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NCT Number: NCT05665504

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

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.

Recruiting

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Key information

Conditions

Lung; Node Adenocarcinoma Adenocarcinoma of Lung Carcinoma Lung Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location status: Recruiting

Location contact

Brianna Aponte

CONTACT

[email protected]

813-745-0787

Lary A Robinson, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DetermaRX

Diagnostic Test

A lung tissue biomarker to risk stratify patients immediately after curative lung cancer resections into groups with low risk versus intermediate-high risk for recurrence of cancer. Intermediate-high risk patients will be advised to undergo adjuvant chemotherapy with the expectation of decreasing their chance of recurrence. The effectiveness and toxicity of the adjuvant chemotherapy itself is considered not part of the study-just the decision to recommend adjuvant chemotherapy is the study intervention. Investigators will then evaluate the long-term survival results of low-risk patients (no adjuvant treatment) and intermediate-high risk patients receiving adjuvant treatment versus intermediate-high risk patients who decline adjuvant therapy.

Primary outcomes

  1. Disease Free Survival

    Time frame: Up to 5 years

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

  2. Overall Survival

    Time frame: Up 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.

Secondary outcomes

  1. Tumor Malignancy

    Time frame: At 6 Months

    Fisher exact test will used to test association of both LCDT1™, NodifyXL2®, and CIZ1b™ blood tests with malignancy.

  2. Cancer Recurrence

    Time frame: At 6 Months

    Fisher exact test will used to test association of LCDT-1™ blood test with cancer recurrence.

Study contacts

Contact information is provided by the study sponsor or research team.

Brianna Aponte

CONTACT

[email protected]

813-745-0787

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Registry information

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Dec 27, 2022
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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