Any Stage of Any Thymic Malignancy, Any Stage of Lung Cancer (Any Histotype), Any Stage of Malignant Pleural Mesothelioma
Conditions
Keywords
Lung cancer, Malignant pleural mesothelioma, Thymic malignancy, Biomarkers, Screening
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.
Interventions
GENETICTumour markers testing
Sponsors
ETOP IBCSG Partners Foundation
European Organisation for Research and Treatment of Cancer - EORTC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
Belgium, France, Ireland, Italy, Poland, Slovenia, Spain, Switzerland, United Kingdom
Outcome results
None listed