Clinical trial NCT02214134: SPECTAlung: Screening Patients With Thoracic Tumors for Efficient Clinical Trial Access
Official title: SPECTAlung: Screening Patients With Thoracic Tumors for Efficient Clinical Trial Access
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Any Stage of Lung Cancer (Any Histotype)
Any Stage of Malignant Pleural Mesothelioma
Any Stage of Any Thymic Malignancy
Keywords: Lung cancer
Malignant pleural mesothelioma
Thymic malignancy
Biomarkers
Screening
Lead sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Sponsor class: NETWORK
Collaborators: name: ETOP IBCSG Partners Foundation
First posted: 2014-08-12
Enrollment: 539
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with pathologically confirmed lung cancer, MPM, thymoma or thymic carcinoma at any stage.

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.


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.

Primary outcomes:
measure: Number of patients with thoracic malignancy (lung cancer, MPM and thymic malignancies) screened and efficiently allocated to biomarker-driven clinical trials.
timeFrame: 5 years
Secondary outcomes:
measure: Number of patients for whom the description of the biomarkers and correlation to clinical/pathological characteristics can be performed.
timeFrame: 5 years
measure: Number of exploratory/future research projects developped
timeFrame: 5 years
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Hopitaux Universitaires Bordet-Erasme - Institut Jules Bordet
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
city: Leuven
country: Belgium
facility: U.Z. Leuven - Campus Gasthuisberg
city: Lyon
country: France
facility: CHU de Lyon - Hopital Louis Pradel
city: Marseille
country: France
facility: Assistance Publique - Hopitaux de Marseille - Hopital Nord
city: Toulouse
country: France
facility: CHU Toulouse - Hopital Larrey
city: Villejuif
country: France
facility: Gustave Roussy Cancer Campus
city: Dublin
country: Ireland
facility: St. James's Hospital
city: Torino
country: Italy
facility: Ospedale S. Luigi Gonzaga - Universita Di Torino
city: Gdansk
country: Poland
facility: Medical University Of Gdansk
city: Golnik
country: Slovenia
facility: University Clinic Golnik
city: Barcelona
country: Spain
facility: Hospital General Vall D'Hebron
city: Madrid
country: Spain
facility: Hospital Universitario 12 De Octubre
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois - Lausanne
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois - Lausanne
city: Kingston upon Thames
country: United Kingdom
facility: Royal Marsden Hospital - Kingston Hospital
city: London
country: United Kingdom
facility: Royal Marsden Hospital - Chelsea, London
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital - Sutton, Surrey
Study officials:
affiliation: Gustave Roussy, Cancer Campus, Grand Paris
name: Benjamin Besse, MD, PhD
role: STUDY_CHAIR
References: