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Registry and follow up of indeterminate nodules using the EarlyCDT

Registry of patients with indeterminate pulmonary nodules who have been tested with the EarlyCDT-Lung test for medical professionals who are members of the Spanish Society of Pneumology and Thoracic Surgery (SEPAR)

Computed tomography (CT) is routinely performed to study various  respiratory ailments, including lung cancer. The routine use of CT is leading to the detection of an increasing number of pulmonary nodules. Even in high-risk patients, most of these nodules are benign, but their detection alters patients' quality of life  since it can lead to invasive tests or uncertainty during radiological follow-up.

 

Current recommendations regarding the management of nodules that measure between 6 and 15 mm in diameter vary between scientific societies. Diagnostic options include CT follow-up, characterization of the nodule by PET CT, or biopsy, depending on the nodule's characteristics  (size, spiculation, location) and the patient's risk factors (age, smoking, family history). The PET CT scan, essential in the staging of patients with lung cancer or the characterization of nodules larger than 15 mm in diameter, lacks sufficient sensitivity and specificity for smaller nodules. Faced with an expectant attitude, the speed of duplication of the nodule in 3 to 6 months is usually the only criterion used to recommend a biopsy performance.

 

In this context, the use of biomarkers (circulating DNA, microRNA or autoantibodies) associated with the presence of lung cancer is being investigated. The EarlyCDT-Lung test has been validated for the characterization of indeterminate pulmonary nodules. It is a blood test that identifies antibodies against a panel of seven tumour antigens related to this neoplasm. The test's accuracy is 92%, with an average sensitivity and specificity of 41% and 93%, respectively, for lung cancer.

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The REFINE registry's principal investigator is Dr Luis Seijo, co-director of the Pneumology Service at the University of Navarra Clinic (CUN). The Medical Research Ethics Committee (CEIM) of the CUN approved the project in June 2020 and integrated it into the Comprehensive Research Plan or PII of Oncology of the Spanish Society of Pulmonology and Thoracic Surgery (SEPAR). 

The project records the results obtained in routine clinical practice using the blood test combined with CT for the early detection of lung cancer and the management of indeterminate pulmonary nodules. To guarantee the REFINE project's independence, transparency, and scientific quality, a scientific committee composed of pulmonologists and thoracic surgeons have been formed.

 

The members of this committee are the following:

 

PNEUMOLOGY

 

  • Dr Luis M. Seijo Maceiras (PI), Clínica Univ. de Navarra (Madrid)

  • Dr Pedro J. Marcos Rodriguez, Complejo Hospital. Universitario de Coruña (A Coruña)

  • Dr German Peces Barba, Fundación Jiménez Díaz (Madrid)

  • Dr Rocio Gallego Dominguez, Hospital San Pedro de Alcántara (Cáceres)

  • Dr Antonio Pereira Vega, Hospital Juan Ramón Jiménez (Huelva)

  • Dr Emilio Ansotegui, Hospital Universitario y Politécnico la Fe (Valencia)

  • Dr Javier Pérez Pallarés, Pulmonologist at Hospital Santa Lucía (Cartagena)

 

THORACIC SURGERY

 

  • Dr Juan Carlos Trujillo, Hospital Sant Pau (Barcelona)

  • Dr Eduardo Rivo, Complejo Hospital. Universitario de Santiago (Santiago de Compostela)

  • Dr Javier García Tirado, Hospital Miguel Servet (Zaragoza)

Sullivan FM et al
Tanner NT et al
Healey et al
Maisson PP et al
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