesion suspicious for lung cancer and evaluated once a patient diagnosis is obtained.

Collaborators and Investigators

• Sponsor: Chinese Alliance Against Lung Cancer
• Investigators: Study Chair: Chunxue Bai, MD, Chinese Alliance Against Lung Cancer

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: March 29, 2016
• First Submitted That Met QC Criteria: March 29, 2016
• First Posted (Estimate): April 4, 2016

Study Record Updates

• Last Update Posted (Actual): April 4, 2017
• Last Update Submitted That Met QC Criteria: April 1, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Multiple Pulmonary Nodules; Solitary Pulmonary Nodule
• Other Study ID Numbers: CAALC-004-Prolung

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED