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Evaluate the Utility of the ProLung China Test in the Diagnosis of Lung Cancer | Clinical Trials | Clareo Health

UNKNOWN

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

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

NCT02726633•Chinese Alliance Against Lung Cancer

View on ClinicalTrials.gov

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

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

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.

Locations (3)

Nantong Tumor Hospital

Nantong, Jiangsu, China

Shanghai Dongfang Hospital of Tongji University

Shanghai, Shanghai Municipality, China

Zhongshan Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

May 1, 2015

Primary Completion Date

December 1, 2017

Completion Date

December 1, 2017

Last Updated

April 4, 2017

Enrollment

500

ESTIMATED participants

Conditions

Solitary Pulmonary NoduleMultiple Pulmonary Nodules

Contacts

Chunxue Bai, MD

CONTACT

18621170011 bai.chunxue@zs-hospital.sh.cn

Dawei Yang, MD

CONTACT

13564703813 yang_dw@hotmail.com

18F-FSPG PET/CT in Imaging Patients With Newly Diagnosed Lung Cancer or Indeterminate Pulmonary Nodules

NCT02448225

Lung CarcinomaSolitary Pulmonary Nodule+1 more

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UNKNOWN

A Real-world Study for Patients With Multiple Pulmonary Ground-glass Nodules

NCT04192201

Multiple Pulmonary Nodules

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 4, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

18F-FSPG PET/CT in Imaging Patients With Newly Diagnosed Lung Cancer or Indeterminate Pulmonary Nodules

A Real-world Study for Patients With Multiple Pulmonary Ground-glass Nodules

Prediction Model for Multiple Pulmonary Nodules

Mobile Lung Nodule Observatory for Worldwide, Evidenced-based Research

Diagnostic Value of Ultralow-dose Computed Tomography for the Detection of Pulmonary Nodules and Lung Parenchym Alterations Compared to Standard-dose CT

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