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

July 7, 2022 updated by: European Organisation for Research and Treatment of Cancer - EORTC
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

539

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1000
        • Hôpitaux Universitaires Bordet-Erasme - Institut Jules Bordet
      • Edegem, Belgium
        • Universitair Ziekenhuis Antwerpen
      • Leuven, Belgium, 3000
        • U.Z. Leuven - Campus Gasthuisberg
  • France
      • Lyon, France, 69394
        • CHU de Lyon - Hopital Louis Pradel
      • Marseille, France, 13015
        • Assistance Publique - Hopitaux de Marseille - Hopital Nord
      • Toulouse, France, 31059
        • CHU Toulouse - Hopital Larrey
      • Villejuif, France, 94805
        • Gustave Roussy Cancer Campus
  • Ireland
      • Dublin, Ireland
        • St. James's Hospital
  • Italy
      • Torino, Italy, 10043
        • Ospedale S. Luigi Gonzaga - Universita Di Torino
  • Poland
      • Gdansk, Poland, 80211
        • Medical University of Gdansk
  • Slovenia
      • Golnik, Slovenia, 4204
        • University Clinic Golnik
  • Spain
      • Barcelona, Spain, 08035
        • Hospital General Vall D'Hebron
      • Madrid, Spain, ES 28041
        • Hospital Universitario 12 De Octubre
  • Switzerland
      • Lausanne, Switzerland, CH 1011
        • Centre Hospitalier Universitaire Vaudois - Lausanne
      • Lausanne, Switzerland, CH1011
        • Centre Hospitalier Universitaire Vaudois - Lausanne
  • United Kingdom
      • Kingston upon Thames, United Kingdom, KT2 7QB
        • Royal Marsden Hospital - Kingston Hospital
      • London, United Kingdom, SW3 6JJ
        • Royal Marsden Hospital - Chelsea, London
      • Sutton, United Kingdom, SM2 5PT
        • Royal Marsden Hospital - Sutton, Surrey

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with pathologically confirmed lung cancer, MPM, thymoma or thymic carcinoma at any stage.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of patients for whom the description of the biomarkers and correlation to clinical/pathological characteristics can be performed.
Time Frame: 5 years
5 years
Number of exploratory/future research projects developped
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Collaborators

ETOP IBCSG Partners Foundation

Investigators

  • Study Chair: Benjamin Besse, MD, PhD, Gustave Roussy, Cancer Campus, Grand Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 22, 2015

Primary Completion (Actual)

October 22, 2020

Study Completion (Actual)

May 12, 2021

Study Registration Dates

First Submitted

August 7, 2014

First Submitted That Met QC Criteria

August 8, 2014

First Posted (Estimate)

August 12, 2014

Study Record Updates

Last Update Posted (Actual)

July 8, 2022

Last Update Submitted That Met QC Criteria

July 7, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.

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