Clinical trial · Observational
Using Biomarkers for Diagnosis, Risk Stratification of Post -Treatment Recurrence and Long-Term Surveillance of Lung Cancer
NCT05665504CI-TRIAL-00107048recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma of Lung | Lung Adenocarcinoma | ALIAS | 0.90 |
| Lung; Node | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DetermaRX | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- High-Risk for Recurrence That Accept Adjuvant Chemotherapy
- description
- 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.
- interventionNames
- Diagnostic Test: DetermaRX
- label
- High-Risk for Recurrence That Decline Adjuvant Chemotherapy
- description
- 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.
- interventionNames
- Diagnostic Test: DetermaRX
- label
- Low-Risk for Recurrence
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.