Case-Control Study of Germ Cell Testicular Cancer Among U.S. Servicemen
Information source: National Institutes of Health Clinical Center (CC)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Testicular Germ Cell Cancer
Phase: N/A
Status: Active, not recruiting
Sponsored by: National Cancer Institute (NCI)
Summary
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.
Clinical Details
Official title: A Case-Control Study of Testicular Germ Cell Cancer Among U.S. Military Servicemen
Study design: N/A
Detailed description:
The incidence of testicular germ cell tumors (TGCT) has increased during the better part of
the twentieth century and is of particular concern as it primarily affects young men. Though
the tumor is relatively infrequent in the population as a whole, TGCT is the most common
cancer among U. S. males in the age group 25-34 years. Despite the increases in TGCT rates,
the etiology is still poorly understood. The only well described risk factors for TGCT are
cryptorchism, family history of TGCT and personal history of TGCT. Therefore, in order to
understand better 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
the years 1989 and 2003. All DoDSR donors who have developed GCT will be matched to DoDSR
donors who have not developed TGCT.
A total of 1682 servicemen were enrolled in the study; 754 cases and 928 controls. Of these
participants, 1303 men (77%, 590 cases, 713 controls) donated buccal cell samples. In
addition to the servicemen, a total of 1090 mothers of servicemen were enrolled and 952 (87%)
provided a buccal specimen. The DoDSR serum samples have now been sent to laboratories to be
assayed for levels of organochlorines and gonadotropins (FSH, LH, Inhibin B). Facility to be
typed for polymorphysms in the hormone metabolism and immune function pathways. Statistical
analyses of the questionnaire data have commenced.
Eligibility
Minimum age: 17 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
- INCLUSION CRITERIA:
The identification of men who have had a diagnosis of testicular germ cell tumor (TCGT)
will be accomplished by the linking of databases maintained by the Department of Defense.
Potential cases will be initially identified through the Defense Medical Surveillance
System (DMSS).
Matched controls will be identified through the DMSS.
Criteria for Cases include:
Age between 17 and 45 years at time of confirmed TGCT diagnosis.
Age of at least 18 years at time of study enrollment.
The existence of a pre-diagnostic serum sample of 1mL or greater in the DoDSR.
On active duty at time of diagnosis.
Donated a serum sample to the DoDSR between the years 1989 and 2003.
Criteria for Control Identification:
Case subjects will be matched with case men on age, ethnicity, and date of serum donation
to men in the DoDSR who have never had a diagnosis of TGCT (control men).
Criteria for Control Men include:
No previous diagnosis of TGCT.
Donated a serum sample to the DpDSR between the years 1989 and 2003.
Alive at study initiation.
On active duty at time of case's diagnosis.
Locations and Contacts
Walter Reed Army Medical Center, Washington, District of Columbia 20301, United States
Additional Information
Starting date: January 2002
Last updated: March 7, 2008
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