Quantification of microRNAs in Diagnosis of Pulmonary Nodules

NCT03293433 | Completed

• 1 other identifier: RC31/15/7818
• Study Type: observational
• Target: 103
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• 34 micro RNA extraction as assessed by quantification of micro RNA with Real-Time Quantitative Reverse Transcription polymerase chain reaction

  Through the completion of study (18 months)

Secondary Outcomes (2)

• Measure the inter-observer reproducibility as assessed by quantification of micro RNA in total blood with Real-Time Quantitative Reverse Transcription polymerase chain reaction

  Through the completion of study (18 months)

• Measure the inter-laboratory reproducibility as assessed by rate of micro RNA in total blood with Real-Time Quantitative Reverse Transcription polymerase chain reaction

  Through the completion of study (18 months)

Study Arms (1)

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.

Other: Blood punction

Interventions

Blood punction 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.

Patient with lung cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (2)

University Hospital of la Réunion

La Réunion, 97400, France

Location

University Hospital of Toulouse

Toulouse, 31059, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Total blood punction with micro RNA exctraction

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• GUIBERT NICOLAS, MD

  University Hospital of Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2016
• First Posted: September 26, 2017
• Study Start: November 1, 2015
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2019
• Last Updated: July 16, 2019

Record last verified: 2019-07

Locations

FR (2)