Clinical trial · Interventional
LEGACY: Lung Cancer Screening in Individuals With a Lung Cancer Family History-Protocol A
NCT07685028CI-TRIAL-00116879not yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
This research is being done to determine if an image-based deep learning model (Sybil) can accurately predict the likelihood of future lung cancer based on chest computed tomography (CT) imaging from individuals.
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 |
|---|---|---|---|
| Family History of Lung Cancer | Lung Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CT scan | Diagnostic Test | — | UNRESOLVED |
| Sybil | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Chest CT Scan
- description
- Participants will undergo a single prospective low-dose non-contrast enhanced chest CT within 6 months of study enrollment.
- interventionNames
- Diagnostic Test: CT scan
- Other: Sybil
Primary outcomes (1)
- measure
- Sybil's performance in predicting future lung cancer diagnoses
- timeFrame
- Annually, from time of initial CT scan to up to 5 years after the scan.
- description
- All subjects will be followed for lung cancer diagnosis scan for up to 5 years following the baseline scan. Sybil's performance in predicting future lung cancer diagnoses across the study population will be calculated using the area under the receiver operating curve (AUROC), which is a measure of a risk prediction model's ability to discriminate between cases and controls. Sybil's output corresponds to the cumulative annual risk of lung cancer for up to 6 years following a given scan.
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Age: Must meet both the upper and lower age limit criteria. * Upper age limit: ≤80 years of age * Lower age limit: * ≥40 years of age OR * ≥18 years of age AND ≤10 years of youngest relative's age at time of lung cancer diagnosis (e.g., if a relative was diagnosed at 35 years of age, participant can enroll at ≥25 years of age) * Positive family history of lung cancer (defined as): * Has ≥1 first-degree relative, OR * Has ≥2 second-degree relatives with a diagnosis of non-small cell lung cancer or small cell lung cancer (NB: a first-degree relative = parent, sibling, or child, a second-degree relative = grandparent, blood-related aunt or uncle, grandchild, blood-related niece or nephew, half-sibling) Exclusion Criteria: * Must not have a personal history of lung cancer at the time of enrollment. * Must not have a personal history of stage IV cancer of any type at the time of enrollment. * Must not have had surgical removal of any portion of the lung, excluding needle or core lung biopsy at the time of enrollment. * Must not have had a chest CT within 12 months prior to trial enrollment.
References
Publications (0)
Data not yet available
No reference posted for this study.