Solitary Pulmonary NoduleProLungNCT02726633
Evaluate the Utility of the ProLung China Test in the Diagnosis of Lung Cancer
An observational study of Solitary Pulmonary Nodule and Multiple Pulmonary Nodules, run by Chinese Alliance Against Lung Cancer at 3 sites in China.
Trial summary
A Study to evaluate the utility of the ProLung China Test as an adjunct to CT scan in the diagnosis of lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Solitary Pulmonary Nodule, Multiple Pulmonary Nodules
- How many people
- 500 participants
- Where
- 3 sitesChina
- Study dates
- May 2015to Dec 2017
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with pulmonary lesions suspicious for lung cancer
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
Nantong Tumor Hospital
Nantong, Jiangsu, 226000
Xiaodong Zhang, Master
- Recruiting
Shanghai Dongfang Hospital of Tongji University
Shanghai, Shanghai Municipality, 200000
Tao Ren, MD
Jingjing Lu, Master, 13641791646, lujjhf@163.com
- Recruiting
Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, 200000
Chunxue Bai, MD, 18621170011, bai.chunxue@zs-hospital.sh.cn
Dawei Yang, MD, 13564703813, yang_dw@hotmail.com
About this study
Official title: Evaluate the Utility of the ProLung China Test as Adjunctive to CT Scan in the Diagnosis of Lung Cancer
A Study to evaluate the utility of the ProLung China 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 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.
- Medical subject headings
- Solitary Pulmonary Nodule, Multiple Pulmonary Nodules
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2016 (estimated)
- Study startMay 2015
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Alliance Against Lung Cancer
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bai Chunxue, Chinese Alliance Against Lung Cancer
- Investigators
- Chunxue Bai, MD, Study chair, Chinese Alliance Against Lung Cancer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02726633
- Sponsor's protocol ID
- CAALC-004-Prolung
- Acronym
- ProLung
- Status last verified
- Apr 2017
- First submitted
- 29 Mar 2016
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Utility of the ProLung China Test as Adjunctive to CT Scan in the Diagnosis of Lung Cancer
- ClinicalTrials.gov ID
- NCT02726633
- Acronym / sponsor ID
- ProLung / CAALC-004-Prolung
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Chinese Alliance Against Lung CancerUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 4 Apr 2016 (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 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with pulmonary lesions suspicious for lung cancer
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
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
Safety and Efficacy of the ProLung China Test
Time frame: 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.
Demonstrate safety and efficacy in the risk stratification of patients with pulmonary lesions identified by CT that are suspicious for lung cancer.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
- Individual participant dataSharing planned: Undecided
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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.
Chunxue Bai, MD study chair
Chinese Alliance Against Lung Cancer
3 sites 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 Chinese Alliance Against Lung Cancer at 3 sites in China.
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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chunxue Bai, MD (18621170011, bai.chunxue@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Efficacy of the ProLung China Test (time frame: 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.). 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 4 Apr 2017.