Testicular CancerNCT00341588
A Case-Control Study of Testicular Germ Cell Tumors Among U.S. Military Servicemen
An observational study of Testicular Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years, men only
- Conditions the study is for
- Testicular Cancer
- How many people
- 2,772 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2002to 18 Aug 2020
- 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 120 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Male U.S. servicemen, age 18-45 years old, with atleast one serum sample stored in the DoD Serum Repository.
Who may be able to join
- 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.
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- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Cancer Institute (NCI), 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
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.
Read more
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.
Read the 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 15-34 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 been assayed for levels of organochlorines pesticides, polychlorinated biphenyl congeners, insulin-like growth factors and gonadotropins and steroid hormones. DNA isolated from the buccal cell specimens have thus far been genotyped for polymorphysms in the hormone metabolism and immune function pathway, immune function pathway, insulin-like growth factor pathway and for single nucleotide polymorphisms in the 8q24 locus. In addition, a genome-wide association study has completed. Statistical analyses of the questionnaire data are continuing.
- Conditions
- Testicular Cancer
- Keywords
- Testicular Cancer, Epidemiology, Testicular Germ Cell Cancer, TGCT, Healthy Volunteer
- Medical subject headings
- Testicular Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cases | Male U.S. serviceman, age 18-45 years old with TGCT | |
| Controls | Male U.S. serviceman, age 18-45 years old without TGCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
environmental and genetic determinants of TGCT risk
Measured: 16 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study start18 Jan 2002
- Primary completion1 Oct 2008
- Study completion18 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Testicular CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 2,772 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Katherine A McGlynn, Ph.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00341588
- Sponsor's protocol ID
- 999902113
- Other IDs
- 02-C-N113
- Status last verified
- Aug 2020
- First submitted
- 19 Jun 2006
- Last updated
- 21 Aug 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Case-Control Study of Testicular Germ Cell Tumors Among U.S. Military Servicemen
- ClinicalTrials.gov ID
- NCT00341588
- Acronym / sponsor ID
- 999902113
- Conditions
- Testicular Cancer
- Keywords
- Testicular Cancer, Epidemiology, Testicular Germ Cell Cancer, TGCT, Healthy Volunteer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,772 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 18 Jan 2002 (actual)
- Primary completion
- 1 Oct 2008 (actual)
- Study completion
- 18 Aug 2020 (actual)
- First posted
- 21 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 15-34 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 been assayed for levels of organochlorines pesticides, polychlorinated biphenyl congeners, insulin-like growth factors and gonadotropins and steroid hormones. DNA isolated from the buccal cell specimens have thus far been genotyped for polymorphysms in the hormone metabolism and immune function pathway, immune function pathway, insulin-like growth factor pathway and for single nucleotide polymorphisms in the 8q24 locus. In addition, a genome-wide association study has completed. Statistical analyses of the questionnaire data are continuing.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | –Male U.S. serviceman, age 18-45 years old with TGCT |
| Controls | – | –Male U.S. serviceman, age 18-45 years old without TGCT |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male U.S. servicemen, age 18-45 years old, with atleast one serum sample stored in the DoD Serum Repository.
Key inclusion criteria (15 listed)
- 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.
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
environmental and genetic determinants of TGCT risk
Time frame: 16 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine A McGlynn, Ph.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Testicular Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
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 15 inclusion and 0 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 21 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
environmental and genetic determinants of TGCT risk (time frame: 16 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Aug 2020.