SPECTAlung: Screening Patients With Thoracic Tumors for Efficient Clinical Trial Access

Study Overview
=================
Brief Summary
-----------------
SPECTAlung is a program aiming at screening patients with thoracic tumors to identify the molecular characteristics of their disease. The thoracic tumors include lung cancer, malignant pleural mesothelioma, thymoma or thymic carcinoma at any stage. Once the molecular characteristics are identified, there might be the possibility to offer these patients access to targeted clinical trials.

Official Title
-----------------
SPECTAlung: Screening Patients With Thoracic Tumors for Efficient Clinical Trial Access

Conditions
-----------------
Any Stage of Lung Cancer (Any Histotype), Any Stage of Malignant Pleural Mesothelioma, Any Stage of Any Thymic Malignancy

Intervention / Treatment
-----------------
* Genetic: Tumour markers testing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pathologically confirmed lung cancer, MPM, thymoma or thymic carcinoma at any stage; Mandatory availability of adequate Human Biological Material (HBM): FFPE tissue sample from the primary tumor, recurrent tumor, metastasis, obtained at the time of primary surgery or biopsy; minimal amount requested is detailed in the HBM guidelines; inclusion of samples taken at any recurrence diagnosed during follow-up is strongly encouraged but optional; Centrally performed confirmation of tumor tissue adequacy in terms of quality/ quantity for central screening; Age ≥ 18 years; At least three months life-expectancy; Written informed consent according to ICH/GCP and national/local regulations. Exclusion Criteria: Any active malignancy, except pT1-2 prostatic cancer Gleason score < 6, non melanomatous skin cancer or carcinoma in situ of the cervix, in the 5 years before study entry; Active hepatitis B/C or HIV; Any secondary malignancy; Any severe organ dysfunction or other comorbidities that may prevent the inclusion into clinical trials.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lung cancer<br>Patients with diagnosis of lung cancer at any stage | Genetic: Tumour markers testing<br> <br> |
| Malignant pleural mesothelioma<br>Patients with diagnosis of malignant pleural mesothelioma at any stage | Genetic: Tumour markers testing<br> <br> |
| Thymic malignancy<br>Patients with diagnosis of thymic malignancy at any stage | Genetic: Tumour markers testing<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with thoracic malignancy (lung cancer, MPM and thymic malignancies) screened and efficiently allocated to biomarker-driven clinical trials. |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients for whom the description of the biomarkers and correlation to clinical/pathological characteristics can be performed. |  | 5 years | 
| Number of exploratory/future research projects developped |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lung cancer, Malignant pleural mesothelioma, Thymic malignancy, Biomarkers, Screening