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

Primary Outcome Measure:

• Number of patients with thoracic malignancy (lung cancer, MPM and thymic malignancies) screened and efficiently allocated to biomarker-driven clinical trials. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

• Number of patients for whom the description of the biomarkers and correlation to clinical/pathological characteristics can be performed. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
• Number of exploratory/future research projects developped [ Time Frame: 5 years ] [ Designated as safety issue: No ]

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.