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Completed

NCT Number: NCT02853006

Study on Fluids Associated to Lung Cancer

The diagnosis of lung cancer is the first cause of cancer deaths for man and woman. It requires invasive procedures (at least endoscopy, transthoracic puncture, or surgery).

This study is about the set up of an innovative test for lung cancer prognosis, based on biopsies and surgical material : LungCancerTest, with the creation of a start-up in progress.

The main goal of this study is to approve the diagnostic value of the molecular signature of the 26 genes (LungCancerTest) revealed in blood and respiratory fluids among patients with lung cancer.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UniversityHospitalGrenoble

La Tronche, 38700, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

s :

  • Patients with lung cancer in stage 1-2, lung cancer of all histology kind eligible for surgery (Group 1).
  • Patients with lung cancer in stage 3-4 (no adenocarcinoma or squamous) receiving classical or targeted chemotherapy on genetic anomalies (Group 2).
  • Control patients : carriers of non-cancerous radiological anomalies : benign nodules, cicatricial lesions, infectious or inflammatory, paired with the two other groups by age, sex or tobacco (Group 3).
  • Adults patients : over 18 years.
  • Persons affiliated to national social security.
  • Free signed consent.

Exclusion criteria

s :

  • Persons referred to in articles L1121-5 to L1121-8 of CSP ( protected people) : pregnants, parturients or breastfeeding women, person deprived of liberty by judicial or administrative decision, person under legal protection.

Treatment and study plan

Blood and respiratory fluids sampling

Biological

In order to extract RNA (LungCancerTest) and DNA (mutation, reassortment).

Biopsy

Procedure

Excised tissues

Procedure

Primary outcomes

  1. Quantification of : DNA

    Time frame: Half a day

    From plasma or respiratory fluids, with Qiagen QIAamp MinElute Virus Spin kit.

    Picogreen technique (fluorimétrie) with the device Qubit 2.0 Characterization of DNA by migration on revealed agarose gel in presence of ethidium bromide

    Study of DNA (mutation, reassortment) with New Generation Sequencing materiel.

  2. Quantification of : RNA

    Time frame: Half a day

    From plasma or respiratory fluids, with Qiagen QIAamp MinElute Virus Spin kit.

    Picogreen technique (fluorimétrie) with the device Qubit 2.0 Characterization of RNA with an Agilent chip

    Study of RNA (LungCancerTest) with PCR-Array prototype to show the expression of the molecular signature (Cancer Testis genes).

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

Study on Fluids Associated to Lung Cancer, of the Ectopic Expression of Cancer Testis Gene and Mutation as Diagnostics and Prognosis Biomarkers

Acronym: ECTOPIC/MUTAS

Important dates

Study start
2015
Primary completion
2019
Study completion
2020
First posted
Aug 2, 2016
Registry last updated
Mar 19, 2020

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.

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