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

E

European Organisation for Research and Treatment of Cancer (EORTC)

Status

Completed

Conditions

Any Stage of Any Thymic Malignancy
Any Stage of Malignant Pleural Mesothelioma
Any Stage of Lung Cancer (Any Histotype)

Treatments

Genetic: Tumour markers testing

Study type

Observational

Funder types

NETWORK

Identifiers

NCT02214134
EORTC-1335-LCG-PBG

Details and patient eligibility

About

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.

Enrollment

539 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

539 participants in 3 patient groups

Lung cancer
Description:
Patients with diagnosis of lung cancer at any stage
Treatment:
Genetic: Tumour markers testing
Malignant pleural mesothelioma
Description:
Patients with diagnosis of malignant pleural mesothelioma at any stage
Treatment:
Genetic: Tumour markers testing
Thymic malignancy
Description:
Patients with diagnosis of thymic malignancy at any stage
Treatment:
Genetic: Tumour markers testing

Trial contacts and locations

18

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Data sourced from clinicaltrials.gov

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