Back to search results

Observational Study of Biomarkers for Lung Cancer Diagnosis and Recurrence

This observational study is looking at ways to better diagnose lung cancer and predict if it will come back. Researchers are studying biomarkers, which are substances in your body that can indicate disease. They want to see if biomarkers in your blood can tell if a lung nodule (a small growth) is cancer or not. They are also examining a biomarker called DetermaRX in tumor tissue after surgery to identify patients at high risk for cancer recurrence. Finally, they will investigate if a blood biomarker can detect cancer coming back later. This study is for people aged 18 and older with a suspected lung cancer nodule (8-40 mm) that is potentially removable by surgery. The study aims to understand how these biomarkers relate to how long patients live without the disease returning (Disease Free Survival) and overall survival, both measured for up to 5 years. The current recruitment status is unclear, and the study plans to enroll 250 participants.

Study design
This is an observational study, meaning researchers will collect information without giving any specific treatments. It aims to enroll 250 participants.
What's involved
If you are recommended for surgery, you would undergo surgery at Moffitt Cancer Center. The study involves collecting blood and tissue samples.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 5 years to measure disease-free survival and overall survival.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05665504

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

Recruiting
Not specifiedAges 18+Observational
H. Lee Moffitt Cancer Center and Research Institute
~250 participants
Updated 2026-04-01 on ClinicalTrials.gov
What's tested:DetermaRX

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Disease Free Survival
Measured over Up to 5 years
+1 more outcome measured

Conditions

Lung; Node
Adenocarcinoma of Lung

Explore related trials

Lung Carcinoma

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Lary A Robinson, MD · PRINCIPAL_INVESTIGATOR · Moffitt Cancer Center

Who to contact

Brianna Aponte
[email protected]
813-745-0787
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Disease Free SurvivalUp to 5 years

    Disease-free survival (DFS) is defined as the time from surgical resection and adjuvant chemotherapy to recurrence of tumor or death

  • Overall SurvivalUp to 5 Years

    Overall survival (OS) is defined as the time (days) from the date of surgical resection and adjuvant chemotherapy to the date of death, due to any reason.