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

Brief Title

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

Official Title

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.

Study Type

Observational [Patient Registry]

Primary Outcome

Number of patients with thoracic malignancy (lung cancer, MPM and thymic malignancies) screened and efficiently allocated to biomarker-driven clinical trials.

Secondary Outcome

 Number of patients for whom the description of the biomarkers and correlation to clinical/pathological characteristics can be performed.

Condition

Any Stage of Lung Cancer (Any Histotype)

Intervention

Tumour markers testing

Study Arms / Comparison Groups

 Lung cancer

Description:  Patients with diagnosis of lung cancer at any stage

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Genetic

Estimated Enrollment

Start Date

May 2015

Completion Date

January 2019

Primary Completion Date

January 2019

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.

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Benjamin Besse, MD, PhD, +32 2 774 10 43, [email protected]

Location Countries

Belgium

Location Countries

Belgium

Administrative Informations

NCT ID

NCT02214134

Organization ID

EORTC-1335-LCG-PBG

Responsible Party

Sponsor

Study Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Collaborators

 European Thoracic Oncology Platform

Study Sponsor

Benjamin Besse, MD, PhD, Study Chair, Gustave Roussy, Cancer Campus, Grand Paris

Verification Date

January 2017