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RecruitingNot applicableNCT05665504
Official study title

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

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.

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Key things to know

Main goalNot specified

This describes the study’s primary purpose.

What is being studiedDetermaRX

The study team can explain what participation involves.

Who it may be forRecurrent or relapsed

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Apr 1, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Not applicable

Observational

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?H. Lee Moffitt Cancer Center and Research Institute

Study sponsor

01
Study overview

What this study is about

Purpose
Not specified
Study type
Observational
Phase
Not applicable
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Interventions being studied
Diagnostic Test: DetermaRX
02
Explore related studies

How this study is categorized

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

Disease setting
Recurrent or relapsed→
Treatment approach
Surgery→
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
  • 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.
Reasons someone may not be able to joinExclusion 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.

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

  • Moffitt Cancer CenterTampa, Florida

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 1, 2026. Always confirm current availability with the study team.

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