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

NCT02726633 | Unknown DMC

• 1 other identifier: CAALC-004-Prolung
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 3

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.

Conditions

Solitary Pulmonary Nodule; Multiple Pulmonary Nodules

Outcome Measures

Primary Outcomes (1)

• 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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects with pulmonary lesions suspicious for lung cancer

You may qualify if:

• Subject is male or female, age 18 to 80.
• Subject has undergone CT scan of the lung(s) that indicates one or more nodules or lesions.
• 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.
• 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.

You may not qualify if:

• Subject has an implanted electronic device in the chest. Subject receiving therapy for suspected chest infection such as fungal infection or tuberculosis.
• Subject with diagnosed malignancy other than lung cancer who has 2 or more suspicious pulmonary nodules.
• 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.
• Subject presents with an anomalous physical or anatomical condition that precludes ProLung China Test measurement.
• Subject will have undergone unusually strenuous exercise within 24 hours.
• 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.

Sponsors & Collaborators

• Chinese Alliance Against Lung Cancer: lead

Study Sites (3)

Nantong Tumor Hospital

Nantong, Jiangsu, 226000, China

RECRUITING

Shanghai Dongfang Hospital of Tongji University

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Zhongshan Hospital of Fudan University

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

MeSH Terms

Conditions

Solitary Pulmonary Nodule; Multiple Pulmonary Nodules

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms

Study Officials

• Chunxue Bai, MD

  Chinese Alliance Against Lung Cancer

  STUDY CHAIR

Central Study Contacts

Chunxue Bai, MD

CONTACT

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

Dawei Yang, MD

CONTACT

13564703813; yang_dw@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair

Study Record Dates

• First Submitted: March 29, 2016
• First Posted: April 4, 2016
• Study Start: May 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: April 4, 2017

Record last verified: 2017-04

Locations

CN (3)