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NCT03670927Completed

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

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.

Source: ClinicalTrials.gov · Last updated 7 Nov 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
2237 (actual)
First submitted
12 Sept 2018
Start date
25 Apr 2019
Primary completion date
3 Jul 2024
Lead sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Diseases
Sarcoma
NCT number
NCT03670927

What you commit to

  • Study type: Observational
  • Participants enrolled: 2237
  • From 25 Apr 2019 to the primary completion date, 3 Jul 2024
  • 10 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Age

  • 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.

Who the study is looking for

  • 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;

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (10)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CHRU
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BesançonFranceUnknown status
Institut Bergonie
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BordeauxFranceUnknown status
Centre François Baclesse
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CaenFranceUnknown status
Centre Oscar Lambret
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LilleFranceUnknown status
Chu Dupuytren
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LimogesFranceUnknown status
Centre Leon Berard
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LyonFranceUnknown status
Institut Régional du Cancer Montpellier
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MontpellierFranceUnknown status
CHU
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NantesFranceUnknown status
CHRU
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StrasbourgFranceUnknown status
Institut Gustave Roussy
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VillejuifFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.