Clinical trial NCT02726633: Evaluate the Utility of the ProLung China Test in the Diagnosis of Lung Cancer
Official title: Evaluate the Utility of the ProLung China Test as Adjunctive to CT Scan in the Diagnosis of Lung Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Solitary Pulmonary Nodule
Multiple Pulmonary Nodules
Lead sponsor: Chinese Alliance Against Lung Cancer
Sponsor class: OTHER
First posted: 2016-04-04
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects with pulmonary lesions suspicious for lung cancer

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Safety and Efficacy of the ProLung China Test
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Nantong
country: China
facility: Nantong Tumor Hospital
state: Jiangsu
city: Shanghai
country: China
facility: Shanghai Dongfang Hospital of Tongji University
state: Shanghai
city: Shanghai
country: China
facility: Zhongshan Hospital of Fudan University
state: Shanghai
Study officials:
affiliation: Chinese Alliance Against Lung Cancer
name: Chunxue Bai, MD
role: STUDY_CHAIR
References: