Skip to main content
OpenTrials
Completed

NCT Number: NCT03293433

Quantification of microRNAs in Diagnosis of Pulmonary Nodules

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of la Réunion, La Réunion, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 34 micro RNA extraction as assessed by quantification of micro RNA with Real-Time Quantitative Reverse Transcription polymerase chain reaction

    Time frame: Through the completion of study (18 months)

Secondary outcomes

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

    Time frame: Through the completion of study (18 months)

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

    Time frame: Through the completion of study (18 months)

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

Quantification of microRNAs in Diagnosis of Pulmonary Nodules: Reproducibility Analysis of Intra- and Inter-observer and Inter-laboratory: Project miR-Nod

Acronym: miR-Nod

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Sep 26, 2017
Registry last updated
Jul 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.