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

NCT05665504 | Recruiting DMC FDA Device

• 1 other identifier: MCC-21767
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung; Node; Adenocarcinoma of Lung

Keywords

Biomarkers; Lung Cancer Biomarkers

Outcome Measures

Primary Outcomes (2)

• Disease Free Survival

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

  Up to 5 years

• Overall Survival

  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.

  Up to 5 Years

Secondary Outcomes (2)

• Tumor Malignancy

  At 6 Months

• Cancer Recurrence

  At 6 Months

Study Arms (3)

High-Risk for Recurrence That Accept Adjuvant Chemotherapy

Participants whose gene assay show that they are at a higher risk of recurrence will be offered to receive postoperative chemotherapy. If participants also have a special mutation on the tumor (EGFR), investigators will recommend that the participant also receive the oral anti-EGFR pill (TagrissoTM) daily for 3 years after completing the chemotherapy. The administration of standard postoperative chemotherapy is not considered part of the study. Only the results of the DetermaRx test is a part of this study.

Diagnostic Test: DetermaRX

High-Risk for Recurrence That Decline Adjuvant Chemotherapy

Participants whose gene assay show that they are at a higher risk of recurrence will be offered to receive postoperative chemotherapy. If participant declines, investigators will followup with participants periodically every 6-12 months over 5 years.

Diagnostic Test: DetermaRX

Low-Risk for Recurrence

Participants whose gene assay show that they are at a lower risk of recurrence will not be offered additional treatment after resection. Investigators will followup with participants periodically every 6-12 months over 5 years.

Diagnostic Test: DetermaRX

Interventions

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.

High-Risk for Recurrence That Accept Adjuvant Chemotherapy; High-Risk for Recurrence That Decline Adjuvant Chemotherapy; Low-Risk for Recurrence

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients seen in the Moffitt Thoracic Surgery and Lung Diagnosis Clinics.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead

Study Sites (1)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

RECRUITING

Related Links

• Moffitt Cancer Center Clinical Trial Search

MeSH Terms

Conditions

Adenocarcinoma of Lung

Condition Hierarchy (Ancestors)

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

Study Officials

• Lary A Robinson, MD

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brianna Aponte

CONTACT

813-745-0787; Brianna.Aponte@moffitt.org

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2022
• First Posted: December 27, 2022
• Study Start: January 11, 2023
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)