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

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

Recruiting
18 years and older
All
Phase N/A

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Overview

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

Inclusion Criteria:

  • Potentially-resectable lung nodule 8-40 mm diameter suspected (no preop diagnosis) of being a clinically node-negative lung cancer [clinical stage IA-IB (cT1a-T2aN0), <4cm diameter].
  • If surgical resection is recommended, patient will undergo surgery at Moffitt Cancer Center.
  • If a definite tissue diagnosis is obtained and stereotactic body radiotherapy (SBRT) is the recommended treatment instead of surgery, the SBRT will be delivered at Moffitt Cancer Center.
  • >18 years old, male or female.
  • ECOG performance status 0-1.
  • Agree to participate in the follow-up protocol.
  • Any suspected primary lung cancer cell type (except a suspected typical carcinoid tumor, carcinoma in situ or minimally-invasive carcinoma).
  • Ability to understand and the willingness to sign a written, informed consent document.

Exclusion Criteria:

  • Participants who are actively receiving any cancer treatment.
  • Participants with uncontrolled intercurrent illness.
  • Prior lung cancer within 5 years.
  • Current active other major cancer except non-melanoma skin cancer.
  • Patients with pure ground glass opacities (nodules) or hilar masses.
  • Suspected typical carcinoid cell type (well-differentiated neuroendocrine carcinoma).
  • Metastatic nodule (suspected) in the lung from an extrapulmonary cancer.
  • Patient unable to provide informed consent.
  • Prisoner or incarcerated individual.
  • For surgical patients, a R1 or R2 resection.

Study details
    Lung; Node
    Adenocarcinoma of Lung

NCT05665504

H. Lee Moffitt Cancer Center and Research Institute

27 January 2024

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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