Patient-Specific MRD Liquid Biopsy in Resected NSCLC: Plasma and Bronchial Washing ctDNA
A legfontosabb adatok
- Ki végzi
- Eun Hye Lee
- Hol
- Seoul és Yongin-si (Dél-Korea)Mind a 3 helyszín megnézése
- Azonosító
- NCT07921888
- KCT0012574
- Állapot
- Toboroz
- Résztvevők
- 40 fő, tervezett
- Kezdés
- 2026. szept. 28.
- Várható befejezés
- 2031. dec. 31.
- A vizsgálat típusa
- Megfigyeléses
- A vizsgált kezelések
- Patient-specific tumor-informed MRD assay (plasma and bronchial washing ctDNA)
- Bronchoscopy with bronchial washing for reserach
- A regiszteradat frissítve
- 2026. november 12.
Ki vehet részt
- Életkor
- 19 év felett
- Nem
- Nők és férfiak
- Egészséges önkéntesek
- Nem vehetnek részt
A regiszter feltételei, szó szerint
Mind a 11 feltétel megnézéseKevesebb
Ki vehet részt
- Adults aged 19 years or older
- Pathologically confirmed non-small cell lung cancer who underwent curative-intent complete (R0) surgical resection
- Final pathologic stage IA3 (tumor size >2 cm) to IIIA after surgery
- Able to attend the first outpatient visit within 1 month after surgery, and agrees to research blood sampling, provision of surgical tissue slides, and long-term follow-up
- Provided voluntary written informed consent after adequate explanation of the study purpose and methods
Ki nem vehet részt
- Incomplete resection (non-R0) or clear residual tumor after surgery
- History of other malignancy, including synchronous malignancy in another organ, that may confound interpretation of MRD results (cancers judged cured for more than 5 years may be included)
- Poor performance status or other conditions making repeated blood sampling or bronchoscopy difficult
- Pathologic stage IA1 or IA2 (tumor size ≤2 cm), stage IV, or confirmed distant metastasis
- Unstable cardiopulmonary function, or high risk with sedation or additional procedures, in the judgment of the treating physician
- Unable to provide informed consent, or judged unable to comply with regular follow-up during the study period
Helyszínek itt: Dél-Korea
- Gangnam Severance HospitalSeoul, Dél-KoreaContact: KIM Chiyoung, Ph.D.Course of Medical ScienceToborzás még nem indult
- Severance hospitalSeoul, Dél-KoreaContact: YONG Seunghyun, Ph.D.Course of Medical ScienceToborzás még nem indult
- Yongin Severance HospitalYongin-si, Dél-KoreaContact: LEE Eunhye, Ph.D.Course of Medical ScienceRésztvevőt keres
A vizsgálatról
Mit akar kideríteni a vizsgálat
This is a multicenter, prospective, observational pilot cohort study in patients with surgically resected non-small cell lung cancer (NSCLC, pathologic stage IA3-IIIA). Whole exome sequencing (WES) of each patient's resected tumor tissue and matched normal blood is used to build a patient-specific (tumor-informed) minimal residual disease (MRD) panel, after excluding germline and clonal hematopoiesis variants. MRD is then assessed in paired plasma circulating tumor DNA (ctDNA) and bronchial washing fluid (BWF) ctDNA collected at 6, 12, 18 and 24 months after surgery. The study evaluates whether MRD positivity in plasma and/or BWF is associated with subsequent clinical or radiologic recurrence, compares MRD detection rates and quantitative values between plasma and BWF, and explores the lead time of MRD detection relative to standard surveillance with chest CT and serum CEA. MRD results are not used to confirm recurrence or to change treatment; all clinical decisions follow standard of care. Forty participants will be enrolled at three Severance hospitals in Korea.
A vizsgálat csoportja
- Resected NSCLC (stage IA3-IIIA)
Adults who underwent curative-intent (R0) resection for pathologic stage IA3-IIIA NSCLC. Participants undergo patient-specific MRD panel construction and serial plasma and BWF MRD testing at 6, 12, 18 and 24 months after surgery.
Kezelés: Patient-specific tumor-informed MRD assay (plasma and bronchial washing ctDNA) és Bronchoscopy with bronchial washing for reserach
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakAdatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- Development of a Patient-Specific MRD Liquid Biopsy Platform in Resected NSCLC: Combined Analysis of Plasma and Bronchial Washing ctDNA
- A regiszteradat frissítve
- 2026. november 12.