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

Completed

• Conditions: Any Stage of Any Thymic Malignancy; Any Stage of Lung Cancer (Any Histotype); Any Stage of Malignant Pleural Mesothelioma

• Registration Number: NCT02214134
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-08-07
• Study First Submitted QC: 2014-08-08
• Study First Posted: 2014-08-12
• Study Start: 2015-05-22
• Primary Completion: 2020-10-22
• Study Completion: 2021-05-12
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-13
• Last Update Posted: 2025-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 539

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patients with thoracic malignancy (lung cancer, MPM and thymic malignancies) screened and efficiently allocated to biomarker-driven clinical trials.	5 years

Secondary Outcome Measures

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

Trial Locations

Locations (17)

Hopitaux Universitaires Bordet-Erasme - Institut Jules Bordet; 🇧🇪 Brussels, Belgium

Universitair Ziekenhuis Antwerpen; 🇧🇪 Edegem, Belgium

U.Z. Leuven - Campus Gasthuisberg; 🇧🇪 Leuven, Belgium

CHU de Lyon - Hopital Louis Pradel; 🇫🇷 Lyon, France

Assistance Publique - Hopitaux de Marseille - Hopital Nord; 🇫🇷 Marseille, France

CHU Toulouse - Hopital Larrey; 🇫🇷 Toulouse, France

Gustave Roussy Cancer Campus; 🇫🇷 Villejuif, France

St. James's Hospital; 🇮🇪 Dublin, Ireland

Ospedale S. Luigi Gonzaga - Universita Di Torino; 🇮🇹 Torino, Italy

Medical University Of Gdansk; 🇵🇱 Gdansk, Poland

Scroll for more (7 remaining)