- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05572944
Formatting the Risk Prediction Models for Never-Smoking Lung Cancer (FORMOSA)
Validation and Optimization of Multidimensional Modelling for Never Smoking Lung Cancer Risk Prediction by Multicenter Prospective Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
To achieve the goal there are four programs proposed.
Program 1: Validating non-smoker lung cancer prediction model among Taiwanese population: Integration with environmental and occupational factors. The investigators aim to enhance the accuracy of lung cancer prediction among Taiwanese non-smokers by incorporating environmental and occupational risk factors. The main aim of this program is to validate and optimize existing prediction models with more comprehensive epidemiologic, environmental and occupational factors with machine learning algorithms. The other aim is to validate current PM2.5-based lung cancer risk prediction models among nonsmokers, and optimize existing model with environmental and occupational factors in higher resolution. The investigators hypothesize adding more GIS-based environmental exposure measurements, and occupational exposure using job-exposure matrix as proxy can increase the predictive power of lung cancer risk model.
Program 2: Validation of autoantibody- and genetic prediction model for non-smoker lung cancer. The investigators detect the autoantibodies against p53, NY-ESO-1, CAGE, GBU4-5, HuD, MAGE A4 and SOX2 in the blood of recruited patients and detect 133 SNPs and 11 mitochondrial mutations which are highly correlated with never-smoking lung cancer in our preliminary data. The investigators will validate the prediction power of these autoantibodies and genetic biomarkers in the early diagnosis of patients with high risk of acquiring lung cancer in Taiwan.
Program 3: Detection, classification, prediction of lung cancer risk in CT using deep learning and radiomics. The investigators propose an integrated platform for detecting and following up lung nodules. A similarity measurement approach between two nodules is proposed. Base on Lung RADS assessment, the investigators plan to perform CT-radiomic analysis for nodules larger than or equal to 6-8 mm diameter aimed to find nodules in higher risk of developing lung cancer. The lung nodules will be detected and followed up by using a series of AIs. The detected nodules could be used for producing report and estimating Lung-RADS. Though Lung-RADS has considered the risk of malignancy based on their categories, the expectation of this project is to efficiently select CT screen high risk lung nodule(s) by using volume measurement, morphology, texture and CT radiomics of the detected nodules in addition to Lung-RADS criteria based on nodule size and characters.
Program 4: Optimization and validation of lung cancer risk and probability prediction model: prospective multicenter clinical study. The program 4 will first use retrospective cohort based the case control research design to optimize the lung cancer risk models from program 1 and the biomarker and imaging models from program 2 and 3, respectively. The prospective multi-center research design will further use to verify the optimized predictive model. The high-risk participants will be selected to measure for biomarkers and undergo LDCT. The optimized biomarker model and image feature models will be performed to predict the probability of lung cancer and compared it with conventional clinical diagnosis methods and low risk participants. Finally, the Taiwanese population suitable lung cancer screening strategy will be proposed.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: GEECHEN CHANG, MD. PhD
- Phone Number: 34414 +886-4-24739595
- Email: geechen@gmail.com
Study Locations
-
-
-
Hsinchu, Taiwan
- Recruiting
- National Taiwan University Hospital Hsin-Chu Branch
-
Contact:
- Chong-Jen Yu, MD PhD
-
Hualien City, Taiwan
- Recruiting
- Hualien Tzu Chi Hospital
-
Contact:
- Chung-Ping Hsu, MD PhD
-
Kaohsiung, Taiwan
- Recruiting
- Kaohsiung Medical University Chung-Ho Memorial Hospital
-
Contact:
- Inn-Wen Chong, MD PhD
-
Kaohsiung, Taiwan
- Not yet recruiting
- E-DA Hospital
-
Contact:
- Yu-Feng Wei, MD PhD
-
New Taipei City, Taiwan
- Not yet recruiting
- Ministry of Health and Welfare Shuang-Ho Hospital
-
Contact:
- Po-Hao Feng, MD PhD
-
Taichung, Taiwan, 402
- Recruiting
- Chung Shan Medical University Hospital
-
Contact:
- GEECHEN CHANG, MD, PhD
- Phone Number: 34414 +886-4-24739595
- Email: geechen@gmail.com
-
Taipei City, Taiwan, 100229
- Recruiting
- National Taiwan University Hospital
-
Contact:
- Chao-Chi Ho, MD PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age 50-80 years old
First-degree relatives of lung cancer patients
- aged more than 50 - 80 years old
- or older than the age at diagnosis of the youngest lung cancer the proband in the family if they are less than 50 years old
Exclusion Criteria:
- Previous history of lung cancer
- Another malignancy except for cervical carcinoma in situ or non-melanomatous carcinoma of the skin within 5 years
- An inability to tolerate transthoracic procedures or thoracotomy
- Chest CT examination was performed within 18 months
- Hemoptysis of unknown etiology within one month
- Body weight loss of more than 6 kg within one year without an evident cause
- A known pregnancy
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Never smoker with lung cancer high risk assessment
High risk: above the median of the initial risk model from retrospective study
|
Participants will receive the following things in sequence
Other Names:
|
Never smoker with lung cancer low risk assessment
Low risk: below the median of the initial risk model from retrospective study
|
Participants will receive the following things in sequence
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lung cancer detection rate differences between the high lung cancer risk group and the low lung cancer risk group.
Time Frame: 4 years
|
Participants will receive the following things in sequence
|
4 years
|
Predicted Area under curve (AUC) value > 0.8 of the lung cancer risk model
Time Frame: 4 years
|
Through steps 1,2, and 3 of the above column in primary outcome 1, the lung cancer risk model will be developed with optimization and validation of lung cancer risk and probability prediction model by this prospective multicenter study. ( predicted Area under curve (AUC) > 0.8) |
4 years
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MOHW111-TDU-B-221-114019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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