Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Mesothelioma

Mesothelioma, Malignant

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Mesothelial

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Pleural Neoplasms

Lung Diseases

Respiratory Tract Diseases

Malignant Mesothelioma

Individuals who have been diagnosed with mesothelioma

Jill Ohar, MD

Lee Krug, MD

Julie Brahmer, MD

Harvey I Pass, MD

Tobias Peikert, MD

Daniel H Sterman, MD

The purpose of this research study is to investigate the possibility that a person's genes put a person at a higher risk of developing mesothelioma. The investigators will examine genes from DNA (genetic material) isolated from blood. This study will also examine the impact of environmental and work exposures and family history of common cancers on the development of mesothelioma. The genetic markers in this study will basically identify how a person's body processes frequently encountered environmental pollutants and will not tell about chromosomes, specific diseases, or other potential health problems.

Mesothelioma is a cancer that develops from serosal surfaces usually in response to prior asbestos exposure. A history of asbestos exposure can be elicited in more than 80% of mesothelioma victims. However, asbestos exposure alone is not sufficient to cause the development of mesothelioma. Nearly 27 million individuals in the US, were exposed to asbestos in the work place between 1940 and 1979 but just 3,000 new cases of mesothelioma are diagnosed each year. Therefore, the investigators hypothesis is that genetic variation in addition to asbestos exposure, and host factors contribute to the development of mesothelioma. It is estimated, based on the investigators preliminary studies, that a population in excess of 1,000 subjects with mesothelioma is required to perform a valid GWAS.

Therefore a multicenter approach is necessary to collect data and DNA on sufficient numbers with mesothelioma to adequately evaluate genetic risk. It is the aim of this proposal to develop a consortium of mesothelioma investigators to share phenotypic data and DNA samples and to perform genome wide association scanning (GWAS).

Do Your Genes Put You at a Higher Risk of Developing Mesothelioma

Consortium for the Sharing of Germ Line DNA and Tissue From Subjects With Mesothelioma

Demographic variables that will be collected include; date of birth, gender, age at first exposure to asbestos, type of exposure (occupational or bystander), family health history, personal past medical history, smoking history, age at diagnosis, latency, tumor location and cell type.

Given the significant risk for cancers other than the index mesothelioma in both subjects and their 1st degree relative (nearly 3 fold for sibs, parents and the mesothelioma subjects themselves and 7 fold for their children), the goal is to identify SNPs involved with mesothelioma and other common cancer susceptibility.

University of Pennsylvania

Mayo Clinic

NYU Langone Health

Johns Hopkins University

Memorial Sloan Kettering Cancer Center

Mesothelioma Applied Research Foundation, Inc.

Wake Forest University

Jean-Claude Pairon, Pr

Fleur Delva, MD

Patrick Brochard, Pr

Catherine Verdun-Esquer, MD

David LUCAS, Dr

Jean-Dominique Dewitte, MD

Bénédicte Clin-Godart, Pr

Nadia Abdessemed, MD

Pascal Andujar, Pr

Mireille Matrat, MD

Christophe Paris, Pr

Jean-François Gehanno, Pr

Antoine Gislard, MD

Olivier Bylicki, Dr

Olivier Bylicki, MD

The good clinical practice guidelines for the surveillance of workers after occupational exposure to lung carcinogens were approved by the Haute Autorité de la Santé (French National Authority for Health) and the Institut National du Cancer (French National Cancer Institute) in December 2015 and one recommendation of these guidelines concerns the setting-up of a trial of low-dose chest computed tomography (CT) lung cancer screening in subjects occupationally exposed to lung carcinogens at high-risk of lung cancer (Expert consensus).

In LUCSO study, the investigators propose to conduct, under strictly defined conditions, a feasibility study of lung cancer screening in a population defined as being at high risk of lung cancer according to these good clinical practice guidelines. This population consists of smokers, aged from 55 to 74 years, currently or previously exposed to International Agency for Research on Cancer lung group 1 lung carcinogens.

The primary objective of this study is to evaluate the complex organization of lung cancer screening in the target population. This evaluation will focus on the following indicators:

* Screening activity indicator: screening coverage rate over two years
* Test quality indicator: validity of self-administered questionnaires to target the high-risk population
* Examination quality indicator: lung cancer detection rate, lung cancer detection rates by stage, validity of low-dose chest CT scan
* Follow-up indicator: smoking cessation rate, mortality rate This trial will be conducted in 8 French departments, by six reference centers specialized in occupational health (SRC).

In view of the exploratory nature of this trial, it is proposed to initially test the feasibility and acceptability of lung cancer screening sequentially over the first two years (Phase 1: 2021-2023, 24 months) in only two SRC (Val-de-Marne and Gironde).

The trial will be conducted in several steps:

1. Identification of subjects currently or previously occupationally exposed to lung carcinogens by a screening invitation letter sent by Departmental Cancer Screening Centers to subjects aged from 55 to 74 years.
2. Evaluation of occupational exposure to lung carcinogens
3. Evaluation of the lung cancer risk level and verification of eligibility
4. Screening procedure: Chest CT scans will be performed by centers specialized in chest imaging
5. Lung cancer follow-up when an abnormality suggestive of lung cancer is demonstrated.

The good clinical practice guidelines for the surveillance of workers after occupational exposure to lung carcinogens were approved by the Haute Autorité de la Santé (French National Authority for Health) and the Institut National du Cancer (French National Cancer Institute) in December 2015 and the Recommendation R12 of these guidelines concerns the setting-up of a trial of low-dose chest computed tomography (CT) lung cancer screening in subjects occupationally exposed to lung carcinogens at high-risk of lung cancer (Expert consensus).

In LUCSO study, the investigators propose to conduct, under strictly defined conditions, a feasibility study of lung cancer screening in a population defined as being at high risk of lung cancer according to these good clinical practice guidelines. This population consists of smokers, aged from 55 to 74 years, currently or previously exposed to International Agency for Research on Cancer lung group 1 lung carcinogens.

The primary objective of this study is to evaluate the organization of lung cancer screening in the target population. This evaluation will focus on the following indicators:

* Screening activity indicator: screening coverage rate over two years
* Test quality indicator: validity of self-administered questionnaires to target the high-risk population
* Examination quality indicator: lung cancer detection rate, lung cancer detection rates by stage, validity of low-dose chest CT scan
* Follow-up indicator: smoking cessation rate, mortality rate

The secondary objectives of the study are:

* Describe the population recruited in each step of the protocol
* Develop a tool to identify subjects exposed to pulmonary carcinogens and with high-risk of lung cancer
* Evaluate the impact of the proposed screening programme on smoking cessation at one, two and three years.
* Evaluate the social impact of the screening campaign
* Conduct a cost-effectiveness analysis of the programme

The proposed study will take place in multidisciplinary and specialized reference centers (SRC) in various French districts participating in the programme, to welcome patients participating. It is organized into six workpackages (WP):

* WP1: Methodology - Epidemiology
* WP2: Evaluation of occupational exposure
* WP3: Imaging
* WP4: Lung cancer follow-up strategy
* WP5: Smoking cessation
* WP6: Medico-economic analysis Six specialized reference centers are proposed in four different regions in order to test a potential region effect and to allow the recruitment by each SRC of about 200 to 600 new eligible subjects per year and per department according to the population and the age pyramid of each department
* SRC1: Centre Intercommunal de Créteil for the Val-de-Marne (94), Seine-et-Marne (77), and Essonne (91) departments
* SRC2: Bordeaux University Hospital for the Gironde (33) department
* SRC3: Rennes University Hospital for the Ille-et-Vilaine (35) department
* SRC4: Brest University Hospital for the Finistère (29) department
* SRC5: Caen University Hospital for the Calvados (14) department
* SRC6: Rouen University Hospital for the Seine-Maritime (76) department

Each of these centers is voluntary and possesses the four essential prerequisites: an occupational health clinic - radiology team with specific skills in chest imaging - pulmonology team or network of pulmonologists specialized in lung cancer - smoking cessation team.

In view of the complexity of this organization, it is proposed to initially test the feasibility and acceptability of the screening programme sequentially for the first two years (24 months) in two SRCs (SRC1 and SRC2): "Phase 1: 2021-2023". It is expected to extend the study to the other SRCs after two years: "Phase 2: 2023-2029". Ad hoc adjustments will be decided for the creation of SRCs in the third year on the basis of the data acquired in the two pilot departments, especially on the expected target population participation rate. Mortality will be monitored at least until 2031.

The trial will be conducted in several steps:

1. Identification of subjects currently or previously occupationally exposed to lung carcinogens by a screening invitation letter sent by Departmental Cancer Screening Centers to subjects aged from 55 to 74 years.
2. Evaluation of occupational exposure to lung carcinogens
3. Evaluation of the lung cancer risk level and verification of eligibility
4. Screening procedure: Chest CT scans will be performed by centers specialized in chest imaging
5. Lung cancer follow-up when an abnormality suggestive of lung cancer is demonstrated.

Lung Cancer Screening in a Population Exposed to Occupational Lung Carcinogens

LUng Cancer Screening With Low-dose Computed Tomography in a Population Exposed to Occupational Lung Carcinogens

The proportion of subjects with lung cancer detected among the subjects performing the low-dose chest CT scan

The proportion of subjects performing the low-dose chest CT scan among eligible responders during the first phase of the study

The proportion of subjects with lung cancer detected among the subjects exposed to occupational carcinogens and performing the low-dose chest CT scan

The proportion of subjects with smoking cessation among smokers

University Hospital, Bordeaux

Rennes University Hospital

Centre Hospitalier Régional et Universitaire de Brest

University Hospital, Caen

Centre Hospitalier Universitaire de Rouen

Direction Centrale du Service de Santé des Armées

Centre Hospitalier Intercommunal Creteil

Cholangiocarcinoma

Adenocarcinoma

Carcinoma

Bile Duct Cancer

Intrahepatic Cholangiocarcinoma

All Drugs and Chemicals

Nicotine

Patients committed to surgery and stratified according to exposure to different risk factors for ICC, basing on modified ReNaM questionnaire.

exposure to different risk factors and molecular assessment

Giovanni Brandi

Jody Corbelli

Simona Tavolari

Maria Aurelia Barbera

The aim of the present study is to perform a comprehensive molecular characterization of intrahepatic cholangiocarcinoma (ICC) in patients exposed to well-known or putative risk factors (such as asbestos) for this malignancy, in order to identify possible "molecular signatures" associated to such different risk factors.

Exposure to distinct risk factors of the enrolled ICC patients will be assessed by modified ReNaM questionnaire. Molecular characterization of ICC tissue samples will be carried out by RNAseq. Briefly, after surgical resection tissue samples will be immediately suspended in RNAlater. RNAseq analysis will be performed on the Illumina HiScanSQ platform. Any possible mutations identified by RNAseq will be validated by Sanger sequencing. Putative identified fusion transcripts will be confirmed by RT-PCR, using specific primers pairs located on the sequences from the exons of the two putative fusion genes. Variations in gene expression will be validated by the real-time PCR. The bioinformatic analysis will be made by using CentOS5 Server. For evaluation of asbestos fibers in tumor tissues, samples embedded in paraffin will be incinerated and then analyzed in a scanning electron microscope and by EDS spectroscopy.

Tumor tissue samples will be immediately collected after surgery: one part will be suspended in RNAlater to prevent RNA degradation and stored at -20°C, the other will be formalin-fixed and paraffin-embedded for histopathology examination and evaluation of asbestos fibers. For each patient enrolled, peripheral blood will be also collected and stored at -20°C. Total RNA and genomic DNA will be extracted from tumor tissue and peripheral blood and stored at -80°C until use.

Next Generation Sequencing in Intrahepatic Cholangiocarcinoma

Next Generation Sequencing in Intrahepatic Cholangiocarcinoma (ICC) According to the Stratification of the Risk Factors

For each patient enrolled, molecular profile of ICC tissue samples will be correlated to the anamnestic data collected by modified ReNaM questionnaire. For bio-informatic analysis, the collected data will be analyzed in order to identify signals that significantly deviate from the expected SNVs distribution in the general population, then analyzing the presence of clustering for the selected genes group. A two-way unsupervised hierarchical clustering analysis will be run to assess gene expression in the study groups (exposed / unexposed to the different risk factors). Random permutation test will be also conducted to assess the presence of genes whose expression is different in the study groups. Statistical analyses will be conducted using the R software (R Foundation and for Statistical Computing).

University of Bologna

Prof, MD, PhD

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Do Your Genes Put You at a Higher Risk of Developing Mesothelioma	NCT01590472	Mesothelioma		18 Years -	Wake Forest University Health Sciences
Do Your Genes Put You at a Higher Risk of Developing Mesothelioma	NCT01590472	Mesothelioma		18 Years -	Wake Forest University Health Sciences
Lung Cancer Screening in a Population Exposed to Occupational Lung Carcinogens	NCT03562052	Lung Cancer		55 Years - 74 Years	Centre Hospitalier Intercommunal Creteil
Next Generation Sequencing in Intrahepatic Cholangiocarcinoma	NCT02184871	Intrahepatic Ch...	exposure to dif...	18 Years -	University of Bologna

Spots Global Cancer Trial Database for asbestos

Every month we try and update this database with for asbestos cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for asbestos

Every month we try and update this database with for asbestos cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for asbestos cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.