Liquid Biopsy to Reduce Time to Treatment for Advanced Nonsquamous NSCLC Diagnosed at Outside Sites

NCT ID: NCT04474613

Last Updated: 2025-02-05

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

TERMINATED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-27

Study Completion Date

2022-02-10

Brief Summary

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The purpose of this study is to determine if liquid biopsies will reduce time to begin treatment in participants with non-small cell lung cancer (NSCLC). A liquid biopsy is a test done on a sample of blood to look for cancer cells.

Detailed Description

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Referred patients with newly diagnosed NSCLC who have not had genetic testing for targetable mutations will be considered for this study. The primary objective of this prospective study is to examine if using liquid biopsy can reduce time to treatment (TTT) in external participants with NSCLC. Secondary objectives examined will include time to actionable genetic testing results (ctDNA or tissue), rate of actionable biomarker discovery, and rate of appropriate guideline-directed therapy based upon testing results.

A liquid biopsy is a test done on a sample of blood to look for cancer cells. A traditional biopsy, which requires tissue to be removed from the body, takes 14 days to be tested. A liquid biopsy takes 7 days which significantly shortens the TTT for those diagnosed with NSCLC. By studying this, doctors may be better able to determine if this will be beneficial and result in less time taken to treat cancer.

Conditions

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Non Small Cell Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Liquid biopsy

A liquid biopsy is a test will be done on a sample of blood to look for cancer cells

Group Type EXPERIMENTAL

Liquid biopsy

Intervention Type DIAGNOSTIC_TEST

Liquid biopsy done on a blood draw, taking approximately 7 days

Interventions

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Liquid biopsy

Liquid biopsy done on a blood draw, taking approximately 7 days

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Participants with newly diagnosed, advanced nonsquamous NSCLC referred to the Cleveland Clinic Taussig Cancer Center from outside centers without prior testing results available for targetable genetic alterations
* Plan to receive systemic therapy at the Cleveland Clinic, OR plan to receive systemic therapy at an outside site while maintaining either intermittent follow up at Cleveland Clinic or with electronic health record access through Care Everywhere.

Exclusion Criteria

* Prior therapy for this diagnosis of NSCLC
* Prior adequate molecular testing done for the current diagnosis of NSCLC
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Case Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nathan Pennell, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Cleveland Clinic, Case Comprehensive Cancer Center

Locations

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Cleveland Clinic, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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CASE1520

Identifier Type: -

Identifier Source: org_study_id

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