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Home > "S" Clinical Trials Conditions > Study of the Cause of Familial Testicular Cancer  Study of the Cause of Familial Testicular Cancer
Study of the Cause of Familial Testicular Cancer
For Condition: Germinoma,Testicular Neoplasms
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This protocol will study the risk of testicular cancer in men with a family history of the disease. It will try to: 1) find the gene or genes responsible for familial testicular cancer; 2) characterize the clinical features of the disease; 3) determine how best to prevent familial testicular cancer; 4) determine if other types of cancer occur more often than expected in families with multiple cases of testicular cancer; and 5) examine emotional issues of members of a family at increased risk of testicular cancer. People with a family history of testicular cancer-defined as at least two cases of testicular cancer in blood relatives or a single family member with cancer in both testicles-may be eligible for this study. Those enrolled may participate in part 1 or parts 1 and 2 of this two-part study. Participants will undergo the tests and procedures described below. Part 1 - Genetic Study - Provide a blood or cheek cell sample to obtain DNA (hereditary material) for testing to identify genes related to the inherited form of testicular cancer. No more than 40 milliliters (about 3 tablespoons) of blood will be collected. Cheek cells will be collected by swishing a mouthwash and spitting into a container. Blood samples (DNA, serum, plasma) will be stored for future laboratory research aimed at reaching a better understanding of the causes of familial testicular cancer. - Fill out questionnaires providing information about: 1) personal and family medical history; 2) exposure to various factors that might influence the risk of testicular cancer; and 3) mood, attitudes and feelings related to being a member of a family in which several relatives have developed testicular cancer. - Give permission to obtain past medical records and pathology material related to cancer and related illnesses, and give permission to obtain medical records and pathology materials from deceased relatives for whom the participant is the next of kin or legally authorized representative. Part 2 - Clinical Evaluation - All participants: medical history and routine tests, such as blood drawing. - All adults: complete physical examination; computed tomography (CT) scan of the chest, abdomen and pelvis. CT uses x-rays to produce images of the kidneys, bladder, lungs, and other internal organs. - Males: examination of the testicles and scrotum; ultrasound (test that uses sound waves to produce images) of the testicles and scrotum; and semen sample (in men ages 18 and above) to check for measures of fertility. - Females: pelvic examination to check the ovaries, uterus and fallopian tubes.
Details: This project will enroll individuals affected by Familial Testicular Cancer and their families. Eligible individuals include: 1. those with a history of bilateral testicular germ cell tumor (TGCT), 2. those individuals from a family in which two or more blood relatives have had TGCT, or 3. males with a history of TGCT who have a monozygotic twin brother. This project consists of two parts. In the first sub-study, individuals and family members will be asked to contribute baseline questionnaire information and DNA for gene mapping and cloning efforts that are being done in collaboration with the International Testicular Cancer Linkage Consortium. The primary goal of this effort is to identify the susceptibility genes that are involved in familial testicular cancer. One specific goal is to confirm, and then to clone, the hereditary testicular cancer gene which has been mapped to chromosome Xq27. Study participants will also complete questionnaires regarding family history, personal medical history, exposure to various factors that may affect TGCT risk, as well as lifestyle, feelings, attitudes and behavior that relate to being part of a high-risk family. In the second sub-study, these same participants will be offered an opportunity to travel to the Clinical Center for a detailed, etiologically-oriented clinical evaluation. This evaluation includes a comprehensive history and physical examination, laboratory testing, ultrasound imaging of the gonads, and imaging studies of the chest, abdomen, and pelvis. Study participants will then be monitored prospectively for the development of outcomes of interest by means of periodic mail and/or telephone contact. Cancer outcomes will be documented through review of medical, vital, and pathology records. Tumor tissue will be obtained whenever feasible. The primary objectives are to: 1. Ascertain new families with familial testicular germ cell tumors; 2. Characterize the clinical features of familial TGCT; 3. Determine the underlying genetic mechanism for susceptibility to TGCT in families; and 4. Evaluate various parameters related to psychosocial and behavioral issues resulting from being a member of a family at increased risk of TGCT.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Study population: Patients must be members of families with familial TGCT as defined below. Definition of familial TGCT: The criterion establishing familial TGCT is the presence of: -at least two cases of documented GCT in blood relatives (at least one of which is testicular in origin), OR -a single family member with bilateral testicular cancer, OR -men with a history of TGCT who are one in a set of identical siblings will also be included in the study (in which case both twins must agree to participate. Case definition: A case will be determined to have TGCT according to the following criteria: -Pathologic confirmation of a germ cell-derived tumor arising in the testis. Extragonadal germ cell tumors will also be included. -Germ cell-derived histologies including: seminoma, germinoma, embryonal carcinoma, endodermal sinus (yolk sac) tumor, gonadoblastoma, choriocarcinoma, teratoma, and mixed germ cell tumor. -A case will be determined to have TIN on the basis of pathologic confirmation of intratubular malignant germ cells (ITMGCs) as defined by Burke and Mostofi. Individuals from participating families who are eligible for this study include: i) all TGCT cases; ii) All GCT cases (including those of ovarian or extra-gonadal sites); iii) all first-degree relatives of each TGCT case; iv) the spouse(s) of every case if the spouse and case had children who are participating in the study; v) any blood relative not included in (ii - iii) above who genetically links two cases; and vi) any blood relative with cancer other than TGCT vii) family members as described in i) - v) above must be age 12 or greater in order to participate The inclusion criteria were expanded to include (as eligible) families in which one of a set of identical siblings has been diagnosed with testicular cancer. In recognition that archival sources of tissue for genotyping may be available (such as tissue blocks or stored stem cells), families with a deceased case will be eligible if such a source of DNA is available and can be released for genotyping. EXCLUSION CRITERIA: Families will be deemed ineligible for participation in this study if: There are not at least two proven cases of GCT in the family, one of which is testicular in origin, unless there is a family member with bilateral testicular cancer or a case occurs in one of identical twins; If the identical sibling of a case is unwilling to participate (and there are no other cases of GCT in the family); Critical informative family members are unwilling to participate (i.e., unwilling to provide written informed consent);
Total Enrollment: 750
Location and Contact Information:
National Cancer Institute (NCI) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Mark Greene 3015947642
Additional Information:
Study ID Numbers: 020178; 02-C-0178
Study Start Date: April 24, 2002
Record last reviewed: March 18, 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00034424
Other Germinoma Studies:
1. Study of the Cause of Familial Testicular Cancer
Related Studies:
Other Germinoma Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Study of the Cause of Familial Testicular Cancer
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