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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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The HEROS study is an Italian observational multicenter prospective study aimed to investigate the current diagnostic and therapeutical approach towards HER2 mutated NSCLC in clinical practice. The enrolment will start in September 2024 until September 2025. A 12-months follow-up window will be performed.
The HEROS study will be conducted in partnership with ATLAS project: all patients prospectively enrolled in ATLAS project will be used to fulfil primary and secondary objectives. Information will be obtained by querying ATLAS database (59 centers) in aggregated manner. ATLAS project is a multi-centric retrospective/prospective Italian study aimed to describe prevalence of different oncogene alterations in all new diagnosed advanced NSCLC patients (5,000 patients/year). In particular, prevalence of HER2-mutated patients will be calculated on all patients enrolled in ATLAS project. Approximately 100 HER2 mutated patients enrolled in ATLAS study will be studied for secondary and explorative objectives. Moreover, a subset of centers (25 centers) will enrol patients also for Prospective Biomarker Analysis in order to perform exploratory analysis on blood and tissue samples according to the availability of tissue specimens from the primary tumor or metastatic sites. All centers that will participate for Prospective Biomarker Analysis necessarily will be included into ATLAS project.
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| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of HER2 mutation | Percentage of advanced NSCLC with HER2 mutations in Italy clinical practice. | 1 year |
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Inclusion Criteria:
Cohort 1 (Prevalence study population)
Exclusion Criteria:
-
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Patients with HER2-mutated advanced non-small cell lung cancer
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marcello Tiseo, MD, PhD | Contact | +390521704465 | goirc-heros@goirc.org | |
| Alessandro Leonetti, MD, PhD | Contact | info@goirc.org |
| Name | Affiliation | Role |
|---|---|---|
| Marcello Tiseo, MD, PhD | Gruppo Oncologico Italiano di Ricerca Clinica | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS "Giovanni Paolo II" | Active, not recruiting | Bari | BA | 70124 | Italy | |
| Istituto Romagnolo per lo Studio dei Tumori IRST "Dino Amadori" |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 2, 2024 |
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FFPE material and blood
| Not yet recruiting |
| Meldola |
| FC |
| 47014 |
| Italy |
|
| Arcispedale Sant'Anna | Not yet recruiting | Ferrara | FE | 44124 | Italy |
|
| Ospedale Policlinico San Martino | Not yet recruiting | Genova | GE | 16132 | Italy |
|
| Ospedale Versilia | Active, not recruiting | Lido di Camaiore | LU | 55041 | Italy |
| Azienda Sanitaria Toscana Nord - Ovest | Active, not recruiting | Lucca | LU | 55100 | Italy |
| IRCCS San Gerardo dei Tintori | Not yet recruiting | Monza | MB | 20900 | Italy |
|
| IRCCS Ospedale San Raffaele | Not yet recruiting | Milan | MI | 20132 | Italy |
|
| ASST Grande Ospedale Metropolitano Niguarda | Not yet recruiting | Milan | MI | 20162 | Italy |
|
| Istituto Clinico Humanitas IRRCS | Not yet recruiting | Rozzano | MI | 20089 | Italy |
|
| Azienda Ospedaliero - Universitaria di Modena | Active, not recruiting | Modena | MO | 41125 | Italy |
| Istituto Oncologico Veneto IRCCS | Recruiting | Padova | PD | 35128 | Italy |
|
| Azienda Ospedaliera di Perugia | Active, not recruiting | Perugia | PG | 06129 | Italy |
| Centro di Riferimento Oncologico IRCCS di Aviano | Not yet recruiting | Aviano | PN | 33081 | Italy |
|
| Azienda Ospedaliera - Universitaria di Parma | Recruiting | Parma | PR | 43126 | Italy |
|
| Fondazione IRCCS Policlinico S. Matteo | Not yet recruiting | Pavia | PV | 27100 | Italy |
|
| Azienda Ospedaliero - Universitaria di Reggio Emilia | Active, not recruiting | Reggio Emilia | RE | 42122 | Italy |
| Istituto Nazionale dei Tumori Regina Elena IRCCS - IFO | Not yet recruiting | Roma | RM | 00144 | Italy |
|
| Azienda Ospedaliera San Camillo Forlanini | Active, not recruiting | Roma | RM | 00152 | Italy |
| AOU San Luigi Orbassano | Not yet recruiting | Orbassano | TO | 10043 | Italy |
|
| Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) | Not yet recruiting | Udine | UD | 33100 | Italy |
|
| Azienda Ospedaliera Universitaria Integrata Verona | Not yet recruiting | Verona | VR | 37126 | Italy |
|
| Jan 14, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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