NCT05699213

Brief Summary

The primary objective of this pilot observational study is to evaluate the accrual and retention rate of a study population from a centralized lung cancer screening program to support MRI and blood-based biomarker research for lung cancer screening.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
4mo left

Started Jun 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Jun 2023Aug 2026

First Submitted

Initial submission to the registry

December 9, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 26, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

June 27, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 27, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 27, 2026

Last Updated

August 30, 2023

Status Verified

August 1, 2023

Enrollment Period

3 years

First QC Date

December 9, 2022

Last Update Submit

August 28, 2023

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Accrual and Retention Rate

    The primary outcome measure is the accrual and retention rate of a study population from a centralized lung cancer screening program to support MRI and blood-based biomarker research.

    3 years

Secondary Outcomes (5)

  • Concordance of Size of Nodules

    3 Years

  • Concordance of Nodule Features: Presence of Calcifications

    3 years

  • Concordance of Nodule Features: Presence of Fat

    3 years

  • Concordance of Nodule Features: Presence of Spiculations

    3 years

  • Concordance of Nodule Features: Solid, Part Solid, Non-Solid

    3 years

Other Outcomes (1)

  • Exploratory Outcomes

    3 years

Interventions

Lung MRIDIAGNOSTIC_TEST

MRI of the lung

Blood DrawDIAGNOSTIC_TEST

Blood Draw

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The primary subject population will be patients who qualify for lung cancer screening based on United States Preventive Services Taskforce (USPSTF) guidelines: Age 50-80 with 20 or greater pack-year smoking history who continue to smoke or have quit within the past 15 years without sign or symptoms of lung cancer. The secondary subject population will be patients who are at increased risk of lung cancer based on National Comprehensive Cancer Network (NCCN) guidelines, but do not meet the USPSTF guidelines

You may qualify if:

  • Ability to read and understand informed consent
  • Male or female adults who are at high risk for lung cancer and are enrolled in the centralized lung cancer screening program: Based on USPSTF guidelines: Age 50-80 with 20 or greater pack-year smoking story who continue to smoke or quit within the past 15 years without sign or symptoms of lung cancer. Or based on National Comprehensive Cancer Network (NCCN) guidelines but do not meet the USPSTF guidelines, age 50-unlimited
  • Found to have one or more lung nodules that is 6mm or greater on screening LDCT

You may not qualify if:

  • Persons with an active diagnosis of cancer
  • Persons with active signs or symptoms of lung cancer
  • Persons with mechanically, magnetically, or electrically activated implants, such as cardiac pacemakers, neurostimulators, and infusion pumps.
  • Persons with ferromagnetic implants and ferromagnetic foreign bodies, such as intracranial aneurysm clips, shrapnel and intraocular metal chips as these could become dislodged.
  • Persons who are pregnant, nursing, are implanted with intrauterine devices (IUD's) that are not MR-compatible
  • Persons unable to tolerate MRI imaging secondary to an inability to lie supine or severe claustrophobia.
  • Persons who are non-compliant with visit instructions, including inability to lie still, hold breath or follow procedure instructions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Sara Ghandehari, MD

    Cedars-Sinai

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Weijia Chua, MD

CONTACT

310-423-1838weijia.chua@cshs.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 9, 2022

First Posted

January 26, 2023

Study Start

June 27, 2023

Primary Completion (Estimated)

June 27, 2026

Study Completion (Estimated)

August 27, 2026

Last Updated

August 30, 2023

Record last verified: 2023-08

Locations

US(1)