NCT05665504Recruiting
Using Biomarkers for Diagnosis, Risk Stratification of Post -Treatment Recurrence and Long-Term Surveillance of Lung Cancer
Source: ClinicalTrials.gov · Last updated 1 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 250 (estimated)
- First submitted
- 19 Dec 2022
- Start date
- 11 Jan 2023
- Primary completion date
- Feb 2028
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Diseases
- Lung cancer
- NCT number
- NCT05665504
What you commit to
- Study type: Observational
- Planned participants: 250
- From 11 Jan 2023 to the primary completion date, Feb 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants who are actively receiving any cancer treatment.
- Prior lung cancer within 5 years.
- For surgical patients, a R1 or R2 resection.
Other illness
- Participants with uncontrolled intercurrent illness.
- Current active other major cancer except non-melanoma skin cancer.
- Metastatic nodule (suspected) in the lung from an extrapulmonary cancer.
Other
- Patients with pure ground glass opacities (nodules) or hilar masses.
- Suspected typical carcinoid cell type (well-differentiated neuroendocrine carcinoma).
- Patient unable to provide informed consent.
- Prisoner or incarcerated individual.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Moffitt Cancer Center Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.