Solitary Pulmonary NoduleNCT01958931
Evaluate the Utility of the ProLung Test as Adjunctive to CT Scan in the Diagnosis of Lung Cancer
An observational study of Solitary Pulmonary Nodule and Multiple Pulmonary Nodules, run by Fresh Medical Laboratories at 1 site in United States.
Trial summary
A Study to evaluate the utility of the ProLung Test as an adjunct to CT scan in the diagnosis of lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solitary Pulmonary Nodule, Multiple Pulmonary Nodules
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Jan 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with lung cancer symptoms and pulmonary lesions suspicious for lung cancer
Who may be able to join
- Subject is male or female, age 18 or above.
- If female, subject
- is of non-childbearing potential meaning permanently sterile, or
- is one year post-menopausal; or
- is not pregnant as confirmed by negative urine pregnancy test and using adequate birth control at time of screening.
- Subject presents with one or more of the following clinical symptoms or suspicious radiological finding(s):
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- Persistent cough
- Hoarseness
- Shortness of breath
- Sputum streaked with blood
- Fatigue
- Unexplained recent weight loss
- Recurrent pneumonia or bronchitis
- Chest pain
- Abnormal chest radiograph
- Subject has undergone a CT scan of the lungs within 44 days of measurement that indicates one or more non-calcified nodules (NCN) or lung masses suspicious for lung cancer.
- Subject is capable of understanding and agreeing to fulfill the requirements of this protocol.
- Subject has signed the IRB/IEC approved informed consent form.
Who cannot join
- Subjects who meet one or more of the following criteria may not be enrolled in this Study:
- Subject has a pacemaker or other implanted electronic device.
- Subject with diagnosed malignancy within the past 5 (five) years except for non-melanoma skin cancer.
- Subject with significant systemic diseases including uncontrolled diabetes, severe heart failure, uncontrolled hypertension, myocardial infarction and/or auto-immune conditions within the prior 3 (three) months.
- Subject taking systemic corticosteroid medication (except for inhaled) within 14 days prior to measurement session.
- Subject has had an invasive medical procedure that involves the thoracic cavity within 30 days prior to the measurement session.
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- Subject who currently abuses alcohol or drugs.
- Subject presents with an anomalous physical or anatomical condition that precludes measurement.
- Subject will have undergone unusually strenuous exercise within 24 hours prior to measurement session.
- Subject who has, in the Principal Investigator's opinion, any medical condition or other circumstance that would prevent completion of this Study or interfere with analysis of the Study results.
- Subjects who have undergone radiation and chemotherapy treatment within the past 30 days.
- Subject receiving therapy for documented or suspected chest infection.
- Pregnant or lactating females.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins School of Medicine
Baltimore, Maryland, 21205
About this study
A Study to evaluate the utility of the ProLung Test as an adjunct to CT scan in the diagnosis of lung cancer.
Read the detailed description
This Study will assess the stability of the ProLung 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 Test when used to evaluate patients with a positive CT scan for lung cancer.
- Medical subject headings
- Solitary Pulmonary Nodule, Multiple Pulmonary Nodules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients Suspicious for Lung Cancer | Subjects are symptomatic of lung cancer and have one or more lung nodules or lung masses suspicious for lung cancer. |
What is being measured
The primary outcome is the main question the study is designed to answer.
ProLung Test utility in lung cancer
This Study will assess the stability of the ProLung Test classification algorithm when used as an adjunct to CT scan to determine whether it is appropriate to be used in a pivotal study.
Measured: date of conclusive diagnosis
Secondary outcomes (1)
Safety and Tolerability of the ProLung Test
This Study will assess whether there are any potential safety concerns of the ProLung Test when used to evaluate patients with a positive CT scan for lung cancer.
Measured: within 30 minutes of the ProLung Test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2013 (estimated)
- Study startSep 2007
- Primary completionNov 2008
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solitary Pulmonary NoduleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fresh Medical Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01958931
- Sponsor's protocol ID
- FML - 204
- Status last verified
- Oct 2013
- First submitted
- 7 Oct 2013
- Last updated
- 9 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Utility of the ProLung Test as Adjunctive to CT Scan in the Diagnosis of Lung Cancer
- ClinicalTrials.gov ID
- NCT01958931
- Acronym / sponsor ID
- FML - 204
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Fresh Medical LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Nov 2008 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 9 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Study to evaluate the utility of the ProLung Test as an adjunct to CT scan in the diagnosis of lung cancer.
Detailed description
This Study will assess the stability of the ProLung 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 Test when used to evaluate patients with a positive CT scan for lung cancer.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients Suspicious for Lung Cancer | – | –Subjects are symptomatic of lung cancer and have one or more lung nodules or lung masses suspicious for lung cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with lung cancer symptoms and pulmonary lesions suspicious for lung cancer
Key inclusion criteria (18 listed)
- Subject is male or female, age 18 or above.
- If female, subject
- Subject presents with one or more of the following clinical symptoms or suspicious radiological finding(s):
- Subject has undergone a CT scan of the lungs within 44 days of measurement that indicates one or more non-calcified nodules (NCN) or lung masses suspicious for lung cancer.
- Subject is capable of understanding and agreeing to fulfill the requirements of this protocol.
Key exclusion criteria (13 listed)
- Subjects who meet one or more of the following criteria may not be enrolled in this Study:
- Subject has a pacemaker or other implanted electronic device.
- Subject with diagnosed malignancy within the past 5 (five) years except for non-melanoma skin cancer.
- Subject with significant systemic diseases including uncontrolled diabetes, severe heart failure, uncontrolled hypertension, myocardial infarction and/or auto-immune conditions within the prior 3 (three) months.
- Subject taking systemic corticosteroid medication (except for inhaled) within 14 days prior to measurement session.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ProLung Test utility in lung cancer
Time frame: date of conclusive diagnosis
This Study will assess the stability of the ProLung Test classification algorithm when used as an adjunct to CT scan to determine whether it is appropriate to be used in a pivotal study.
1 secondary outcome
Safety and Tolerability of the ProLung Test
Time frame: within 30 minutes of the ProLung Test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Solitary Pulmonary Nodule and Multiple Pulmonary Nodules, run by Fresh Medical Laboratories at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ProLung Test utility in lung cancer (time frame: date of conclusive diagnosis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2013.