SPECTAlung: Screening Patients With Thoracic Tumors for Efficient Clinical Trial Access
- Conditions
- Any Stage of Any Thymic MalignancyAny Stage of Lung Cancer (Any Histotype)Any Stage of Malignant Pleural Mesothelioma
- Interventions
- Genetic: Tumour markers testing
- Registration Number
- NCT02214134
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 539
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Malignant pleural mesothelioma Tumour markers testing Patients with diagnosis of malignant pleural mesothelioma at any stage Lung cancer Tumour markers testing Patients with diagnosis of lung cancer at any stage Thymic malignancy Tumour markers testing Patients with diagnosis of thymic malignancy at any stage
- Primary Outcome Measures
Name Time Method 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
Name Time Method Number of exploratory/future research projects developped 5 years Number of patients for whom the description of the biomarkers and correlation to clinical/pathological characteristics can be performed. 5 years
Trial Locations
- Locations (17)
CHU de Lyon - Hopital Louis Pradel
🇫🇷Lyon, France
U.Z. Leuven - Campus Gasthuisberg
🇧🇪Leuven, Belgium
Ospedale S. Luigi Gonzaga - Universita Di Torino
🇮🇹Torino, Italy
Medical University Of Gdansk
🇵🇱Gdansk, Poland
Hopitaux Universitaires Bordet-Erasme - Institut Jules Bordet
🇧🇪Brussels, Belgium
CHU Toulouse - Hopital Larrey
🇫🇷Toulouse, France
Universitair Ziekenhuis Antwerpen
🇧🇪Edegem, Belgium
Assistance Publique - Hopitaux de Marseille - Hopital Nord
🇫🇷Marseille, France
Gustave Roussy Cancer Campus
🇫🇷Villejuif, France
St. James's Hospital
🇮🇪Dublin, Ireland
Hospital General Vall D'Hebron
🇪🇸Barcelona, Spain
Royal Marsden Hospital - Chelsea, London
🇬🇧London, United Kingdom
University Clinic Golnik
🇸🇮Golnik, Slovenia
Royal Marsden Hospital - Kingston Hospital
🇬🇧Kingston upon Thames, United Kingdom
Hospital Universitario 12 De Octubre
🇪🇸Madrid, Spain
Centre Hospitalier Universitaire Vaudois - Lausanne
🇨🇭Lausanne, Switzerland
Royal Marsden Hospital - Sutton, Surrey
🇬🇧Sutton, United Kingdom