SPECTAlung: Screening Patients With Thoracic Tumors for Efficient Clinical Trial Access (SPECTAlung)
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Contacts and Locations
Study Locations
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Brussels, Belgium, 1000
- Hopitaux Universitaires Bordet-Erasme - Institut Jules Bordet
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Edegem, Belgium
- Universitair Ziekenhuis Antwerpen
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Leuven, Belgium, 3000
- U.Z. Leuven - Campus Gasthuisberg
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Lyon, France, 69394
- CHU de Lyon - Hopital Louis Pradel
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Marseille, France, 13015
- Assistance Publique - Hôpitaux de Marseille - Hôpital Nord
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Toulouse, France, 31059
- CHU Toulouse - Hopital Larrey
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Villejuif, France, 94805
- Gustave Roussy Cancer Campus
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Dublin, Ireland
- St. James's Hospital
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Torino, Italy, 10043
- Ospedale S. Luigi Gonzaga - Universita Di Torino
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Gdansk, Poland, 80211
- Medical University of Gdańsk
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Golnik, Slovenia, 4204
- University Clinic Golnik
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Barcelona, Spain, 08035
- Hospital General Vall D'Hebron
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Madrid, Spain, ES 28041
- Hospital Universitario 12 de Octubre
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Lausanne, Switzerland, CH 1011
- Centre Hospitalier Universitaire Vaudois - Lausanne
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Lausanne, Switzerland, CH1011
- Centre Hospitalier Universitaire Vaudois - Lausanne
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Kingston upon Thames, United Kingdom, KT2 7QB
- Royal Marsden Hospital - Kingston Hospital
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London, United Kingdom, SW3 6JJ
- Royal Marsden Hospital - Chelsea, London
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Sutton, United Kingdom, SM2 5PT
- Royal Marsden Hospital - Sutton, Surrey
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Number of groups / cohorts
Cohorts and Interventions
Group / CohortGroup / Cohort |
Intervention / TreatmentIntervention / Treatment |
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Lung cancer
Patients with diagnosis of lung cancer at any stage
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Malignant pleural mesothelioma
Patients with diagnosis of malignant pleural mesothelioma at any stage
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Thymic malignancy
Patients with diagnosis of thymic malignancy at any stage
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Time Frame |
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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
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5 years
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Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Number of patients for whom the description of the biomarkers and correlation to clinical/pathological characteristics can be performed.
Time Frame: 5 years
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5 years
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Number of exploratory/future research projects developped
Time Frame: 5 years
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5 years
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Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Study Chair: Benjamin Besse, MD, PhD, Gustave Roussy, Cancer Campus, Grand Paris
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Estimated)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- EORTC-1335-LCG-PBG
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.