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Recruiting NCT02834884

SPECTA: Screening Cancer Patients for Efficient Clinical Trial Access

Observational All Tumor Types

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: RP-1828 IMMUcan, RP-1759 AYA/TYA, RP-1843 Arcagen, RP-1920 BioRadon.
Who it may be relevant to
Registry conditions: All Tumor Types. Basic parameters: from 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Austria, Belgium, Croatia, Cyprus, Czechia +15
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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 5 downstream projects. For more information, please have a look at the "Groups and cohorts" section.

Interventions

  • Genetic RP-1828 IMMUcan
    WES, lcWGS and RNAseq, multiplex IF and IMC
  • Genetic RP-1759 AYA/TYA
    WES, RNAseq and EPIC array
  • Genetic RP-1843 Arcagen
    NGS panel
  • Genetic RP-1920 BioRadon
    NGS panel
  • Genetic 2148 MRD
    ctDNA detection and WES

Primary outcome measures

  • To establish a quality assured platform to improve the understanding of tumor biology and cancer patients care [Time frame: 5 years]
Secondary outcome measures (7)
  • 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; [Time frame: 5 years]
  • To investigate the molecular pathways related to the development of specific tumors from a biological point of view; [Time frame: 5 years]
  • To investigate the effect of cancer treatment on the tumor, microenvironment and patients globally; [Time frame: 5 years]
  • To collect large series of homogeneous clinical data to analyse the disease course and treatment performed; [Time frame: 5 years]
  • To investigate the prevalence and validate the prognostic or predictive value of novel biomarkers in cancers; [Time frame: 5 years]
  • 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; [Time frame: 5 years]
  • 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. [Time frame: 5 years]

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;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 37 centers
  • Centre Hospitalier Avignon — Avignon
  • CHRU de Besancon - Hopital Jean Minjoz — Besançon
  • Centre de Radiotherapie Pierre Curie — Beuvry
  • CHU de Bordeaux - Groupe Hospitalier Saint-Andre - Hopital Saint-Andre — Bordeaux
  • Institut Bergonie — Bordeaux
  • Centre Hospitalier - Boulogne Sur Mer — Boulogne-sur-Mer
  • CHU de Lyon - Hopital Louis Pradel — Bron
  • CHU Lyon - Hopital neurologique Pierre Wertheimer — Bron
  • … and 29 more centers
Spain · 17 centers

Center list to be confirmed — check the primary protocol.

Italy · 16 centers
  • Ospedale Civile Santi Antonio e Biagio e Cesare Arrigo — Alessandria
  • Alma Mater Studiorium Universita di Bologna - Loc. Ospedala Sant'Orsolo — Bologna
  • Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia — Brescia
  • Azienda Istituti Ospitalieri di Cremona — Cremona
  • IRCCS Azienda Ospedaliera Universitaria San Martino "IST" Istituto Nazionale per la Ricerc — Genova
  • Azienda Unita Locale Socio-Sanitaria N. 9-Mater Salutis Hospital — Legnago
  • IRCCS - Fondazione Istituto Nazionale dei Tumori — Milan
  • IRCCS - Istituto Neurologico Carlo Besta — Milan
  • … and 8 more centers
Belgium · 13 centers
  • Onze Lieve Vrouw Ziekenhuis — Aalst
  • ZAS Middelheim — Antwerp
  • Hopitaux Universitaires - Institut Jules Bordet — Brussels
  • Universitair Ziekenhuis Brussel — Brussels
  • Cliniques Universitaires Saint-Luc — Brussels
  • Universitair Ziekenhuis Gent — Ghent
  • Pole Hospitalier Jolimont - Hopital Jolimont — Haine-Saint-Paul
  • U.Z. Leuven - Campus Gasthuisberg — Leuven
  • … and 5 more centers
United Kingdom · 13 centers

Center list to be confirmed — check the primary protocol.

Portugal · 8 centers

Center list to be confirmed — check the primary protocol.

Germany · 5 centers
  • Charite - Universitaetsmedizin Berlin - Campus Virchow-Klinikum — Berlin
  • Universitaetsklinikum Carl Gustav Carus — Dresden
  • Universitaetsklinikum Greifswald der Ernst Morizt Arndt Univ. Greifswald AoR — Greifswald
  • Universitaetsklinikum Jena — Jena
  • Onkologie UnterEms, Leer-Papenburg-Emden — Leer
Netherlands · 5 centers

Center list to be confirmed — check the primary protocol.

Greece · 4 centers
  • NIMTS - Veterans Administration Hospital — Athens
  • Athens University - Attikon University General Hospital — Athens
  • Hygeia Hospital — Athens
  • Ioannina University Hospital — Ioannina
Poland · 4 centers

Center list to be confirmed — check the primary protocol.

Switzerland · 3 centers

Center list to be confirmed — check the primary protocol.

Serbia · 2 centers

Center list to be confirmed — check the primary protocol.

Slovenia · 2 centers

Center list to be confirmed — check the primary protocol.

Austria · 1 center
  • Medical University Vienna - General Hospital AKH — Vienna
Croatia · 1 center
  • University Hospital Centre Zagreb — Zagreb
Cyprus · 1 center
  • Bank Of Cyprus Oncology Centre — Stróvolos
Czechia · 1 center
  • University Hospital Motol — Prague
Estonia · 1 center
  • North Estonia Medical Centre - Mustamäe unit — Tallinn
Lithuania · 1 center

Center list to be confirmed — check the primary protocol.

Romania · 1 center

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT02834884 · EORTC-1553

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗