Multiple Pulmonary NodulesNCT03795181
Prediction Model for Multiple Pulmonary Nodules
An observational study of Multiple Pulmonary Nodules, run by Peking University People's Hospital at 1 site in China.
Trial summary
This study compares the sensitivity, specificity and accuracy of radiologists, thoracic surgeons and a predictive model (PKUM model) to discriminate malignancy from benign nodules in patients with multiple pulmonary nodules. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Multiple Pulmonary Nodules
- How many people
- 59 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 30 Mar 2019
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population include patients with multiple pulmonary nodules who will be diagnosed and treated between January 1，2019 and March 30, 2019. Patients with at least 2 nodules resected will be enrolled in this study.
Who may be able to join
- Patients with newly discovered, 4-30 mm multiple pulmonary nodules shown on thoracic CT scans
- Patients with at least two nodules resected for pathological evaluation
Who cannot join
- History of malignancy within 5 years
- Presence of pneumonia or pleural effusion on thoracic CT scans
- Patients with none or only one nodule resected
- Patients with initial chemo-radiation therapy
Trial locations and contacts
1 site in 1 country.
About this study
This study compares the sensitivity, specificity and accuracy of radiologists, thoracic surgeons and a predictive model (PKUM model) to discriminate malignancy from benign nodules in patients with multiple pulmonary nodules.
Read the detailed description
It is clinically difficult to diagnose and manage patients with multiple pulmonary nodules (MPNs). We have developed a web-based mathematic model (PKUM model) by using a multi-centric database from three institutions (Peking University People's Hospital, Haidian Section of Peking University Third Hospital, People's Hospital Affiliated to Hebei Medical University) to predict the probability of a nodule to be malignant in patients with MPNs. This prospectively observational study will recruit patients with MPNs between January 2019 and March 2019, allowing radiologists, surgeons, and a predictive model (PKUM model) to discriminate malignancy from benign nodules, and compare their sensitivity, specificity, and accuracy.
- Conditions
- Multiple Pulmonary Nodules
- Keywords
- multiple pulmonary nodules; predictive model
- Medical subject headings
- Multiple Pulmonary Nodules
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of PKUM model
Area under receiver operating characteristic curve (AUC) of PKUM model in predicting the probability of a nodule to be malignant in patients with multiple pulmonary nodules.
Measured: 3 months
Secondary outcomes (2)
Comparison between PKUM model and clinicians
Comparison of sensitivity and specificity of radiologists, thoracic surgeons, and PKUM model in predicting the probability of a nodule to be malignant in patients with multiple pulmonary nodules.
Measured: 3 months
Performance of PKUM model in equivocal nodules which is difficult to judge by clinicians
Sensitivity and specificity of PKUM model in predicting malignant probability of equivocal nodules judged by radiologists and thoracic surgeons.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2019
- Study start1 Jan 2019
- Primary completion30 Mar 2019
- Study completion30 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Pulmonary NodulesStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Wang, Peking University People's Hospital
- Investigators
- Jun Wang, Principal investigator, Peking University People's HospitalYuqing Huang, Study director, Haidian Section of Peking University Third HospitalJiabao Liu, Study director, People's Hospital Affiliated to Hebei Medical UniversityYingtai Chen, Study director, Beijing Aerospace 711 HospitalMingru Li, Study director, Beijing Aerospace 731 Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03795181
- Sponsor's protocol ID
- PTHO1902
- Status last verified
- Aug 2019
- First submitted
- 1 Jan 2019
- Last updated
- 28 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction Model for Multiple Pulmonary Nodules
- ClinicalTrials.gov ID
- NCT03795181
- Acronym / sponsor ID
- PTHO1902
- Conditions
- Multiple Pulmonary Nodules
- Keywords
- multiple pulmonary nodules; predictive model
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Mar 2019 (actual)
- Study completion
- 30 Mar 2019 (actual)
- First posted
- 7 Jan 2019 (actual)
- 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.
This study compares the sensitivity, specificity and accuracy of radiologists, thoracic surgeons and a predictive model (PKUM model) to discriminate malignancy from benign nodules in patients with multiple pulmonary nodules.
Detailed description
It is clinically difficult to diagnose and manage patients with multiple pulmonary nodules (MPNs). We have developed a web-based mathematic model (PKUM model) by using a multi-centric database from three institutions (Peking University People's Hospital, Haidian Section of Peking University Third Hospital, People's Hospital Affiliated to Hebei Medical University) to predict the probability of a nodule to be malignant in patients with MPNs. This prospectively observational study will recruit patients with MPNs between January 2019 and March 2019, allowing radiologists, surgeons, and a predictive model (PKUM model) to discriminate malignancy from benign nodules, and compare their sensitivity, specificity, and accuracy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population include patients with multiple pulmonary nodules who will be diagnosed and treated between January 1，2019 and March 30, 2019. Patients with at least 2 nodules resected will be enrolled in this study.
Key inclusion criteria (2 listed)
- Patients with newly discovered, 4-30 mm multiple pulmonary nodules shown on thoracic CT scans
- Patients with at least two nodules resected for pathological evaluation
Key exclusion criteria (4 listed)
- History of malignancy within 5 years
- Presence of pneumonia or pleural effusion on thoracic CT scans
- Patients with none or only one nodule resected
- Patients with initial chemo-radiation therapy
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
Performance of PKUM model
Time frame: 3 months
Area under receiver operating characteristic curve (AUC) of PKUM model in predicting the probability of a nodule to be malignant in patients with multiple pulmonary nodules.
2 secondary outcomes
Comparison between PKUM model and clinicians
Time frame: 3 months
Performance of PKUM model in equivocal nodules which is difficult to judge by clinicians
Time frame: 3 months
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 28 Aug 2019.
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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.
Jun Wang principal investigator
Peking University People's Hospital
Yuqing Huang study director
Haidian Section of Peking University Third Hospital
Jiabao Liu study director
People's Hospital Affiliated to Hebei Medical University
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 Multiple Pulmonary Nodules, run by Peking University People's Hospital at 1 site 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 2 inclusion and 4 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 28 Aug 2019. 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 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?
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?
Performance of PKUM model (time frame: 3 months). 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 28 Aug 2019.