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NCT05665504 | RECRUITING | Lung; Node

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

H. Lee Moffitt Cancer Center and Research Institute

Brief 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.

Condition or disease

Lung; Node

Adenocarcinoma of Lung

Intervention/treatment

DetermaRX

Study Type : OBSERVATIONAL
Estimated Enrollment : 250 participants
Official Title : Using Biomarkers for Diagnosis, Risk Stratification of Post -Treatment Recurrence and Long-Term Surveillance of Lung Cancer
Actual Study Start Date : 2023-01-11
Estimated Primary Completion Date : 2028-02
Estimated Study Completion Date : 2028-02

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
Using Biomarkers for Diagnosis, Risk Stratification of Post -Treatment Recurrence and Long-Term Surveillance of Lung Cancer

Location Details

NCT05665504

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How to Participate

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Locations

RECRUITING

United States, Florida

Moffitt Cancer Center

Tampa, Florida, United States, 33612