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

NCT05665504 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 250

Last updated 2026-04-01

No results posted yet for this study

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.

Conditions

  • Lung; Node
  • Adenocarcinoma of Lung

Interventions

DIAGNOSTIC_TEST

DetermaRX

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.

Sponsors & Collaborators

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Lary A Robinson, MD · Moffitt Cancer Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-11
Primary Completion
2028-02-29
Completion
2028-02-29
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05665504 on ClinicalTrials.gov