Clinical trial · Observational
Formatting the Risk Prediction Models for Never-Smoking Lung Cancer
Validation and Optimization of Multidimensional Modelling for Never Smoking Lung Cancer Risk Prediction by Multicenter Prospective Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Lung Cancer is the leading cause of cancer-related deaths in Taiwan and worldwide and the incidence is also increasing. The payment for lung cancer which occupies the largest part of National Health Insurance expense is over 15 billion in 2018. Because about 80% lung cancer patients are smokers in western countries the low-dose computed tomography screening focuses on the smoking population It is quite different in South-East Asia particularly in Taiwan that 53% of Taiwan lung cancer are never-smokers and the etiology and the underlying mechanisms are still unknown. The preliminary results of prospective TALENT study indicated that family history plays a key role in tumorigenesis of Taiwan lung cancers but several important variables such as air pollution, biomarkers, radiomics analysis are not available limits the accuracy of lung cancer identification. Hence, it is critical to integrate most of factors involved in lung cancer formation into a multidimensional lung cancer prediction model which could benefit never-smoker lung cancers in Taiwan and East Asia even in the western countries. The investigators initiate a clinical study to validate the multidimensional lung cancer prediction model for never-smoking population by multicenter prospective study.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LDCT lung cancer screen, immediately | Other | — | UNRESOLVED |
| LDCT lung cancer screen, later | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Never smoker with lung cancer high risk assessment
- description
- High risk: above the median of the initial risk model from retrospective study
- interventionNames
- Other: LDCT lung cancer screen, immediately
- label
- Never smoker with lung cancer low risk assessment
- description
- Low risk: below the median of the initial risk model from retrospective study
- interventionNames
- Other: LDCT lung cancer screen, later
Primary outcomes (2)
- measure
- Lung cancer detection rate differences between the high lung cancer risk group and the low lung cancer risk group.
- timeFrame
- 4 years
- description
- Participants will receive the following things in sequence 1. 10,000 non-smoker participants will receive a prespecified questionnaire 2. Autoantibodies will be checked including p53, NY-ESO-1, CAGE, GBU4-5, HuD, MAGE A4, and SOX2 in the blood of recruited participants. All 133 SNPs and 11 mitochondrial mutations will be detected which are highly correlated with never-smoking lung cancer in our preliminary data 3. In the high-risk group, the investigators will arrange LDCT scans for four rounds to determine the lung cancer detection rate. Also, the pulmonary nodule lesions detected will be classified by Lung-RADS and prediction of lung cancer risk in CT scans using deep learning and radiomics. In the low-risk group, the matched participants will receive LDCT scans for two rounds to determine the lung cancer detection rate.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 50-80 years old 2. 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: 1. Previous history of lung cancer 2. Another malignancy except for cervical carcinoma in situ or non-melanomatous carcinoma of the skin within 5 years 3. An inability to tolerate transthoracic procedures or thoracotomy 4. Chest CT examination was performed within 18 months 5. Hemoptysis of unknown etiology within one month 6. Body weight loss of more than 6 kg within one year without an evident cause 7. A known pregnancy
References
Publications (0)
Data not yet available