Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00341588
Status:
COMPLETED
Last Update Posted:
2020-08-21
First Post:
2006-06-19
Brief Title:
A Case-Control Study of Testicular Germ Cell Tumors Among US Military Servicemen
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Case-Control Study of Testicular Germ Cell Tumors Among US Military Servicemen
Status:
COMPLETED
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 US 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 US 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 1080 men with TGCT 1080 controls and 2160 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 ie 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
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 ie 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 US 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 US 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 02-C-N113 | None | None | None |