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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02214134
Recruitment Status : Completed
First Posted : August 12, 2014
Last Update Posted : July 8, 2022
Sponsor:
Collaborator:
ETOP IBCSG Partners Foundation
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

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.

Condition or disease Intervention/treatment
Any Stage of Lung Cancer (Any Histotype) Any Stage of Malignant Pleural Mesothelioma Any Stage of Any Thymic Malignancy Genetic: Tumour markers testing

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Study Type : Observational [Patient Registry]
Actual Enrollment : 539 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: SPECTAlung: Screening Patients With Thoracic Tumors for Efficient Clinical Trial Access
Actual Study Start Date : May 22, 2015
Actual Primary Completion Date : October 22, 2020
Actual Study Completion Date : May 12, 2021

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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 ]

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

Biospecimen Retention:   Samples With DNA
FFPE blocks of tumour tissue Blood samples Pleural effusion samples


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with pathologically confirmed lung cancer, MPM, thymoma or thymic carcinoma at any stage.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02214134


Locations
Show Show 18 study locations
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
ETOP IBCSG Partners Foundation
Investigators
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Study Chair: Benjamin Besse, MD, PhD Gustave Roussy, Cancer Campus, Grand Paris
Additional Information:

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Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT02214134    
Other Study ID Numbers: EORTC-1335-LCG-PBG
First Posted: August 12, 2014    Key Record Dates
Last Update Posted: July 8, 2022
Last Verified: July 2022
Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
Lung cancer
Malignant pleural mesothelioma
Thymic malignancy
Biomarkers
Screening
Additional relevant MeSH terms:
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Neoplasms
Mesothelioma
Mesothelioma, Malignant
Thoracic Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial
Pleural Neoplasms