RecruitingNCT05665504

Using Biomarkers for Diagnosis, Risk Stratification of Post -Treatment Recurrence and Long-Term Surveillance of Lung Cancer


Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Enrollment

250 participants

Start Date

Jan 11, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

This study is an observational study of blood and tissue biomarkers. Investigators plan to evaluate the accuracy of lung cancer biomarkers found in the blood in determining if a lung nodule is cancer or benign. Investigators also plan to examine another biomarker found in the tumor tissue to identify participants after lung cancer surgery who have a high risk for recurrent cancer. Finally, investigators plan to determine if one of the blood-based biomarkers can be used to detect any late cancer recurrence.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study collects blood samples (liquid biopsies) and tissue from people with early-stage lung cancer before and after treatment, to develop better blood-based tests for detecting cancer recurrence earlier and monitoring long-term outcomes without repeated invasive procedures. **You may be eligible if...** - You are 18 or older - You have a lung nodule between 8–40 mm that is suspected to be an early-stage (Stage IA or IB) lung cancer - You are planning to have surgery or radiation therapy (SBRT) at Moffitt Cancer Center - You are in good health (ECOG 0–1) - You agree to participate in follow-up visits over time **You may NOT be eligible if...** - You are currently receiving any cancer treatment - You have another active major cancer (other than non-melanoma skin cancer) - You had a previous lung cancer diagnosis within the past 5 years - Your lung nodule is a pure ground glass opacity, a suspected carcinoid, a benign tumor, or a metastasis from another cancer - You are incarcerated or unable to give informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTDetermaRX

A lung tissue biomarker to risk stratify patients immediately after curative lung cancer resections into groups with low risk versus intermediate-high risk for recurrence of cancer. Intermediate-high risk patients will be advised to undergo adjuvant chemotherapy with the expectation of decreasing their chance of recurrence. The effectiveness and toxicity of the adjuvant chemotherapy itself is considered not part of the study-just the decision to recommend adjuvant chemotherapy is the study intervention. Investigators will then evaluate the long-term survival results of low-risk patients (no adjuvant treatment) and intermediate-high risk patients receiving adjuvant treatment versus intermediate-high risk patients who decline adjuvant therapy.


Locations(1)

Moffitt Cancer Center

Tampa, Florida, United States

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NCT05665504


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