SPECTAlung: Screening Patients With Thoracic Tumors for Efficient Clinical Trial Access
Conditions
Any Stage of Lung Cancer (Any Histotype) - Any Stage of Malignant Pleural Mesothelioma - Any Stage of Any Thymic Malignancy
Conditions: official terms
Mesothelioma - Thoracic Neoplasms
Conditions: Keywords
Lung cancer, Malignant pleural mesothelioma, Thymic malignancy, Biomarkers, Screening
Study Type
Observational [Patient Registry]
Study Phase
N/A
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Intervention
Name: Tumour markers testing
Type: Genetic
Overall Status
Not yet recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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.
Location
Start Date
January 2015
Completion Date
January 2019
Sponsors
European Organisation for Research and Treatment of Cancer - EORTC
Source
European Organisation for Research and Treatment of Cancer - EORTC
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page