Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Trial record 2 of 8 for:    mesothelioma screening

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2016 by European Organisation for Research and Treatment of Cancer - EORTC
Sponsor:
Collaborator:
European Thoracic Oncology Platform
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT02214134
First received: August 7, 2014
Last updated: May 27, 2016
Last verified: May 2016
  Purpose
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.

Condition Intervention
Any Stage of Lung Cancer (Any Histotype)
Any Stage of Malignant Pleural Mesothelioma
Any Stage of Any Thymic Malignancy
Genetic: Tumour markers testing

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: SPECTAlung: Screening Patients With Thoracic Tumors for Efficient Clinical Trial Access

Resource links provided by NLM:


Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Number of exploratory/future research projects developped [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA
FFPE blocks of tumour tissue Blood samples Pleural effusion samples

Estimated Enrollment: 3500
Study Start Date: May 2015
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Lung cancer
Patients with diagnosis of lung cancer at any stage
Genetic: Tumour markers testing
Malignant pleural mesothelioma
Patients with diagnosis of malignant pleural mesothelioma at any stage
Genetic: Tumour markers testing
Thymic malignancy
Patients with diagnosis of thymic malignancy at any stage
Genetic: Tumour markers testing

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with pathologically confirmed lung cancer, MPM, thymoma or thymic carcinoma at any stage.
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02214134

Contacts
Contact: Aline Gheeraert, MSc +32 2 774 15 06 aline.gheeraert@eortc.be

Locations
Belgium
Hopitaux Universitaires Bordet-Erasme - Institut Jules Bordet Recruiting
Brussels, Belgium, 1000
U.Z. Leuven - Campus Gasthuisberg Recruiting
Leuven, Belgium, 3000
France
CHU Toulouse - Hopital Larrey Recruiting
Toulouse, France, 31059
Gustave Roussy Cancer Campus Recruiting
Villejuif, France, 94805
Italy
Ospedale S. Luigi Gonzaga - Universita Di Torino Recruiting
Torino, Italy, 10043
Poland
Medical University Of Gdansk Recruiting
Gdansk, Poland, 80211
Slovenia
University Clinic Golnik Recruiting
Golnik, Slovenia, 4204
Spain
Hospital General Vall D'Hebron Recruiting
Barcelona, Spain, 08035
Hospital Universitario 12 De Octubre Recruiting
Madrid, Spain, ES 28041
Switzerland
Centre Hospitalier Universitaire Vaudois - Lausanne Not yet recruiting
Lausanne, Switzerland, CH 1011
Centre Hospitalier Universitaire Vaudois - Lausanne Recruiting
Lausanne, Switzerland, CH1011
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
European Thoracic Oncology Platform
Investigators
Study Chair: Benjamin Besse, MD, PhD Gustave Roussy, Cancer Campus, Grand Paris
  More Information

Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT02214134     History of Changes
Other Study ID Numbers: EORTC-1335-LCG-PBG 
Study First Received: August 7, 2014
Last Updated: May 27, 2016
Health Authority: Belgium: Ethics Committee
France: Committee for the Protection of Personnes
Slovenia: Ethics Committee
Poland: Ethics Committee
Spain: Ethics Committee
Ireland: Research Ethics Committee
Denmark: Ethics Committee
Italy: Ethics Committee
Switzerland: Ethikkommission
United Kingdom: Research Ethics Committee
Germany: Ethics Commission
Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
Lung cancer
Malignant pleural mesothelioma
Thymic malignancy
Biomarkers
Screening

Additional relevant MeSH terms:
Mesothelioma
Lung Neoplasms
Neoplasms
Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial

ClinicalTrials.gov processed this record on September 30, 2016