Using Biomarkers for Diagnosis, Risk Stratification of Post -Treatment Recurrence and Long-Term Surveillance of Lung Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: DetermaRX.
- Who it may be relevant to
- Registry conditions: Lung; Node, Adenocarcinoma of Lung. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- 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 inter
Primary outcome measures
- Disease Free Survival [Time frame: Up to 5 years]
- Overall Survival [Time frame: Up to 5 Years]
Secondary outcome measures (2)
- Tumor Malignancy [Time frame: At 6 Months]
- Cancer Recurrence [Time frame: At 6 Months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United States · 1 center
- Moffitt Cancer Center — Tampa
Identifiers
NCT: NCT05665504 · MCC-21767