NCT07854769Toborzás még nem indult
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
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 2.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 200 (tervezett)
- Első benyújtás
- 2026. szept. 28.
- Kezdés
- 2026. okt. 6.
- Elsődleges befejezés
- 2029. okt. 5.
- Fő szponzor
- Fox Chase Cancer Center
- Betegségek
- Tüdőrák
- NCT-szám
- NCT07854769
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Tervezett résztvevők: 200
- 2026. okt. 6. és az elsődleges befejezés (2029. okt. 5.) között
- Nincs megadott helyszín, ország nélkül
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- 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.
Laborértékek
- Patients with tumors are positive for EGFR exon 19 deletion or L858R mutation or ALK or ROS1 gene fusions are excluded.
Egyéb
- 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.
Kiket keres a vizsgálat
- 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.
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket is fogad
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