SPECTAlung: Screening Patients With Thoracic Tumors for Efficient Clinical Trial Access
Published: November 12, 2014
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:
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- 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.
