A Case-Control Study of Testicular Germ Cell Tumors Among U.S. Military Servicemen

NCT00341588 | Completed

• 2 other identifiers: 99990211302-C-N113
• Study Type: observational
• Target: 2,772
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Testicular Cancer

Keywords

Testicular Cancer; Epidemiology; Testicular Germ Cell Cancer; TGCT; Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

• environmental and genetic determinants of TGCT risk

  16 years

Study Arms (2)

Cases

Male U.S. serviceman, age 18-45 years old with TGCT

Controls

Male U.S. serviceman, age 18-45 years old without TGCT

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male U.S. servicemen, age 18-45 years old, with atleast one serum sample stored in the DoD Serum Repository.

You may qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Cancer Institute (NCI), 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

Testicular Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Endocrine System Diseases; Testicular Diseases; Gonadal Disorders

Study Officials

• Katherine A McGlynn, Ph.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2006
• First Posted: June 21, 2006
• Study Start: January 18, 2002
• Primary Completion: October 1, 2008
• Study Completion: August 18, 2020
• Last Updated: August 21, 2020

Record last verified: 2020-08

Locations

US (1)