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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02853006
Recruitment Status : Completed
First Posted : August 2, 2016
Last Update Posted : March 19, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

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.


Condition or disease Intervention/treatment Phase
Lung Cancer Biological: Blood and respiratory fluids sampling Procedure: Biopsy Procedure: Excised tissues Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 Start Date : June 2015
Actual Primary Completion Date : September 2019
Actual Study Completion Date : February 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Group 1 lung cancer in stage 1-2
Group 1 : patient with lung cancer in stage 1-2, lung cancer of all histology kind eligible for surgery
Biological: Blood and respiratory fluids sampling
In order to extract RNA (LungCancerTest) and DNA (mutation, reassortment).

Procedure: Excised tissues
Group 2 lung cancer in stage 3-4
Group 2 : patient with lung cancer in stage 3-4 (no adenocarcinoma or squamous) receiving classical or targeted chemotherapy on genetic anomalies.
Biological: Blood and respiratory fluids sampling
In order to extract RNA (LungCancerTest) and DNA (mutation, reassortment).

Procedure: Biopsy
Group 3 : control patients
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.
Biological: Blood and respiratory fluids sampling
In order to extract RNA (LungCancerTest) and DNA (mutation, reassortment).




Primary Outcome Measures :
  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).




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02853006


Locations
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France
UniversityHospitalGrenoble
La Tronche, France, 38700
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
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Principal Investigator: Christian Brambilla, Professor Grenoble Hospital University
Publications:
BRAMBILLA C., ROUSSEAUX S., DE BERNARDI A., JACQUIAU B., VITTE A.L., ARBIB F., LEMAITRE N., LANTUEJOUL S., MIGNOTTE H, MORO-SIBILOT D., TOFFART A.C., BRAMBILLA E., KOCHBIN S. A PCR-based test detecting ectopic expressions of placenta/germline genes can predict aggressive lung tumours. J. Thor. Oncol. • Volume 8, Supplement 2, November 2013 S1048
PEIFER M, FERNÁNDEZ-CUESTA L, SOS ML, GEORGE J, SEIDEL D, KASPER LH, PLENKER D, LEENDERS F, SUN R, ZANDER T, MENON R, KOKER M, DAHMEN I, MÜLLER C, DI CERBO V, SCHILDHAUS HU, ALTMÜLLER J, BAESSMANN I, BECKER C, DE WILDE B, VANDESOMPELE J, BÖHM D, ANSÉN S, GABLER F, WILKENING I, HEYNCK S, HEUCKMANN JM, LU X, CARTER SL, CIBULSKIS K, BANERJI S, GETZ G, PARK KS, RAUH D, GRÜTTER C, FISCHER M, PASQUALUCCI L, WRIGHT G, WAINER Z, RUSSELL P, PETERSEN I, CHEN Y, STOELBEN E, LUDWIG C, SCHNABEL P, HOFFMANN H, MULEY T, BROCKMANN M, ENGEL-RIEDEL W, MUSCARELLA LA, FAZIO VM, GROEN H, TIMENS W, SIETSMA H, THUNNISSEN E, SMIT E, HEIDEMAN DA, SNIJDERS PJ, CAPPUZZO F, LIGORIO C, DAMIANI S, FIELD J, SOLBERG S, BRUSTUGUN OT, LUND-IVERSEN M, SÄNGER J, CLEMENT JH, SOLTERMANN A, MOCH H, WEDER W, SOLOMON B, SORIA JC, VALIDIRE P, BESSE B, BRAMBILLA E, BRAMBILLA C, LANTUEJOUL S, LORIMIER P, SCHNEIDER PM, HALLEK M, PAO W, MEYERSON M, SAGE J, SHENDURE J, SCHNEIDER R, BÜTTNER R, WOLF J, NÜRNBERG P, PERNER S, HEUKAMP LC, BRINDLE PK, HAAS S, THOMAS RK. Integrative genome analyses identify key somatic driver mutations of small-cell lung cancer.Nat Genet. 2012;44(10):1104-10
Bousquet J, Anto JM, Sterk PJ, Adcock IM, Chung KF, Roca J, Agusti A, Brightling C, Cambon-Thomsen A, Cesario A, Abdelhak S, Antonarakis SE, Avignon A, Ballabio A, Baraldi E, Baranov A, Bieber T, Bockaert J, Brahmachari S, Brambilla C, Bringer J, Dauzat M, Ernberg I, Fabbri L, Froguel P, Galas D, Gojobori T, Hunter P, Jorgensen C, Kauffmann F, Kourilsky P, Kowalski ML, Lancet D, Pen CL, Mallet J, Mayosi B, Mercier J, Metspalu A, Nadeau JH, Ninot G, Noble D, Oztürk M, Palkonen S, Préfaut C, Rabe K, Renard E, Roberts RG, Samolinski B, Schünemann HJ, Simon HU, Soares MB, Superti-Furga G, Tegner J, Verjovski-Almeida S, Wellstead P, Wolkenhauer O, Wouters E, Balling R, Brookes AJ, Charron D, Pison C, Chen Z, Hood L, Auffray C. Systems medicine and integrated care to combat chronic noncommunicable diseases. Genome Med. 2011 Jul 6;3(7):43. doi: 10.1186/gm259.
Travis WD, Brambilla E, Noguchi M, Nicholson AG, Geisinger KR, Yatabe Y, Beer DG, Powell CA, Riely GJ, Van Schil PE, Garg K, Austin JH, Asamura H, Rusch VW, Hirsch FR, Scagliotti G, Mitsudomi T, Huber RM, Ishikawa Y, Jett J, Sanchez-Cespedes M, Sculier JP, Takahashi T, Tsuboi M, Vansteenkiste J, Wistuba I, Yang PC, Aberle D, Brambilla C, Flieder D, Franklin W, Gazdar A, Gould M, Hasleton P, Henderson D, Johnson B, Johnson D, Kerr K, Kuriyama K, Lee JS, Miller VA, Petersen I, Roggli V, Rosell R, Saijo N, Thunnissen E, Tsao M, Yankelewitz D. International association for the study of lung cancer/american thoracic society/european respiratory society international multidisciplinary classification of lung adenocarcinoma. J Thorac Oncol. 2011 Feb;6(2):244-85. doi: 10.1097/JTO.0b013e318206a221. Review.
Weiss J, Sos ML, Seidel D, Peifer M, Zander T, Heuckmann JM, Ullrich RT, Menon R, Maier S, Soltermann A, Moch H, Wagener P, Fischer F, Heynck S, Koker M, Schöttle J, Leenders F, Gabler F, Dabow I, Querings S, Heukamp LC, Balke-Want H, Ansén S, Rauh D, Baessmann I, Altmüller J, Wainer Z, Conron M, Wright G, Russell P, Solomon B, Brambilla E, Brambilla C, Lorimier P, Sollberg S, Brustugun OT, Engel-Riedel W, Ludwig C, Petersen I, Sänger J, Clement J, Groen H, Timens W, Sietsma H, Thunnissen E, Smit E, Heideman D, Cappuzzo F, Ligorio C, Damiani S, Hallek M, Beroukhim R, Pao W, Klebl B, Baumann M, Buettner R, Ernestus K, Stoelben E, Wolf J, Nürnberg P, Perner S, Thomas RK. Frequent and focal FGFR1 amplification associates with therapeutically tractable FGFR1 dependency in squamous cell lung cancer. Sci Transl Med. 2010 Dec 15;2(62):62ra93. doi: 10.1126/scitranslmed.3001451. Erratum in: Sci Transl Med. 2011 Jan 19;3(66):66er2. Sci Transl Med. 2012 Apr 18;4(130):130er2.

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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT02853006    
Other Study ID Numbers: 38RC15.099
First Posted: August 2, 2016    Key Record Dates
Last Update Posted: March 19, 2020
Last Verified: March 2020
Keywords provided by University Hospital, Grenoble:
Cancer lung
Fluids
LungCancerTest
radiological anomalies
non-cancerous
carriers
Patient reference
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases