NCT06854939Toborzás még nem indult
A Prospective Study Investigating the Relationship Between Minimal Residual Disease Detection, Monitoring Frequency, and Prognosis in Non-small Cell Lung Cancer Patients Eligible for Curative Treatment.
Prospective Observational Study Using Personalized Minimal Residual Disease Assay (Signatera) to Evaluate the Kinetics and Detection Rate in Patients with Non-small Cell Lung Cancer
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. márc. 3. · Több mint 12 hónapja nem frissült - kérdezd meg a helyszínt, nyitott-e még
Rövid összefoglaló (regiszter, angolul)
Adding immune checkpoint inhibitors or molecularly targeted drugs as adjuvant therapy to curative treatments-such as surgery or chemoradiotherapy-for stage I-III non-small cell lung cancer (NSCLC) has been established as a standard of care and has improved treatment outcomes. However, there is currently no adequate method to determine which patients should receive these adjuvant therapies. Identifying those with a good prognosis without adjuvant therapy could reduce the risk of adverse events, lessen the burden of clinic visits, and reduce healthcare costs. Among various approaches, ctDNA-based MRD (minimal residual disease) analysis is highly anticipated and has already been introduced into clinical practice for hematologic malignancies. However, solid tumors' development as a companion diagnostic has been limited, and regulatory approval is mainly being considered based on performance evaluation data. In this study, we will conduct a performance evaluation of MRD analysis using Signatera™ in patients with stage I-III NSCLC while also collecting other prognostic factors based on clinicopathological information and survival data.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 350 (tervezett)
- Első benyújtás
- 2025. febr. 25.
- Kezdés
- 2025. márc. 1.
- Elsődleges befejezés
- 2026. szept. 30.
- Fő szponzor
- National Cancer Center, Japan
- Betegségek
- Tüdőrák
- NCT-szám
- NCT06854939
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Tervezett résztvevők: 350
- 2025. márc. 1. és az elsődleges befejezés (2026. szept. 30.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
Szó szerint a(z) ClinicalTrials.gov forrásból, témák szerint csoportosítva. Hogy ki vehet részt, azt csak a vizsgálat csapata dönti el.
Más betegség
- Presence of active multiple primary malignancies (defined as synchronous multiple cancers/tumors or metachronous multiple cancers/tumors with a disease-free interval of 3 years or less). However, even if the disease-free interval is less than 3 years, a history of clinical stage I prostate cancer or a completely resected cancer with any of the pathological stages specified below is not considered "active multiple primary malignancies.
Kiket keres a vizsgálat
- A histopathologically confirmed diagnosis of non-small cell lung cancer (NSCLC)
- The diagnosis (by cytology or biopsy) must be one of the following: "adenocarcinoma," "squamous cell carcinoma," "non-small cell carcinoma consistent with adenocarcinoma," "non-small cell carcinoma consistent with squamous cell carcinoma," or "non-small cell carcinoma not otherwise specified (NOS)." If the histological subtype differs between cytology and biopsy specimens, the subtype determined by the biopsy specimen shall be used.
- At the time of enrollment, diagnoses of "squamous cell carcinoma" or "non-small cell carcinoma consistent with squamous cell carcinoma" are classified as squamous cell carcinoma, whereas "adenocarcinoma," "non-small cell carcinoma consistent with adenocarcinoma," and "non-small cell carcinoma NOS" are classified as non-squamous cell carcinoma.
- Meets one of the following criteria (1-3):
- Stage IB-III (preoperative clinical stage) deemed resectable, with no planned neoadjuvant therapy.
- Stage III disease deemed amenable to curative-intent chemoradiotherapy. 3. Stage II-III (preoperative clinical stage) deemed resectable, with planned neoadjuvant therapy.
- Age ≥ 18 years at the time of enrollment. 4) The attending physician has determined that tissue and blood samples can be provided.
- Written informed consent has been obtained from the patient.
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| National Cancer Center Hospital | Chuo Ku | Japán | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.