NCT07854769Not yet recruiting
Blood Testing to Detect Cancer Recurrence in Patients With Early-Stage Non-Small Cell Lung Cancer
Detection of Molecular Residual Disease in Early-Stage Non-Small Cell Lung Cancer
Source: ClinicalTrials.gov · Last updated 2 Oct 2026
Brief summary (registry, in English)
This observational study will evaluate whether a blood test can detect the return of non-small cell lung cancer at least three months before it is identified on routine imaging. The test measures circulating tumor DNA (ctDNA), which consists of small pieces of DNA released by cancer cells into the blood. Detecting ctDNA after treatment may indicate that cancer cells remain in the body, even when cancer is not visible on scans. Approximately 200 adults with stage IB-IIIA non-small cell lung cancer who are considered candidates for surgery will participate at Fox Chase Cancer Center. Participants will receive standard-of-care treatment selected by their treating physicians, which may include chemotherapy and immunotherapy before or after surgery. Blood samples will be collected before treatment and at scheduled times during treatment and follow-up. Researchers will compare ctDNA results with routine imaging and clinical outcomes to assess how well the test predicts cancer recurrence. Participants will be followed for up to five years after surgery, with the primary analysis focused on the first three years. Additional research in a subset of participants will examine blood, tissue, and stool samples to explore relationships among immune responses, gut bacteria, treatment response, and cancer recurrence.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 28 Sept 2026
- Start date
- 6 Oct 2026
- Primary completion date
- 5 Oct 2029
- Lead sponsor
- Fox Chase Cancer Center
- Diseases
- Lung cancer
- NCT number
- NCT07854769
What you commit to
- Study type: Observational
- Planned participants: 200
- From 6 Oct 2026 to the primary completion date, 5 Oct 2029
- No sites listed in no 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
- Patients must not be currently receiving any other investigational agents or immunomodulatory agents with the exception of drugs used for treatment of rheumatoid arthritis or psoriasis
- Patients with contraindication to chemotherapy or immunotherapy or refuse these treatments.
Lab values
- Patients with tumors are positive for EGFR exon 19 deletion or L858R mutation or ALK or ROS1 gene fusions are excluded.
Other
- Patients who at the discretion of investigators are not suitable for participation.
- Patients who are unable/refuse to participate in blood collection at designated time points.
Who the study is looking for
- Patients must have histologically or cytologically confirmed stage 1B-3A (AJCC 9th edition) non-small cell lung carcinoma regardless of histology.
- Patients must be treatment-naïve.
- Patients must be deemed to be surgical candidates as assessed by their treating physician.
- Age ≥ 18 years.
- Ability to understand and willingness to sign a written informed consent and HIPAA consent document
- Must be willing and able to provide a core tumor biopsy.
- A core tumor biopsy meeting minimum preanalytical requirements is necessary for MRD assay evaluation. The preference is for a sample prior to start of neoadjuvant treatment as roughly 20% of patients will have a complete response and won't have any tumor in the surgical sample. However, if not possible, then sample could come after surgery.
- Patients who go directly to surgery could submit tumor samples after surgery.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.