Quantification of microRNAs in Diagnosis of Pulmonary Nodules

NCT ID: NCT03293433

Last Updated: 2019-07-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 103 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2019-05-31

Brief Summary

One of the main challenges of thoracic oncology lies in earlier diagnosis of lung cancer to improve survival rate, wich is about 15% at 5 years. This poor prognosis is often linked to late diagnosis. Efforts are being made worldwide to offer testing in patients at risk or earlier diagnosis of lung cancer in order to offer the patient curative treatments. Indeed, supported at the stage of nodule (less than 3 cm lesion), lung cancer is curable by surgery in 80% of patients. Nevertheless, there are many differential diagnoses and access to these lesions is often difficult and risky. In this context, the management of pulmonary nodules, which can be either benign lesions or beginners cancers, is a real challenge for pulmonologists and thoracic oncologists every day: it is important not to disregard a potentially operable nodule and avoiding offer patients invasive procedures for benign nodules. Indeed, many procedures (endoscopy, puncture under scanner, thoracotomy) are made to determine if suspicious nodules are benign or not. In the large National Lung Screening Trial, 28% of the procedures were associated with complications (including 11% classified severe and 16 deaths). It is therefore essential to develop non-invasive tools to refine treatment decisions.

Conditions

Pulmonary Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patient with lung cancer

Patient with pulmonary nodule showed in scanner (defined as a rounded picture higher than 5 mm and less than 30 mm in the lung parenchyma) presenting at one of the 3 participant services and meeting the inclusion criteria and exclusion. A blood punction will be performed in order to extract micro RNA.

Blood punction

Intervention Type: OTHER

1 blood punction during the normal pathway of care of the patient. This punction will be used to perform the extraction of micro RNA.

Interventions

Blood punction

1 blood punction during the normal pathway of care of the patient. This punction will be used to perform the extraction of micro RNA.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients with suspected abnormal chest X-ray image of malignancy defined by one solitary pulmonary nodule (NPS) NPS or 2 if operable, higher than 5 mm and less to 30 mm, without histological evidence.
• Affiliation to social security.
• Signature of informed consent.

Exclusion Criteria

• Nodule not accessible to curative local therapy (surgery, thermoablation, radiotherapy).
• Patients in whom resection for diagnostic purposes this emergency such as one of these characters can not be delayed (these patients are not likely to belong to the people that can take a dosage of clinical interest miRNAs because the characteristics radiographic their nodule only tell them a high probability of lung cancer)
• History of an unhealed cancer
• Patients benefiting from a system of legal protection

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GUIBERT NICOLAS, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Toulouse

Locations

University Hospital of la Réunion

La Réunion, , France

University Hospital of Toulouse

Toulouse, , France

Countries

France

Other Identifiers

RC31/15/7818

Identifier Type: -

Identifier Source: org_study_id