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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at markers in blood and tumor tissue in people with a lung spot that may be early lung cancer. It tests whether these markers can show if the spot is cancer, predict the risk of cancer coming back after surgery, and find cancer that returns later.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be older than 18.
  • Have a lung spot 8–40 mm wide that may be removable by surgery, with no diagnosis confirmed before surgery. It must be suspected early lung cancer, under 4 cm, with no signs of spread to nearby lymph nodes.
  • If surgery is recommended, have it at Moffitt Cancer Center.
  • If a tissue test confirms cancer and focused radiation (SBRT) is recommended instead of surgery, have it at Moffitt Cancer Center.
  • Be fully active or able to do light work, with limits only on harder physical activity.
  • Agree to the study’s follow-up plan.
  • Have a suspected cancer that started in the lung, but not a typical carcinoid tumor, cancer limited to its starting layer, or cancer that has grown only slightly into nearby tissue.
  • Be able to understand the study and willing to sign a written consent form.

Who can't join

  • Currently receiving any cancer treatment, or having another illness that is not controlled.
  • Had lung cancer within the past 5 years.
  • Have another active major cancer, except non-melanoma skin cancer.
  • Have a lung spot that looks only hazy on a scan, or a mass where the main airways and blood vessels enter the lung.
  • Have a suspected typical carcinoid tumor, a type of slow-growing lung tumor.
  • Have a lung spot suspected to be cancer that spread from elsewhere in the body.
  • Cannot give informed consent, or are in prison or jail.
  • If having surgery, have cancer left behind that can be seen by eye or under a microscope.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

FL