Study on Fluids Associated to Lung Cancer

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02853006

Acronym

ECTOPIC/MUTAS

Enrollment

Registered

2016-08-02

Start date

2015-06-30

Completion date

2020-02-29

Last updated

2020-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

Cancer lung, Fluids, LungCancerTest, radiological anomalies, non-cancerous, carriers, Patient reference

Brief summary

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.

Interventions

BIOLOGICALBlood and respiratory fluids sampling

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

PROCEDUREBiopsy

PROCEDUREExcised tissues

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Quantification of : DNA	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.
Quantification of : RNA	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).

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026