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Study on Fluids Associated to Lung Cancer (ECTOPIC/MUTAS)

Primary Purpose

Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood and respiratory fluids sampling
Biopsy
Excised tissues
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lung Cancer focused on measuring Cancer lung, Fluids, LungCancerTest, radiological anomalies, non-cancerous, carriers, Patient reference

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criterias :

  • 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 Criterias :

  • 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.

Sites / Locations

  • UniversityHospitalGrenoble

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Group 1 lung cancer in stage 1-2

Group 2 lung cancer in stage 3-4

Group 3 : control patients

Arm Description

Group 1 : patient with lung cancer in stage 1-2, lung cancer of all histology kind eligible for surgery

Group 2 : patient with lung cancer in stage 3-4 (no adenocarcinoma or squamous) receiving classical or targeted chemotherapy on genetic anomalies.

Group 3 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.

Outcomes

Primary Outcome Measures

Quantification of : DNA
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
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).

Secondary Outcome Measures

Full Information

First Posted
July 13, 2016
Last Updated
March 17, 2020
Sponsor
University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT02853006
Brief Title
Study on Fluids Associated to Lung Cancer
Acronym
ECTOPIC/MUTAS
Official Title
Study on Fluids Associated to Lung Cancer, of the Ectopic Expression of Cancer Testis Gene and Mutation as Diagnostics and Prognosis Biomarkers
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
September 2019 (Actual)
Study Completion Date
February 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
Cancer lung, Fluids, LungCancerTest, radiological anomalies, non-cancerous, carriers, Patient reference

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 lung cancer in stage 1-2
Arm Type
Other
Arm Description
Group 1 : patient with lung cancer in stage 1-2, lung cancer of all histology kind eligible for surgery
Arm Title
Group 2 lung cancer in stage 3-4
Arm Type
Other
Arm Description
Group 2 : patient with lung cancer in stage 3-4 (no adenocarcinoma or squamous) receiving classical or targeted chemotherapy on genetic anomalies.
Arm Title
Group 3 : control patients
Arm Type
Other
Arm Description
Group 3 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.
Intervention Type
Biological
Intervention Name(s)
Blood and respiratory fluids sampling
Intervention Description
In order to extract RNA (LungCancerTest) and DNA (mutation, reassortment).
Intervention Type
Procedure
Intervention Name(s)
Biopsy
Intervention Type
Procedure
Intervention Name(s)
Excised tissues
Primary Outcome Measure Information:
Title
Quantification of : DNA
Description
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.
Time Frame
Half a day
Title
Quantification of : RNA
Description
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).
Time Frame
Half a day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criterias : 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 Criterias : 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Brambilla, Professor
Organizational Affiliation
Grenoble Hospital University
Official's Role
Principal Investigator
Facility Information:
Facility Name
UniversityHospitalGrenoble
City
La Tronche
ZIP/Postal Code
38700
Country
France

12. IPD Sharing Statement

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Ythier D, Brambilla E, Binet R, Nissou D, Vesin A, de Fraipont F, Moro-Sibilot D, Lantuejoul S, Brambilla C, Gazzeri S, Pedeux R. Expression of candidate tumor suppressor gene ING2 is lost in non-small cell lung carcinoma. Lung Cancer. 2010 Aug;69(2):180-6. doi: 10.1016/j.lungcan.2009.11.006. Epub 2009 Dec 4.
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Larrieu D, Ythier D, Binet R, Brambilla C, Brambilla E, Sengupta S, Pedeux R. ING2 controls the progression of DNA replication forks to maintain genome stability. EMBO Rep. 2009 Oct;10(10):1168-74. doi: 10.1038/embor.2009.180. Epub 2009 Sep 4.
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19482469
Citation
Cassidy A, Balsan J, Vesin A, Wu X, Liloglou T, Brambilla C, Timsit JF, Field JK; EUELC Consortium. Cancer diagnosis in first-degree relatives and non-small cell lung cancer risk: results from a multi-centre case-control study in Europe. Eur J Cancer. 2009 Nov;45(17):3047-53. doi: 10.1016/j.ejca.2009.05.006. Epub 2009 May 29.
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PubMed Identifier
19211441
Citation
Delloye-Bourgeois C, Brambilla E, Coissieux MM, Guenebeaud C, Pedeux R, Firlej V, Cabon F, Brambilla C, Mehlen P, Bernet A. Interference with netrin-1 and tumor cell death in non-small cell lung cancer. J Natl Cancer Inst. 2009 Feb 18;101(4):237-47. doi: 10.1093/jnci/djn491. Epub 2009 Feb 10.
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PubMed Identifier
19123267
Citation
Brambilla C. From surgical to molecular scalpel: ERJ lung cancer series for 2009. Eur Respir J. 2009 Jan;33(1):9-10. doi: 10.1183/09031936.00162908. No abstract available.
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PubMed Identifier
19096006
Citation
Verri C, Roz L, Conte D, Liloglou T, Livio A, Vesin A, Fabbri A, Andriani F, Brambilla C, Tavecchio L, Calarco G, Calabro E, Mancini A, Tosi D, Bossi P, Field JK, Brambilla E, Sozzi G; EUELC Consortium. Fragile histidine triad gene inactivation in lung cancer: the European Early Lung Cancer project. Am J Respir Crit Care Med. 2009 Mar 1;179(5):396-401. doi: 10.1164/rccm.200807-1153OC. Epub 2008 Dec 18.
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PubMed Identifier
18974389
Citation
Van Den Broeck A, Brambilla E, Moro-Sibilot D, Lantuejoul S, Brambilla C, Eymin B, Gazzeri S. Loss of histone H4K20 trimethylation occurs in preneoplasia and influences prognosis of non-small cell lung cancer. Clin Cancer Res. 2008 Nov 15;14(22):7237-45. doi: 10.1158/1078-0432.CCR-08-0869. Epub 2008 Oct 30. Erratum In: Clin Cancer Res. 2020 Jun 1;26(11):2767. Clin Cancer Res. 2020 Jun 1;26(11):2768.
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PubMed Identifier
18806759
Citation
Merdzhanova G, Edmond V, De Seranno S, Van den Broeck A, Corcos L, Brambilla C, Brambilla E, Gazzeri S, Eymin B. E2F1 controls alternative splicing pattern of genes involved in apoptosis through upregulation of the splicing factor SC35. Cell Death Differ. 2008 Dec;15(12):1815-23. doi: 10.1038/cdd.2008.135. Epub 2008 Sep 19.
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PubMed Identifier
18636562
Citation
Ythier D, Larrieu D, Brambilla C, Brambilla E, Pedeux R. The new tumor suppressor genes ING: genomic structure and status in cancer. Int J Cancer. 2008 Oct 1;123(7):1483-90. doi: 10.1002/ijc.23790.
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PubMed Identifier
18535523
Citation
Bertrand D, Righini C, Ferretti G, Brambilla C, Moro-Sibilot D. [Early diagnosis of bronchial carcinoma after head and neck cancer]. Rev Mal Respir. 2008 May;25(5):559-68. doi: 10.1016/s0761-8425(08)71613-9. French.
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PubMed Identifier
18347513
Citation
Ferretti GR, Jankowski A, Rodiere M, Brichon PY, Brambilla C, Lantuejoul S. CT-guided biopsy of nonresolving focal air space consolidation. J Thorac Imaging. 2008 Feb;23(1):7-12. doi: 10.1097/RTI.0b013e3181453e04.
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PubMed Identifier
18238942
Citation
Brambilla C, Colonna M. Cannabis: the next villain on the lung cancer battlefield? Eur Respir J. 2008 Feb;31(2):227-8. doi: 10.1183/09031936.00157607. No abstract available.
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