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

Adenocarcinoma of Lung Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05665504
• Other study ID #: MCC-21767
• Status: Recruiting
• Start date: January 11, 2023
• Est. completion date: February 2028

Study information

• Verified date: March 2024
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: Brianna Aponte
• Phone: 813-745-0787
• Email: Brianna.Aponte[@]moffitt.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: February 2028
• Est. primary completion date: February 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma of Lung
• Lung Neoplasms
• Lung; Node
• Recurrence

Intervention

Diagnostic Test:
• DetermaRX
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.

Locations

Country	Name	City	State
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Tumor Malignancy	Fisher exact test will used to test association of both LCDT1™ and NodifyXL2® blood tests with malignancy.	At 6 Months
Secondary	Cancer Recurrence	Fisher exact test will used to test association of LCDT-1™ blood test with cancer recurrence.	At 6 Months

External Links

•   Moffitt Cancer Center Clinical Trial Search