Clinical trial · Interventional

Lung Cancer Screening in Population Who Had Never Smoked

Lung Cancer Screening in Population Who Had Never Smoked and the Validation of Lung Cancer Risk Prediction Model

NCT07383454CI-TRIAL-00102289not yet recruitingN/AClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

Study design: prospective, single arm. Objectives: survey lung cancer detection rate of low-dose computed tomography (LDCT) screening in individuals who had never smoked. Participants will undergo questionnaires, and collecting specimens including blood, urine, and medical informations including results of pulmonary function tests, and LDCT screening upon inclusion. The participants will be followed up according to current standards of clinical practice.

Conditions

Conditions (4)

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 (Diagnosis)	Malignant Lung Neoplasm	CURATED_EXACT	0.85
Non-Small Cell Lung Cancer	Lung Non-Small Cell Carcinoma	ALIAS	0.90
Screening Strategy	—	UNRESOLVED	—
Small Cell Carcinoma of Lung	Lung Small Cell Carcinoma	ALIAS	0.90

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Low dose computed tomography	Diagnostic Test	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
LDCT screening arm
description
LDCT screening, lung function test, and specimens collections
interventionNames
1. Diagnostic Test: Low dose computed tomography

Primary outcomes (1)

measure
Lung cancer detection rate
timeFrame
8 years of follow-up
description
The rate of lung cancer diagnosis during follow up periord.

Secondary outcomes (1)

measure
AUROC of FORMOSA Lung Cancer Risk Prediction Model
timeFrame
8 years
description

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 40 Years
Maximum age: 80 Years

Show eligibility criteria text

Inclusion Criteria:

1. Individuals with no history of smoking.
2. Aged 40 to 80 years.
3. Willing to provide written informed consent and complete questionnaire assessments.
4. After undergoing examinations, willing to provide relevant biological information, including but not limited to: blood samples, urine samples, pulmonary function test results, imaging data, and tissue specimens obtained from invasive biopsies or surgical procedures (if applicable).

Exclusion Criteria:

1. History of lung cancer, or a diagnosis of any malignancy other than skin cancer or cervical carcinoma in situ within the past five years.
2. Undergoing chest computed tomography (CT) scans within the past 18 months.
3. Unexplained hemoptysis within the past one month.
4. Unexplained weight loss exceeding 6 kilograms within the past one year.
5. Pregnancy.

References

Publications (22)

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BACKGROUNDDiaz-Gay M, Zhang T, Hoang PH, Leduc C, Baine MK, Travis WD, Sholl LM, Joubert P, Khandekar A, Zhao W, Steele CD, Otlu B, Nandi SP, Vangara R, Bergstrom EN, Kazachkova M, Pich O, Swanton C, Hsiung CA, Chang IS, Wong MP, Leung KC, Sang J, McElderry JP, Hartman C, Colon-Matos FJ, Miraftab M, Saha M, Lee OW, Jones KM, Gallego-Garcia P, Yang Y, Zhong X, Edell ES, Santamaria JM, Schabath MB, Yendamuri SS, Manczuk M, Lissowska J, Swiatkowska B, Mukeria A, Shangina O, Zaridze D, Holcatova I, Mates D, Milosavljevic S, Kontic M, Bosse Y, Rothberg BEG, Christiani DC, Gaborieau V, Brennan P, Liu G, Hofman P, Yang L, Nowak MA, Shi J, Rothman N, Wedge DC, Homer R, Yang SR, Pesatori AC, Consonni D, Lan Q, Zhu B, Chanock SJ, Choi J, Alexandrov LB, Landi MT. The mutagenic forces shaping the genomes of lung cancer in never smokers. Nature. 2025 Aug;644(8075):133-144. doi: 10.1038/s41586-025-09219-0. Epub 2025 Jul 2.