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NCT00341588
A Case-Control Study of Testicular Germ Cell Tumors Among U.S. Military Servicemen
trial in Testicular Cancer in 2,772 participants. Completed in 18 August 2020.
1 October 2008
Quick facts
| Lead sponsor | National Cancer Institute (NCI) |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 2,772 |
| Start date | 18 January 2002 |
| Primary completion | 1 October 2008 |
| Estimated completion | 18 August 2020 |
| Sites | 1 location across United States |
Conditions studied
- Testicular Cancer — all drugs for Testicular Cancer →
Sponsor
National Cancer Institute (NCI)
Who can join
Adults 18 to 120, male only, with Testicular Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The incidence of testicular germ cell tumors (TGCT) has increased during the twentieth century and is of particular concern as it primarily affects young men. It is the most common cancer among U.S. males ages 25-34. The only well-described risk factors are cryptorchism (undescended testis), family history of TGCT, and personal history of TGCT. To better understand the environmental and genetic determinants of TGCT risk, a case-control study will be conducted among members of the U.S. armed forces. The study will include men who have donated a blood sample to the Department of Defense Serum Repository (DoDSR) between 1989 and 2000. All DoDSR donors who have developed GCT will be matched to DoDSR donors who have not developed TGCT. Approximately 1,080 men with TGCT, 1,080 controls, and 2,160 mothers will be included in the study. The DoDSR serum sample will be tested for organochlorines levels, gonadotropin levels, and viral antibody titres. Each participant will donate a saliva specimen that will be used in an examination of genetic susceptibility. Each participant will also complete a questionnaire concerning a variety of possible risk factors such as physical activity, medical history, medication history, and other risk factors. The mothers of all participants will be invited to participate by completing a questionnaire concerning perinatal exposures and events and by donating a saliva sample. The three main objectives of this study are to: * determine whether environmental endocrine modulators (i.e., chlorinated pesticides and polychlorinated biphenyls) are related to risk of GCT and, if so, whether their effects are augmented by other risk factors. * determine whether genetic susceptibility to GCT exists and to characterize the environmental risk factors related to that susceptibility. * determine whether there are distinct causes of GCT by relating the tissue structures of the tumors to the risk factors.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00341588
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00341588 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Cancer Institute (NCI)
- Last refreshed: 21 August 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00341588.
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