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LEGACY: Lung Cancer Screening in Individuals With a Lung Cancer Family History-Protocol B

LEGACY: Lung Cancer Screening in Individuals With a Lung Cancer Family History-Protocol B

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07600801
Enrollment
2250
Registered
2026-05-22
Start date
2026-06-17
Completion date
2035-12-31
Last updated
2026-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Family History of Lung Cancer

Keywords

Screening, CT Scan Images, Lung Cancer

Brief summary

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 with a family history of lung cancer.

Detailed description

This is a non-therapeutic study that will enroll individuals who have a family history of lung cancer. During the study, participants will provide questionnaire responses regarding their personal medical history, family lung cancer history, and exposures along with contributing images from at least one previously obtained CT chest scan. The images and data collected will be analyzed by an image-based deep learning model (Sybil). Sybil is a type of artificial intelligence model that has been shown to accurately predict individuals' future risk of lung cancer based solely on images from a CT Chest scan, but it is unknown if it works well in people with a family history of lung cancer. It is expected that 2,250 will take part in this research study.

Interventions

DIAGNOSTIC_TESTCT scan

Previously obtained computed tomography scan

OTHERSybil

Image-based deep learning model

Sponsors

Massachusetts General Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* ≥18 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) * Willing to provide images from at least one previously obtained CT Chest scan, if available.

Exclusion criteria

\- None

Design outcomes

Primary

MeasureTime frameDescription
Sybil's performance in predicting future lung cancer diagnosesFrom date of receival of retrospective CT scan for up to 2 years.We will estimate future lung cancer diagnoses using the area under the receiver operating curve (AUROC).

Secondary

MeasureTime frameDescription
Distribution of Sybil lung cancer risk scores compared to participants in the NLST clinical trialFrom receival of retrospective CT scan for up to 2 years.We will compare the distribution of Sybil scores between participants in the LEGACY study and National Lung Screening Trial.
Incidence and prevalence of lung cancer in the study populationFrom receival of retrospective CT scan for up to 2 years.We will estimate the incidence of lung cancer in the LEGACY population.
Incidence, prevalence, and characteristics of lung nodules in this populationFrom receival of retrospective CT scan for up to 2 years.We will estimate the incidence, prevalence, and characteristics of lung nodules in the LEGACY population.

Countries

United States

Contacts

CONTACTAllison Chang, MD
aechang@mgb.org617-724-4000
PRINCIPAL_INVESTIGATORAllison Chang, MD

Massachusetts General Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 26, 2026