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Etiosarc: Environmental Aetiology of Sarcomas From a Multicenter French Population-based Case-control Study Among Adults (ETIOSARC)

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ClinicalTrials.gov Identifier: NCT03670927
Recruitment Status : Recruiting
First Posted : September 14, 2018
Last Update Posted : May 10, 2019
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France

Brief Summary:

Introduction: Sarcomas are rare tumors of connective tissue. The exact overall incidence of sarcomas is unknown due to diagnostic difficulties and the various histological subtypes (over 80 subtypes). However, the apparent increasing incidence of sarcomas suggests environmental causes such as pesticides. Except for some specific factors (i.e. ionizing radiation, vinyl chloride, dioxin, and genetic predispositions) the scientific knowledge on the aetiology of sarcomas is sparse and inconsistent. France is a particularly appropriate country to set up a study investigating the causes of sarcoma occurrence due to the French organization in treatment and care of sarcoma patients, which is highly structured and revolved around national expert networks. The main objective of the ETIOSARC project is to study the role of lifestyle, environmental and occupational factors in the occurrence of sarcomas among adults from a multicentric population-based case-control study.

Methods and analysis: Cases will be all incident cases (older than 18 years old) identified in 15 districts of France covered by a cancer registry and/or a reference center in sarcoma's patient care over a three-year period with an inclusion start date ranging from the 1st October 2018 to the 1st January 2020 and histologically confirmed by a second review of the diagnosis. Two controls will be individually-matched by sex, age (5-years group), and districts of residence and randomly selected from electoral list. A standardized questionnaire will be administered by a trained interviewer in order to gather information about occupational and residential history, demographic and socioeconomic characteristics and lifestyle factors. At the end of the interview, a saliva sample will be systematically proposed.

This study will permit to validate or not already suspected risk factors for sarcomas such as phenoxyherbicides, chlorophenol and to generate new hypothesis to increase our understanding about the genetic and environmental contributions in the carcinogenicity process.


Condition or disease Intervention/treatment
Sarcoma Environmental Exposure Occupational Exposure Life Style Other: Environmental, occupational and lifestyle-related exposures

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 6462 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Etiosarc: Study of the Environmental Aetiology (Environment, Occupations and Lifestyle) of Sarcomas (Soft Tissue, Visceral and Bone) From a Multicenter French Population-based Case-control Study Among Adults.
Actual Study Start Date : April 25, 2019
Estimated Primary Completion Date : April 15, 2020
Estimated Study Completion Date : April 28, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Cases
Cases (incident patients with a diagnosis of primary sarcoma and histologically confirmed by an expert pathologist of the RRePS or ResOs networks in the 15 districts of France participating to this study) Environmental, occupational and lifestyle-related exposures
Other: Environmental, occupational and lifestyle-related exposures
A standardized questionnaire will be administered by a trained interviewer in order to gather information about occupational and residential history, demographic and socioeconomic characteristics and lifestyle factors. At the end of the interview, a saliva sample will be systematically proposed

Controls

Subjects never diagnosed with a primary sarcoma and individually-matched by sex, age (5-years group), and districts of residence and randomly selected from electoral list.

Environmental, occupational and lifestyle-related exposures

Other: Environmental, occupational and lifestyle-related exposures
A standardized questionnaire will be administered by a trained interviewer in order to gather information about occupational and residential history, demographic and socioeconomic characteristics and lifestyle factors. At the end of the interview, a saliva sample will be systematically proposed




Primary Outcome Measures :
  1. Odds ratios measuring the association between environmental exposures under study (environmental, occupational and lifestyle exposures) and sarcoma occurence [ Time Frame: 1 year ]
    The relationship between case/control status and each exposure variable will be estimated by odds ratios and their 95% confidence intervals using conditional logistic regression models.


Biospecimen Retention:   Samples With DNA
Each participant will be asked to provide a salivary sample in order to obtain germline DNA. Salivary samples will be collected by the subjects themselves under instructions from the CRA, using DNA Genotek Oragene 575 collection kit. After collection, samples will be sent at the Biological Resources Center of the Bordeaux hospital university center "Bordeaux Biothèque Santé" for storage.


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:   Yes
Sampling Method:   Probability Sample
Study Population

Cases are defined as all incident patients with a diagnosis of primary sarcoma and histologically confirmed by an expert pathologist of the RRePS or ResOs networks in the 15 districts of France participating to this study.

Two control subjects per case will be randomly selected from the French general population using electoral rolls and individually matched to case by age (by 5-year age group), sex and residential area.

Criteria

Inclusion Criteria:

  • Cases

    • Patients diagnosed in the previous 6 months from identification with a primary and histologically confirmed malignant sarcoma including soft-tissue, visceral and bone sarcomas as defined by the WHO classification of bones and soft tissue sarcoma, fourth edition, 2013;
    • Diagnosed over a three-year period with an inclusion start date ranging from the 1st October 2018 to the 1st January 2020;
    • Living in the 15 districts participating to the study at the time of diagnosis
    • French nationality (due to control selection within electoral lists);
    • At least 18 years old at diagnosis;
    • Agreed to participate to the study with a signed informed consent;
  • Controls

    • Subjects registered within the electoral rolls;
    • At least 18 years old at interview;
    • Living in the 15 districts participating to the study at the time of interview;
    • Agreed to participate to the study with a signed informed consent;

Exclusion Criteria:

  • Cases

    • Patients with a known genetic predisposition to sarcoma such as Li-Fraumeni syndrome, Retinoblastoma syndrome, neurofibromatosis;
    • Kaposi's' sarcoma;
    • Protected adults' patients (aged of at least 18 years old) under guardianship by court order.
  • Controls

    • Subject previously diagnosed with a primary and histologically confirmed malignant sarcoma including soft-tissue, visceral and bone sarcomas as defined by the WHO classification of bones and soft tissue sarcoma, fourth edition, 2013;
    • Protected adults' patients (aged of at least 18 years old) under guardianship by court order.

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): NCT03670927


Contacts
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Contact: Aude Lacourt, PhD +3357571623 aude.lacourt@inserm.fr
Contact: Brice Amadéo, PhD +33557574775 brice.amadeo@u-bordeaux.fr

Locations
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France
CHRU Recruiting
Besançon, France
Contact: Loïc CHAIGNEAU         
Institut Bergonié Recruiting
Bordeaux, France
Contact: Antoine ITALIANO         
Sub-Investigator: Thierry FABRE         
Centre François Baclesse Recruiting
Caen, France
Contact: Corinne DELCAMBRE LAIR         
Centre Oscar Lambret Recruiting
Lille, France
Contact: Nicolas PENEL         
Sub-Investigator: Carlos MAYNOU         
CHU Dupuytren Recruiting
Limoges, France
Contact: Fabrice FIORENZA         
Sub-Investigator: Valérie LEBRUN-LY         
Centre Léon Bérard Recruiting
Lyon, France
Contact: Jean-Yves BLAY         
Sub-Investigator: Isabelle RAY-COQUARD         
Institut régional du Cancer Montpellier Recruiting
Montpellier, France
Contact: Didier CUPISSOL         
CHU Recruiting
Nantes, France
Contact: François GOUIN         
Sub-Investigator: Emmanuelle BOMPAS         
CHRU Recruiting
Strasbourg, France
Contact: Jean-Emmanuel Kurtz         
Sub-Investigator: Antonio DI MARCO         
Institut Gustave Roussy Recruiting
Villejuif, France
Contact: Axel LE CESNE         
Sub-Investigator: Gilles MISSENARD         
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
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Principal Investigator: Aude Lacourt, PhD French National Institute of Health and Medical Research

Publications:
IARC (2012). IARC Monographs on the Evaluation of Carcinogenic Risks to Humans, Vol. 100. A review of human carcinogens, part D: radiation. Lyon, IARC (International Agency for Research on Cancer)
IARC (2012). IARC Monographs on the Evaluation of Carcinogenic Risks to Humans, Vol. 100. A review of human carcinogens, part F: chemical agents and related occupations. Lyon, IARC (International Agency for Research on Cancer)

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT03670927     History of Changes
Other Study ID Numbers: C17-03
First Posted: September 14, 2018    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized individual participant data for both cases and controls will be made available under request to the principal investigator
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data will be available at any time
Access Criteria: Data access requests will be reviewed by the steering committee Requestors will be required to sign a Data Access Agreement

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms