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

Solitary Pulmonary Nodule Clinical Trial

— ProLung  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02726633
• Other study ID #: CAALC-004-Prolung
• Status: Recruiting
• Phase: N/A
• First received: March 29, 2016
• Last updated: April 1, 2017
• Start date: May 2015
• Est. completion date: December 2017

Study information

• Verified date: April 2017
• Source: Chinese Alliance Against Lung Cancer
• Contact: Chunxue Bai, MD
• Phone: 18621170011
• Email: bai.chunxue[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Pulmonary Nodules
• Solitary Pulmonary Nodule

Locations

Country	Name	City	State
China	Nantong Tumor Hospital	Nantong	Jiangsu
China	Shanghai Dongfang Hospital of Tongji University	Shanghai	Shanghai
China	Zhongshan Hospital of Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Alliance Against Lung Cancer

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.