Any Stage of Any Thymic Malignancy Clinical Trial
— SPECTAlungOfficial title:
SPECTAlung: Screening Patients With Thoracic Tumors for Efficient Clinical Trial Access
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.
| Status | Completed |
| Enrollment | 539 |
| Est. completion date | May 12, 2021 |
| Est. primary completion date | October 22, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Hopitaux Universitaires Bordet-Erasme - Institut Jules Bordet | Brussels | |
| Belgium | Universitair Ziekenhuis Antwerpen | Edegem | |
| Belgium | U.Z. Leuven - Campus Gasthuisberg | Leuven | |
| France | CHU de Lyon - Hopital Louis Pradel | Lyon | |
| France | Assistance Publique - Hopitaux de Marseille - Hopital Nord | Marseille | |
| France | CHU Toulouse - Hopital Larrey | Toulouse | |
| France | Gustave Roussy Cancer Campus | Villejuif | |
| Ireland | St. James's Hospital | Dublin | |
| Italy | Ospedale S. Luigi Gonzaga - Universita Di Torino | Torino | |
| Poland | Medical University Of Gdansk | Gdansk | |
| Slovenia | University Clinic Golnik | Golnik | |
| Spain | Hospital General Vall D'Hebron | Barcelona | |
| Spain | Hospital Universitario 12 De Octubre | Madrid | |
| Switzerland | Centre Hospitalier Universitaire Vaudois - Lausanne | Lausanne | |
| Switzerland | Centre Hospitalier Universitaire Vaudois - Lausanne | Lausanne | |
| United Kingdom | Royal Marsden Hospital - Kingston Hospital | Kingston upon Thames | |
| United Kingdom | Royal Marsden Hospital - Chelsea, London | London | |
| United Kingdom | Royal Marsden Hospital - Sutton, Surrey | Sutton |
| Lead Sponsor | Collaborator |
|---|---|
| European Organisation for Research and Treatment of Cancer - EORTC | European Thoracic Oncology Platform |
Belgium, France, Ireland, Italy, Poland, Slovenia, Spain, Switzerland, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of patients with thoracic malignancy (lung cancer, MPM and thymic malignancies) screened and efficiently allocated to biomarker-driven clinical trials. | 5 years | ||
| Secondary | Number of patients for whom the description of the biomarkers and correlation to clinical/pathological characteristics can be performed. | 5 years | ||
| Secondary | Number of exploratory/future research projects developped | 5 years |