UnknownNot applicableNCT03236675
Official study title

Detection of Either the EML4-ALK Gene Rearrangements or the T790M EGFR Mutation in the Plasma of Advanced NSCLC Patients

Study summary

Demonstrate feasibility of detection of EML4-ALK fusion transcripts and T790M EGFR mutation from exosomes in the circulation of Non-Small Cell Lung Cancer (NSCLS) patients.

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Key things to know

Main goalNot specified

This describes the study’s primary purpose.

What is being studiedNot specified

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · EGFR · ALK

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 30, 2021 · Source: ClinicalTrials.gov

Is enrollment open?Unknown

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Observational

Where is it offered?2 U.S. locations

Locations may change over time.

Who runs it?Exosome Diagnostics, Inc.

Study sponsor

01
Study overview

What this study is about

Purpose
Not specified
Study type
Observational
Phase
Not applicable
Sponsor
Exosome Diagnostics, Inc.
Interventions being studied
Not specified
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

1. Participants must have histologically confirmed NSCLC, stage IIIB- IV, and have tested positive for the presence of EML4-ALK on tissue specimen, fresh or archived, using an institutionally accepted assay. 2. Age of 18 years or older. 3. Participants are being considered for ALK-directed therapy or have progressed on EGFR TKI treatment. 4. Participants must have hemoglobin \> 10 mg/dL. 5. Ability to understand and willingness to sign a written informed consent document.

Reasons someone may not be able to joinExclusion criteria

1. Hepatitis (all types) in patient's medical record 2. HIV documented in patient's medical record 3. Hemoglobin \< 10 mg/dL 4. Less than 18 years of age 5. Histologically confirmed NSCLC Stage I-IIIA 6. Tested negative for the presence of EML4-ALK and T790M EGFR on tissue

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Memorial Healthcare SystemHollywood, Florida
  • Ochsner Medical CenterNew Orleans, Louisiana

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 30, 2021. Always confirm current availability with the study team.

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