Evaluating biomarkers for diagnosing and monitoring lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study focuses on assessing blood and tissue biomarkers to improve the diagnosis and risk stratification of lung cancer. Investigators will evaluate the accuracy of blood biomarkers in distinguishing between cancerous and benign lung nodules. Additionally, they will analyze tumor tissue biomarkers to identify patients at high risk for recurrence after lung cancer surgery. The study also aims to determine if a specific blood-based biomarker can detect late recurrences of cancer.

Why it matters

Who can join: the full rules

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.

Where it's running

• Moffitt Cancer Center
  Tampa, Florida, United States Recruiting

Study contacts

• Principal investigator: Lary A Robinson, MD — Moffitt Cancer Center
• Study coordinator: Brianna Aponte
• Email: Brianna.Aponte@moffitt.org
• Phone: 813-745-0787

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.