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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-31

Study Completion Date

2017-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT01958931

Solitary Pulmonary Nodule Multiple Pulmonary Nodules

COMPLETED

Predicting Non-small Cell Lung Cancer (NSCLC) Lymph Node Metastasis: Integrating Circulating Tumor DNA (ctDNA) Mutation/ Methylation Profiling With Positron Emission Tomography-computed Tomography (PET-CT) Scan

NCT06358222

Carcinoma Non-small Cell Lung Cancer

RECRUITING

Early Cancer Detection Test - Lung Cancer China

NCT04216511

Lung Cancer

UNKNOWN

99mTc-H7ND SPECT/CT Imaging in NSCLC

NCT05999214

NSCLC

RECRUITING NA

Deep Learning Signature for Predicting Occult Nodal Metastasis of Clinical N0 Lung Cancer

NCT05425134

Non-small Cell Lung Cancer

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Solitary Pulmonary Nodule Multiple Pulmonary Nodules

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No