In Vitro NSCLC EGFR-Mutant Models for Drug Sensitivity Testing (PRECISE-EGFR)
Targeting EGFR in Lung Cancer: Role of EGFR Mutation State and Bypass Routes in Drug Response and Resistance
The PRECISE-EGFR study is a prospective, observational project designed to generate patient-derived in vitro models (cell cultures and organoids) from individuals with non-small cell lung cancer (NSCLC) carrying EGFR mutations. These models will be used to evaluate sensitivity to different anti-EGFR therapies and explore mechanisms of drug resistance.
Using residual biological samples collected during routine clinical practice, the study will not interfere with patient care. Researchers will also compare the molecular characteristics of the models with the original tumors to ensure reliability.
The overall aim is to improve precision oncology approaches, identifying the most effective treatments for specific EGFR mutation subtypes while minimizing toxicity and resistance.
Studieöversikt
Status
Betingelser
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: EMILIO BRIA, Prof.
- Telefonnummer: +39 0630156318
- E-post: emilio.bria@policlinicogemelli.it
Studera Kontakt Backup
- Namn: Ilaria Marrocco, Doc
- E-post: ilaria.marrocco@unicatt.it
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- Age ≥ 18 years.
- Diagnosis of non-small cell lung cancer (NSCLC), regardless of the line of treatment.
- Documented presence of an EGFR mutation.
- Availability of residual biological material obtained from diagnostic or therapeutic procedures performed as part of routine clinical practice.
- Signed written informed consent for study participation.
Exclusion Criteria:
- Patients who have not provided written informed consent will be excluded from the study.
Studieplan
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Generate in vitro cellular models derived from tumors of patients with NSCLC carrying EGFR mutations, using residual biological samples, to be used for evaluating sensitivity to anti-EGFR drugs.
Tidsram: Throughout the study, 3 years
|
The primary objective is to generate in vitro cellular models derived from tumors of patients with non-small cell lung cancer (NSCLC) harboring EGFR mutations, using residual biological samples, to be used for evaluating sensitivity to anti-EGFR drugs.
|
Throughout the study, 3 years
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Degree of molecular concordance between the original tumor and derived models
Tidsram: Throughout the study, 3 years
|
Compare the molecular characteristics of the obtained models with those of the original tumor in order to verify their biological concordance.
|
Throughout the study, 3 years
|
|
Variation in cell viability in in vitro models following treatment with anti-EGFR drugs
Tidsram: Throughout the study, 3 years
|
To explore, in an exploratory manner, the in vitro response to anti-EGFR drugs in relation to the type of EGFR mutation.
|
Throughout the study, 3 years
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Emlio Bria, Prof, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 27618
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