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| ID | Type | Description | Link |
|---|---|---|---|
| ET14-004 | Other Identifier | Sponsor's number | |
| 140184B-12 | Other Identifier | ANSM's number |
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| Name | Class |
|---|---|
| National Cancer Institute, France | OTHER_GOV |
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
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The incidence of testicular germ cell tumors, the most common cancer in men aged 15 to 45 years, has doubled in France in 30 years. Reasons remain unclear but a role of environmental factors, especially during critical periods of development, is strongly suspected. Reliable data on environmental exposure during this critical period are sparse.The discordant findings and the limitations of available studies underline the importance to conduct studies with sufficient statistical power to detect risk due to exposures during critical windows of vulnerability.
We conduct a multicentric case-control study to assess this association. Cases and controls will be enrolled during a 18-month period. They will be interviewed by professional telephone interviewers about their occupational and residential history and about their domestic exposure to pesticides and other nuisances.
An optional biological study to assess genetic polymorphisms known to be associated with testicular cancer will be proposed to every cases and controls.
Mothers (or close relative) of cases and controls will also be contacted (with son's agreement). If they agree to participate, they will also be interviewed about antenatal and early life exposure of their sons to pesticides and other nuisances.
Cases will be matched up with 2 controls (one of each group) both on age (+/- 2 years) and on recruiting center.
Environmental exposure to pesticides will be assessed from subject's residential history, using a Geographic Information System.
Occupational exposure to pesticides and other nuisances will be assessed by an industrial hygienist who will be in charge to encode all subjects and mothers' occupations.
Domestic exposure to pesticides will be assessed from type, target and frequency of domestic pesticide use.
Based on these 3 sources of exposure, a score of exposition will be calculated for each case and each control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cases: testicular cancer patients |
| ||
| Group A controls | Sperm donors and husbands of women with fertility disorders All controls must have a normal spermogram |
| |
| Group B controls | Husbands of women with a pathological pregnancy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phone interview and blood test | Other | Subjects will be interviewed about environmental, domestic and occupational exposures during several periods of life Two blood samples will be collected at enrollment to study genetic polymorphisms |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the association between pesticide exposure during Antenatal and Early Postnatal Periods and the risk of testicular cancer during adulthood | Occupational, environmental and domestic exposures to pesticides and other nuisances will be assessed. | at the end of enrollment (18 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the association between a combined exposure to pesticides and the risk of testicular cancer during adulthood | The association will be assessed during antenatal, postnatal early life and later life (adolescence and adulthood). Occupational, environmental and domestic exposures to pesticides and other nuisances will be assessed. | at the end of enrollment (18 months) |
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Inclusion Criteria:
Exclusion Criteria:
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Cases are patients with a testicular germ cell tumor. They will be recruited in the French infertility centers at the moment of sperm cryopreservation.
Group A controls are sperm donors and husbands of women with fertility troubles. They will be recruited in the French infertility centers and in the medically assisted procreation centers.
Group B controls are husbands of women followed for a pathological pregnancy. This group of controls will be recruited in the level III maternities.
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| Name | Affiliation | Role |
|---|---|---|
| Béatrice FERVERS, MD | Centre Leon Berard | Principal Investigator |
| Joachim SCHÃœZ, PhD | International Agency for Research on Cancer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU Jean Minjoz | Besançon | 25030 | France | |||
| CHU Jean Verdier |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18547762 | Background | Belot A, Grosclaude P, Bossard N, Jougla E, Benhamou E, Delafosse P, Guizard AV, Molinie F, Danzon A, Bara S, Bouvier AM, Tretarre B, Binder-Foucard F, Colonna M, Daubisse L, Hedelin G, Launoy G, Le Stang N, Maynadie M, Monnereau A, Troussard X, Faivre J, Collignon A, Janoray I, Arveux P, Buemi A, Raverdy N, Schvartz C, Bovet M, Cherie-Challine L, Esteve J, Remontet L, Velten M. Cancer incidence and mortality in France over the period 1980-2005. Rev Epidemiol Sante Publique. 2008 Jun;56(3):159-175. doi: 10.1016/j.respe.2008.03.117. Epub 2008 Jun 10. | |
| 16614105 |
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plasma and buffy coat
| Analyse polymorphisms known to be associated with testicular cancer risk to explore gene-environment interactions | Polymorphisms involved in organochlorine metabolism pathways will also be assessed. Biological study | one year after the end of enrollment |
| Bondy |
| 93140 |
| France |
| Maternité CHU Pellegrin | Bordeaux | 33076 | France |
| Hôpital Femme Mère Enfant | Bron | 69677 | France |
| CHU de Caen | Caen | 14033 | France |
| CHU Estaing | Clermont-Ferrand | 63003 | France |
| CHU Dijon | Dijon | 21079 | France |
| CHU de Grenoble - Hôpital Couple Enfants | Grenoble | 38043 | France |
| CHRU Lille - Hôpital Calmette | Lille | 59037 | France |
| Centre Léon Bérard | Lyon | 69008 | France |
| CHU La Conception | Marseille | 13385 | France |
| Hôpital Arnaud de Villeneuve | Montpellier | 34295 | France |
| Maternité Université Régionale | Nancy | 74213 | France |
| CHU de Nice - Hôpital l'Archet | Nice | 06202 | France |
| Hôpital Cochin | Paris | 75014 | France |
| Hôpital Tenon | Paris | 75020 | France |
| Hôpital Maison Blanche | Reims | 51092 | France |
| CHU de Rennes - Hôpital Sud | Rennes | 35200 | France |
| CHU Charles Nicolle | Rouen | 76031 | France |
| Centre Médico-Chirurgical Obstétrique | Schiltigheim | 67303 | France |
| Hôpital Paule de Viguier | Toulouse | 31059 | France |
| CHU Bretonneau | Tours | 37000 | France |
| Background |
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| 37230752 | Derived | Guth M, Coste A, Lefevre M, Deygas F, Danjou A, Ahmadi S, Dananche B, Perol O, Boyle H, Schuz J, Bujan L, Metzler-Guillemain C, Giscard d'Estaing S, Teletin M, Ducrocq B, Frapsauce C, Olsson A, Charbotel B, Fervers B; TESTIS study group. Testicular germ cell tumour risk by occupation and industry: a French case-control study - TESTIS. Occup Environ Med. 2023 Jul;80(7):407-417. doi: 10.1136/oemed-2022-108601. Epub 2023 May 25. |
| ID | Term |
|---|---|
| C563236 | Testicular Germ Cell Tumor |
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| ID | Term |
|---|---|
| D006403 | Hematologic Tests |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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