Clinical trial NCT02834884: SPECTA: Screening Cancer Patients for Efficient Clinical Trial Access
Official title: SPECTA: Screening Cancer Patients for Efficient Clinical Trial Access
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: All Tumor Types
Keywords: rare cancer
biomarker
molecular screening
cancer
biobanking
Lead sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Sponsor class: NETWORK
First posted: 2016-07-15
Enrollment: 4975
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with pathologically confirmed selected tumor types.

Brief summary: SPECTA is a quality assured platform for collecting clinicopathologically annotated biological material, imaging data, operative images, environmental assessment, questionnaires as well as patient-reported outcomes from cancer patients to support biospecimen-based translational research and clinical cancer research, including biomarker discovery to improve the understanding of tumor biology and cancer patients care.

Detailed description: Patients are recruited in the platform for the research purpose of 4 downstream projects. For more information, please have a look at the "Groups and cohorts" section.

Eligibility criteria: * Patients with pathologically confirmed selected tumor types (at site or centrally);
* Mandatory availability of adequate human biological material (HBM);
* Centrally performed confirmation of HBM adequacy in terms of quality and quantity for SPECTA downstream project requirements;
* Age ≥ 12 years;
* Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule;
* Written informed consent according to applicable legal and ethical requirements;

Primary outcomes:
measure: To establish a quality assured platform to improve the understanding of tumor biology and cancer patients care
timeFrame: 5 years
Secondary outcomes:
measure: To perform biospecimen and data based high quality research aiming to better understand the biology of cancer, and/or how it is currently managed and/or how to better diagnose and treat it in the future;
timeFrame: 5 years
measure: To investigate the molecular pathways related to the development of specific tumors from a biological point of view;
timeFrame: 5 years
measure: To investigate the effect of cancer treatment on the tumor, microenvironment and patients globally;
timeFrame: 5 years
measure: To collect large series of homogeneous clinical data to analyse the disease course and treatment performed;
timeFrame: 5 years
measure: To investigate the prevalence and validate the prognostic or predictive value of novel biomarkers in cancers;
timeFrame: 5 years
measure: To perform biospecimen and data based high quality research aiming to facilitate the discovery of new test for tumor biomarkers or facilitate the establishment of validated tests for tumor biomarkers;
timeFrame: 5 years
measure: To identify patients with molecular alterations in their tumor that can be matched to biomarker-driven clinical trials, to facilitate enrollment of cancer patients in biomarker-driven clinical trials.
timeFrame: 5 years
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University Vienna - General Hospital AKH
city: Aalst
country: Belgium
facility: Onze Lieve Vrouw Ziekenhuis
city: Antwerp
country: Belgium
facility: ZAS Middelheim
city: Brussels
country: Belgium
facility: Hopitaux Universitaires - Institut Jules Bordet
city: Brussels
country: Belgium
facility: Universitair Ziekenhuis Brussel
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Haine-Saint-Paul
country: Belgium
facility: Pole Hospitalier Jolimont - Hopital Jolimont
city: Leuven
country: Belgium
facility: U.Z. Leuven - Campus Gasthuisberg
city: Liège
country: Belgium
facility: C.H.U. Sart-Tilman
city: Liège
country: Belgium
facility: Centre Hospitalier Regional De La Citadelle
city: Namur
country: Belgium
facility: CHU Site Sainte-Elisabeth-UCL Namur
city: Turnhout
country: Belgium
facility: AZ Turnhout - Campus Sint Elisabeth
city: Yvoir
country: Belgium
facility: CHU Mont Godinne - UCL Namur
city: Zagreb
country: Croatia
facility: University Hospital Centre Zagreb
city: Stróvolos
country: Cyprus
facility: Bank Of Cyprus Oncology Centre
city: Prague
country: Czechia
facility: University Hospital Motol
city: Tallinn
country: Estonia
facility: North Estonia Medical Centre - Mustamäe unit
city: Avignon
country: France
facility: Centre Hospitalier Avignon
city: Besancon
country: France
facility: CHRU de Besancon - Hopital Jean Minjoz
city: Beuvry
country: France
facility: Centre de Radiotherapie Pierre Curie
city: Bordeaux
country: France
facility: CHU de Bordeaux - Groupe Hospitalier Saint-Andre - Hopital Saint-Andre
city: Bordeaux
country: France
facility: Institut Bergonie
city: Boulogne-sur-Mer
country: France
facility: Centre Hospitalier - Boulogne Sur Mer
city: Bron
country: France
facility: CHU de Lyon - Hopital Louis Pradel
city: Bron
country: France
facility: CHU Lyon - Hopital neurologique Pierre Wertheimer
city: Caen
country: France
facility: Centre Francois Baclesse
city: Creteil
country: France
facility: Centre Hopitalier Intercommunal De Creteil
city: Dijon
country: France
facility: Centre Georges-Francois-Leclerc
city: Grenoble
country: France
facility: CHU de Grenoble - La Tronche - Hôpital A. Michallon
city: La Roche Sur Yon
country: France
facility: Centre Hospitalier Departemental Vendee
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lille
country: France
facility: CHRU de Lille
city: Lyon
country: France
facility: CHU de Lyon - Hopital Edouard Herriot
city: Lyon
country: France
facility: Centre Léon Berard
city: Lyon
country: France
facility: CHU de Lyon - Hopital Lyon Sud
city: Marseille
country: France
facility: Assistance Publique - Hopitaux de Marseille - Hopital Nord
city: Metz-Tessy
country: France
facility: Centre Hospitalier D'Annecy Genevois
city: Montpellier
country: France
facility: CHU Montpellier-Hopital Arnaud De Villeneuve
city: Montpellier
country: France
facility: Institut du Cancer de Montpellier
city: Morlaix
country: France
facility: Centre Hospitalier Des Pays De Morlaix
city: Nancy
country: France
facility: Centre d'Oncologie de Gentilly
city: Nice
country: France
facility: CHU de Nice - Hopital De L'Archet
city: Paris
country: France
facility: Assitance Publique - Hopitaux de Paris - Hopital Saint-Louis
city: Paris
country: France
facility: Assistance Publique - Hopitaux de Paris - Hopital Saint Antoine
city: Paris
country: France
facility: Assistance Publique - Hopitaux de Paris - La Pitie Salpetriere
city: Paris
country: France
facility: Institut Curie- Hopital de Paris
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint-Joseph - Hopital Saint Joseph
city: Rennes
country: France
facility: Centre Eugene Marquis
city: Saint Nazaire
country: France
facility: Clinique Mutualiste de l'Estuaire - Centre d'oncologie
city: Saint-Herblain
country: France
facility: Institut de Cancerologie de l'Ouest (ICO) - Centre Rene Gauducheau
city: Saint-Priest-en-Jarez
country: France
facility: Institut de Cancerologie de la Loire Lucien Neuwirth
city: Strasbourg
country: France
facility: Institut de Cancerologie Strasbourg Europe (formar Paul Strauss)
city: Toulouse
country: France
facility: CHU Toulouse - Hopital Larrey
city: Villejuif
country: France
facility: Gustave Roussy
city: Berlin
country: Germany
facility: Charite - Universitaetsmedizin Berlin - Campus Virchow-Klinikum
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus
city: Greifswald
country: Germany
facility: Universitaetsklinikum Greifswald der Ernst Morizt Arndt Univ. Greifswald AoR
city: Jena
country: Germany
facility: Universitaetsklinikum Jena
city: Leer
country: Germany
facility: Onkologie UnterEms, Leer-Papenburg-Emden
city: Athens
country: Greece
facility: NIMTS - Veterans Administration Hospital
city: Athens
country: Greece
facility: Athens University - Attikon University General Hospital
city: Athens
country: Greece
facility: Hygeia Hospital
city: Ioánnina
country: Greece
facility: Ioannina University Hospital
city: Alessandria
country: Italy
facility: Ospedale Civile Santi Antonio e Biagio e Cesare Arrigo
city: Bologna
country: Italy
facility: Alma Mater Studiorium Universita di Bologna - Loc. Ospedala Sant'Orsolo
city: Brescia
country: Italy
facility: Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
city: Cremona
country: Italy
facility: Azienda Istituti Ospitalieri di Cremona
city: Genova
country: Italy
facility: IRCCS Azienda Ospedaliera Universitaria San Martino "IST" Istituto Nazionale per la Ricerca sul Cancro
city: Legnago
country: Italy
facility: Azienda Unita Locale Socio-Sanitaria N. 9-Mater Salutis Hospital
city: Milano
country: Italy
facility: IRCCS - Istituto Neurologico Carlo Besta
city: Napoli
country: Italy
facility: Azienda Sanitaria Locale Napoli 1 Centro
city: Orbassano
country: Italy
facility: Universita Di Torino - Ospedale S. Luigi Gonzaga
city: Padova
country: Italy
facility: IRCCS - Istituto Oncologico Veneto
city: Pavia
country: Italy
facility: Istituti Clinici Scientifici Maugeri
city: Roma
country: Italy
facility: Regina Elena National Cancer Center
city: Torino
country: Italy
facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino - Ospedale Molinette
city: Torino
country: Italy
facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino - Ospedale San Giovanni - Dipartimento Neuroscienze
city: Torino
country: Italy
facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino - Ospedale Sant'Anna
city: Vilnius
country: Lithuania
facility: Lithuanian Oncology Center-Nat. Cancer Inst
city: Amsterdam
country: Netherlands
facility: The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC - Locatie AMC
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Maastricht
country: Netherlands
facility: Academisch Ziekenhuis Maastricht
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Center Nijmegen
city: Gdansk
country: Poland
facility: Medical University Of Gdansk
city: Gliwice
country: Poland
facility: Maria S. Curie Memorial Institute-Gliwice Branch
city: Poznan
country: Poland
facility: The Great Poland Cancer Centre
city: Warsaw
country: Poland
facility: Maria Sklodowska-Curie Memorial Cancer Centre
city: Coimbra
country: Portugal
facility: Instituto Portugues De Oncologia - Centro De Coimbra
city: Lisboa
country: Portugal
facility: Instituto Portugues de Oncologia de Lisboa Francisco Gentil - EPE
city: Lisboa
country: Portugal
facility: Hospital CUF Tejo
city: Lisboa
country: Portugal
facility: Centro Hospitalar de Lisboa Ocidental- San Francisco Xavier Hospital
city: Lisboa
country: Portugal
facility: Hospital CUF Descobertas
city: Porto
country: Portugal
facility: Centro Hospitalar do Porto- Hospital de Santo Antonio
city: Porto
country: Portugal
facility: Instituto Portugues de Oncologia do Porto
city: Vila Nova De Gaia
country: Portugal
facility: Unidade Local de Saúde Gaia e Espinho
city: Cluj
country: Romania
facility: Medisprof Cancer Center srl
state: Cluj Napoca
city: Belgrade
country: Serbia
facility: University Clinic Centre Serbia - Pulmonology clinic
city: Belgrade
country: Serbia
facility: University Clinical Center of Serbia - Clinic for ENT and MFH
city: Golnik
country: Slovenia
facility: University Clinic Golnik
city: Maribor
country: Slovenia
facility: University Medical Center Maribor
city: L' Hospitalet De Llobregat
country: Spain
facility: ICO L'Hospitalet - Hospital Duran i Reynals (Institut Catala D'Oncologia)
state: Barcelona
city: Barcelona
country: Spain
facility: Vall d'Hebron Institut d'Oncologia
city: Barcelona
country: Spain
facility: Hospital Clinic Universitari de Barcelona
city: Barcelona
country: Spain
facility: Hospital De La Santa Creu I Sant Pau
city: Elche
country: Spain
facility: Hospital General Universitario De Elche
city: Girona
country: Spain
facility: ICO Girona - Hospital Doctor Josep Trueta (Institut Catala D'Oncologia)
city: L'Hospitalet De Llobregat
country: Spain
facility: ICO L'Hospitalet- Hospital Universitari de Bellvitge
city: Madrid
country: Spain
facility: Hospital Infantil Universitario Nino Jesus
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario QuironSalud
city: Malaga
country: Spain
facility: Hospital Universitario Virgen De La Victoria
city: Valencia
country: Spain
facility: Hospital Clinico Universitario De Valencia
city: Valladolid
country: Spain
facility: Hospital Clinico Universitario De Valladolid
city: Valladolid
country: Spain
facility: Hospital Clinico Universitaro De Valladolid
city: Aarau
country: Switzerland
facility: Hirslanden Klinik-Tumor Zentrum Aarau
city: Saint Gallen
country: Switzerland
facility: Kantonsspital St Gallen
city: Zurich
country: Switzerland
facility: UniversitaetsSpital Zurich
city: Bodelwyddan
country: United Kingdom
facility: Betsi Cadwaladr University Health Board - Glan Clwyd District General Hospital
state: Denbighshire
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Foundation Trust (UHB) - UHB-Queen Elisabeth Medical Centre
city: Birmingham
country: United Kingdom
facility: Royal Orthopaedics Hospital, NHS Trust
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospital NHS - Addenbrookes Hospital
city: Cardiff
country: United Kingdom
facility: Velindre NHS Trust - Velindre Cancer Centre
city: Coventry
country: United Kingdom
facility: University Hospitals Coventry and Warwickshire NHS Trust - University Hospital
city: Edinburgh
country: United Kingdom
facility: NHS Lothian - Western General Hospital
city: Glasgow
country: United Kingdom
facility: NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital
city: Hereford
country: United Kingdom
facility: Hereford County Hospital
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust - St. James's University Hospital
city: London
country: United Kingdom
facility: Royal Free Hospital
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
Study officials:
affiliation: European Organisation for Research and Treatment of Cancer - EORTC
name: Benjamin Besse, Pr.
role: STUDY_CHAIR
References: