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Pilot Study of High Risk Lung Cancer Screening

NCT ID: NCT03683940

Last Updated: 2023-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-10

Study Completion Date

2023-11-09

Brief Summary

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This study is a prospective trial of 200 individuals at high risk for lung cancer who are not eligible for lung cancer screening under current screening guidelines.

Detailed Description

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This study is a prospective trial of 200 individuals at high risk for lung cancer who are not eligible for lung cancer screening under current screening guidelines. Potential subject's 6 yr lung cancer risk must exceed 1.5% by the Tammamagi PLCO2012m calculator. Patients will undergo a non contrast CT chest for lung cancer screening. This cutoff should encompass in excess of 80% of all lung cancer cases (10). However, in patients 78-82 years old we will set the 6 yr lung cancer risk threshold at 4.0% as these patients will typically have other competing risks of death and this may potentially limit screening benefit in these older individuals.

Conditions

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Lung Cancer

Keywords

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Pilot Study High Risk Prospective Screening

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Screening

Subjects will undergo a low dose non contrast CT chest for lung cancer screening.

Group Type OTHER

Screening

Intervention Type DIAGNOSTIC_TEST

Subjects will undergo a low dose non contrast CT chest for lung cancer screening. The test will be performed by the UCH Radiology Department and read by board-certified chest radiologists using Lung-RADS criteria.

Interventions

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Screening

Subjects will undergo a low dose non contrast CT chest for lung cancer screening. The test will be performed by the UCH Radiology Department and read by board-certified chest radiologists using Lung-RADS criteria.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. Adult 40-82 yrs of age.
2. Presenting for lung cancer screening evaluation.
3. Calculated 6 yr lung cancer risk \>1.5% for patients 40-77 years of age or \>4% for patients 78-82 years of age.
4. Able and willing to provide informed consent.

Exclusion Criteria

1. Eligible for clinically indicated lung cancer screening (55-80 yr old, \>30 pky smoking history, still smoking or quit smoking within the last 15 yr).
2. Chest CT performed within the last year.
3. Life expectancy less than 6 months.
4. Symptoms clinically consistent with lung cancer.
5. Unable or unwilling to undergo treatment for lung cancer.
6. Any individual who does not give oral and written consent for participation.
Minimum Eligible Age

40 Years

Maximum Eligible Age

82 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Melissa New, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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University of Colorado Hospital

Denver, Colorado, United States

Site Status

Countries

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United States

References

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Hirsch EA, New ML, Brown SL, Malkoski SP. Results of a pilot risk-based lung cancer screening study: outcomes and comparisons to a Medicare eligible cohort. Discov Oncol. 2023 Aug 29;14(1):160. doi: 10.1007/s12672-023-00773-5.

Reference Type DERIVED
PMID: 37642787 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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15-1694.cc

Identifier Type: -

Identifier Source: org_study_id