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SPECTAlung: Screening Patients With Thoracic Tumors for Efficient Clinical Trial Access

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.

Tracking Information
First Received DateAugust 7, 2014
Last Changed DateJanuary 17, 2017
Start DateMay 2015
Anticipated Primary Completion DateJanuary 2019
Primary Outcome Measures

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]

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]

Number of exploratory/future research projects developped [Time Frame: 5 years]

Descriptive Information
PhaseN/A
Study TypeObservational [Patient Registry]
Condition
  • Any Stage of Lung Cancer (Any Histotype)
  • Any Stage of Malignant Pleural Mesothelioma
  • Any Stage of Any Thymic Malignancy
Intervention
  • Genetic: Tumour markers testing
Study Arms / Comparison Groups0 / 3
Recruitment Information
Recruitment StatusRecruiting
Anticipated Enrollment3500
GenderAll
Ages18 Years - N/A
Accepts Healthy VolunteersNo
Contact Aleksandra Peric, PhD
Email: aleksandra.peric@eortc.be
Phone: +32 2 774 10 43
Eligibility 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.

Administrative Information
NCTIDNCT02214134
Responsible Party,
SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC
Verification DateJanuary 2017
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