Completed

Clinical Study of BioView Target -FISH Lung Cancer Detection Test

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What is being collected

Data Collection

Collected from today forward - Prospective
No DNA Sample
Who is being recruted

Lung Diseases+5

+ Neoplasms

+ Neoplasms by Site

Over 18 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: April 2012
See protocol details

Summary

Principal SponsorBioview, Inc.
Last updated: July 19, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2012

Actual date on which the first participant was enrolled.

This study is being conducted to evaluate the performance of a laboratory test to detect changes in lung cells that might be an early indicator of lung cancer. The test uses mucus (sputum) which is collected in a non-invasive method. This study will compare the results of the lung biopsy with the laboratory test to determine if the test can detect cancer or the lack of cancer. The laboratory test will not be shared with the treating physician or the patient as the current standard for lung cancer diagnosis is a biopsy. Approximately 330 patients will be enrolled in the study. There is one visit involved and includes the collection of a sputum specimen by coughing into a cup. The medical records of patients who are negative for cancer by biopsy will be reviewed for 2 years to detect any changes in diagnosis. The results of the test will not be provided to the subject, the investigator and will not be used to diagnose or treat the subject.

NCT01700452
Principal SponsorBioview, Inc.
Last updated: July 19, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

173 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Lung DiseasesNeoplasmsNeoplasms by SiteRespiratory Tract DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung NeoplasmsMultiple Pulmonary Nodules

Criteria

4 inclusion criteria required to participate
Ability to understand the investigational nature of the study and sign the informed consent
Candidate is scheduled to undergo lung biopsy procedure to determine clinical diagnosis, such as Bronchoscope biopsy, Electromagnetic Navigation Bronchoscopy, fiber optic Bronchoscopy, Needle biopsy, CT guided, Percutaneous Transthoracic Needle biopsy, Transthoracic Needle Biopsy, Open biopsy for Diagnostic Resection or Video-Assisted Thorascopic Surgery
Candidate who is capable of undergoing sputum induction
Subjects with 0.8-3 cm solitary pulmonary nodules with high probability for malignancy
7 exclusion criteria prevent from participating
Cases without sufficient documentation of diagnosis or follow-up will not be included
Subject who lack the capacity to consent
Subjects already diagnosed with lung cancer, or previously treated for lung cancer
Subjects who experienced an acute respiratory infection within the last 2 weeks
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 6 locations

VA Greater Los Angeles Health System

Los Angeles, United StatesOpen VA Greater Los Angeles Health System in Google Maps

Frederick Memorial Hospital, Regional Cancer Center

Frederick, United States

St. Luke's Hospital

Bethlehem, United States

Kaplan Medical Center

Rehovot, Israel
Completed6 Study Centers