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Testicular Germ Cell TumorTESTISNCT02109926

A Case-control Study to Assess the Association Between Environmental, Domestic and Occupational Exposures and the Risk of Testicular Germ Cell Tumor

An observational study of Testicular Germ Cell Tumor, run by Centre Leon Berard at 22 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 44 years, men onlyHealthy volunteers can take part
Conditions the study is for
Testicular Germ Cell Tumor
What is being tested?
Phone interview and blood test
How many people
1,367 participants
Where
22 sitesFrance
Study dates
Jan 2015to Apr 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 44 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Study population: 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.

Who may be able to join

  • Men aged between 18 and 44 years old
  • Born in metropolitan France
  • Able to understand, read and write French
  • Without any psychiatric and severe cognitive disorder
  • Willingness to participate to the study
  • Who has signed and dated an inform consent form
  • Affiliated to a health care system

Who cannot join

  • Who has a legal guardian
  • History of testicular germ cell tumor or cryptorchidism (only for controls)

Trial locations and contacts

22 sites in 1 country.

22 sites in 1 country

France22 sites

  • CHRU Jean Minjoz

    Besançon, 25030

  • CHU Jean Verdier

    Bondy, 93140

  • Maternité CHU Pellegrin

    Bordeaux, 33076

  • Hôpital Femme Mère Enfant

    Bron, 69677

  • CHU de Caen

    Caen, 14033

  • CHU Estaing

    Clermont-Ferrand, 63003

  • CHU Dijon

    Dijon, 21079

  • CHU de Grenoble - Hôpital Couple Enfants

    Grenoble, 38043

  • CHRU Lille - Hôpital Calmette

    Lille, 59037

  • Centre Léon Bérard

    Lyon, 69008

  • CHU La Conception

    Marseille, 13385

  • Hôpital Arnaud de Villeneuve

    Montpellier, 34295

  • Maternité Université Régionale

    Nancy, 74213

  • CHU de Nice - Hôpital l'Archet

    Nice, 06202

  • Hôpital Cochin

    Paris, 75014

  • Hôpital Tenon

    Paris, 75020

  • Hôpital Maison Blanche

    Reims, 51092

  • CHU de Rennes - Hôpital Sud

    Rennes, 35200

  • CHU Charles Nicolle

    Rouen, 76031

  • Centre Médico-Chirurgical Obstétrique

    Schiltigheim, 67303

  • Hôpital Paule de Viguier

    Toulouse, 31059

  • CHU Bretonneau

    Tours, 37000

Other trials in France

About this study

Official title: A Multicentric Case-control Study to Assess the Association Between Environmental, Domestic and Occupational Exposures During Antenatal and Early Postnatal Periods and the Risk to Develop a Testicular Germ Cell Tumor During Adulthood

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.

Read more

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.

Read the detailed description

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.

Being tested
Phone interview and blood test
Medical subject headings
Testicular Germ Cell Tumor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Phone interview and blood testOther

    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

Study groups in NCT02109926
Study groupRoleWhat they receive
Cases: testicular cancer patientsNot described
Receives: Other: Phone interview and blood test
Group A controlsSperm donors and husbands of women with fertility disorders All controls must have a normal spermogram
Receives: Other: Phone interview and blood test
Group B controlsHusbands of women with a pathological pregnancy
Receives: Other: Phone interview and blood test

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: at the end of enrollment (18 months)

Secondary outcomes (2)

  1. 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.

    Measured: at the end of enrollment (18 months)

  2. 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

    Measured: one year after the end of enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Apr 2014 (estimated)
  2. Study startJan 2015
  3. Primary completion30 Mar 2018
  4. Study completionApr 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Retrospective
Enrolment
1,367 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02109926
Sponsor's protocol ID
TESTIS
Other IDs
ET14-004, 140184B-12
Acronym
TESTIS
Status last verified
May 2018
First submitted
8 Apr 2014
Last updated
11 May 2018
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 18547762

  • Bray F, Richiardi L, Ekbom A, Forman D, Pukkala E, Cuninkova M, Moller H. Do testicular seminoma and nonseminoma share the same etiology? Evidence from an age-period-cohort analysis of incidence trends in eight European countries. Cancer Epidemiol Biomarkers Prev. 2006 Apr;15(4):652-8. doi: 10.1158/1055-9965.EPI-05-0565.

    PubMed 16614105

  • Dalgaard MD, Weinhold N, Edsgard D, Silver JD, Pers TH, Nielsen JE, Jorgensen N, Juul A, Gerds TA, Giwercman A, Giwercman YL, Cohn-Cedermark G, Virtanen HE, Toppari J, Daugaard G, Jensen TS, Brunak S, Rajpert-De Meyts E, Skakkebaek NE, Leffers H, Gupta R. A genome-wide association study of men with symptoms of testicular dysgenesis syndrome and its network biology interpretation. J Med Genet. 2012 Jan;49(1):58-65. doi: 10.1136/jmedgenet-2011-100174. Epub 2011 Dec 3.

    PubMed 22140272

  • Kanetsky PA, Mitra N, Vardhanabhuti S, Li M, Vaughn DJ, Letrero R, Ciosek SL, Doody DR, Smith LM, Weaver J, Albano A, Chen C, Starr JR, Rader DJ, Godwin AK, Reilly MP, Hakonarson H, Schwartz SM, Nathanson KL. Common variation in KITLG and at 5q31.3 predisposes to testicular germ cell cancer. Nat Genet. 2009 Jul;41(7):811-5. doi: 10.1038/ng.393. Epub 2009 May 31.

    PubMed 19483682

  • Kratz CP, Han SS, Rosenberg PS, Berndt SI, Burdett L, Yeager M, Korde LA, Mai PL, Pfeiffer R, Greene MH. Variants in or near KITLG, BAK1, DMRT1, and TERT-CLPTM1L predispose to familial testicular germ cell tumour. J Med Genet. 2011 Jul;48(7):473-6. doi: 10.1136/jmedgenet-2011-100001. Epub 2011 May 26.

    PubMed 21617256

  • Rapley EA, Turnbull C, Al Olama AA, Dermitzakis ET, Linger R, Huddart RA, Renwick A, Hughes D, Hines S, Seal S, Morrison J, Nsengimana J, Deloukas P; UK Testicular Cancer Collaboration; Rahman N, Bishop DT, Easton DF, Stratton MR. A genome-wide association study of testicular germ cell tumor. Nat Genet. 2009 Jul;41(7):807-10. doi: 10.1038/ng.394. Epub 2009 May 31.

    PubMed 19483681

  • Turnbull C, Rapley EA, Seal S, Pernet D, Renwick A, Hughes D, Ricketts M, Linger R, Nsengimana J, Deloukas P, Huddart RA, Bishop DT, Easton DF, Stratton MR, Rahman N; UK Testicular Cancer Collaboration. Variants near DMRT1, TERT and ATF7IP are associated with testicular germ cell cancer. Nat Genet. 2010 Jul;42(7):604-7. doi: 10.1038/ng.607. Epub 2010 Jun 13.

    PubMed 20543847

  • Chia VM, Li Y, Quraishi SM, Graubard BI, Figueroa JD, Weber JP, Chanock SJ, Rubertone MV, Erickson RL, McGlynn KA. Effect modification of endocrine disruptors and testicular germ cell tumour risk by hormone-metabolizing genes. Int J Androl. 2010 Aug 1;33(4):588-96. doi: 10.1111/j.1365-2605.2009.00975.x. Epub 2009 Jul 20.

    PubMed 19627379

  • Garner MJ, Turner MC, Ghadirian P, Krewski D. Epidemiology of testicular cancer: an overview. Int J Cancer. 2005 Sep 1;116(3):331-9. doi: 10.1002/ijc.21032.

    PubMed 15818625

  • Pukkala E, Weiderpass E. Socio-economic differences in incidence rates of cancers of the male genital organs in Finland, 1971-95. Int J Cancer. 2002 Dec 20;102(6):643-8. doi: 10.1002/ijc.10749.

    PubMed 12448008

  • Swerdlow AJ, Skeet RG. Occupational associations of testicular cancer in south east England. Br J Ind Med. 1988 Apr;45(4):225-30. doi: 10.1136/oem.45.4.225.

    PubMed 3377998

  • Swerdlow AJ, Douglas AJ, Huttly SR, Smith PG. Cancer of the testis, socioeconomic status, and occupation. Br J Ind Med. 1991 Oct;48(10):670-4. doi: 10.1136/oem.48.10.670.

    PubMed 1931725

  • Van den Eeden SK, Weiss NS, Strader CH, Daling JR. Occupation and the occurrence of testicular cancer. Am J Ind Med. 1991;19(3):327-37. doi: 10.1002/ajim.4700190307.

    PubMed 1848964

  • Sarfati D, Shaw C, Blakely T, Atkinson J, Stanley J. Ethnic and socioeconomic trends in testicular cancer incidence in New Zealand. Int J Cancer. 2011 Apr 1;128(7):1683-91. doi: 10.1002/ijc.25486. Epub 2010 Jun 1.

    PubMed 20518014

  • Chia VM, Quraishi SM, Devesa SS, Purdue MP, Cook MB, McGlynn KA. International trends in the incidence of testicular cancer, 1973-2002. Cancer Epidemiol Biomarkers Prev. 2010 May;19(5):1151-9. doi: 10.1158/1055-9965.EPI-10-0031.

    PubMed 20447912

Questions about this trial

What is this clinical trial studying?

An observational study of Testicular Germ Cell Tumor, run by Centre Leon Berard at 22 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assess the association between pesticide exposure during Antenatal and Early Postnatal Periods and the risk of testicular cancer during adulthood (time frame: at the end of enrollment (18 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02109926, which also lists 44 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2018.

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