Study of Individuals and Families at High Risk for Testicular Cancer - Full Text View

Sponsor:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00039598

Purpose

RATIONALE: Studying members of families with testicular cancer may help to identify genetic susceptibility.

PURPOSE: Study to identify new families with familial testicular cancer to determine genetic susceptibility.

Condition	Intervention
Childhood Germ Cell Tumor Extragonadal Germ Cell Tumor Ovarian Cancer Testicular Germ Cell Tumor	Genetic: genetic linkage analysis Other: biologic sample preservation procedure Other: laboratory biomarker analysis Procedure: psychosocial assessment and care Procedure: quality-of-life assessment

Study Type:	Observational
Official Title:	Multidisciplinary Etiologic Study Of Familial Testicular Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Ovarian Cancer Testicular Cancer

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Ascertain new families with familial testicular germ cell tumors (TGCT)
Characterize the clinical features (phenotype) of familial TGCT with data acquired through medical history, physical examination, dysmorphology examination, imaging studies, and laboratory samples
Underlying genetic mechanism for susceptibility to TGCT in families by genome-wide linkage analysis, dense genotyping marker panels targeted at candidate regions, positional cloning, candidate gene testing through collaboration with the International ...
Evaluate various parameters related to psychosocial and behavioral issues resulting from being a member of a family at increased risk of TGCT by assessing genetic knowledge, interest in genetic testing, reproductive decision-making, quality of life, ...
Create a repository of biological samples from members of high-risk families for subsequent etiologic and translational research by collection of serum, plasma, whole blood, DNA, semen, and tumor tissue

Estimated Enrollment:	750
Study Start Date:	May 2002
Estimated Primary Completion Date:	December 2015 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Identify new families with familial testicular germ cell tumors (TGCT).
Determine the clinical features of familial TGCT.
Determine the underlying genetic mechanism for susceptibility to familial TGCT.
Determine the various parameters related to psychosocial and behavioral issues resulting from being a member of a family at increased risk of TGCT.

OUTLINE: This is a two-part study.

Part 1 (genetic study): Participants contribute DNA for analysis. Participants also complete personal and family medical history, risk factor exposure, and psychosocial and behavioral questionnaires.
Part 2 (etiology study): Participants undergo clinical evaluation including physical exam, blood tests, and imaging studies (CT scan or MRI and ultrasound) of the chest, abdomen, pelvis, and gonads.

A certificate of confidentiality protecting the identity of research participants in this project has been issued by the National Cancer Institute.

Participants do not receive the results of the genetic analysis, which is aimed at finding new testicular cancer susceptibility genes. The results do not influence the type or duration of treatment. Genetic testing for mutations in known genes cannot be performed, as none of these genes have yet been identified.

Participants are followed annually for 5 years.

PROJECTED ACCRUAL: Approximately 750 participants will be accrued for this study within 5 years.

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

DISEASE CHARACTERISTICS:

Members of families with familial testicular germ cell tumor (TGCT) defined by 1 of the following:
- At least 2 documented cases of germ cell tumor (at least 1 of which is testicular in origin) in blood relatives
- A single family member with bilateral testicular cancer
- Men with a history of TGCT who are one in a set of identical siblings
  - The unaffected identical sibling must also agree to participate in the study
TGCT case defined as histologically confirmed germ cell-derived tumor arising in the testis
- Seminoma
- Germinoma
- Embryonal carcinoma
- Endodermal sinus (yolk sac) tumor
- Gonadoblastoma
- Choriocarcinoma
- Teratoma
- Mixed germ cell tumor
- Extragonadal germ cell tumors allowed
Eligible individuals from participating families include:
- All TGCT patients
- All GCT patients, including those with ovarian or extragonadal germ cell tumors
- All first-degree relatives of each TGCT patient
- Spouse of every TGCT patient if the spouse and patient had children who are participating in the study
- Any other blood relative who genetically links 2 patients
- Any blood relative with cancer other than TGCT
Families of deceased TGCT patients are eligible only if the surviving spouse and children are willing to participate in the study
Critical informative family members must be willing to participate

PATIENT CHARACTERISTICS:

Age:

12 and over

Performance status:

Not specified

Life expectancy:

Not specified

Hematopoietic:

Not specified

Hepatic:

Not specified

Renal:

Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

Not specified

Endocrine therapy:

Not specified

Radiotherapy:

Not specified

Surgery:

Not specified

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00039598

Locations

United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office	Recruiting
Bethesda, Maryland, United States, 20892-1182
Contact: CGB Family Studies Research Nurse 800-518-8474

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

Principal Investigator:	Christian Kratz	NCI - Medical Genetics Branch
Study Chair:	Larissa Korde, MD, MPH	National Cancer Institute (NCI)

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Web site for additional information This link exits the ClinicalTrials.gov site

Featured trial article This link exits the ClinicalTrials.gov site

Publications:

Mai PL, Korde L, Kramer J, Peters J, Mueller CM, Pfeiffer S, Stratakis CA, Pinto PA, Bratslavsky G, Merino M, Choyke P, Linehan WM, Greene MH. A possible new syndrome with growth-hormone secreting pituitary adenoma, colonic polyposis, lipomatosis, lentigines and renal carcinoma in association with familial testicular germ cell malignancy: A case report. J Med Case Reports. 2007 Mar 28;1:9.

Mueller CM, Korde L, Katki HA, Rosenberg PS, Peters JA, Greene MH. Constitutional cytogenetic analysis in men with hereditary testicular germ cell tumor: no evidence of disease-related abnormalities. Cancer Epidemiol Biomarkers Prev. 2007 Dec;16(12):2791-4. No abstract available.

Peters JA, Vadaparampil ST, Kramer J, Moser RP, Court LJ, Loud J, Greene MH. Familial testicular cancer: interest in genetic testing among high-risk family members. Genet Med. 2006 Dec;8(12):760-70.

Rapley EA, Crockford GP, Easton DF, Stratton MR, Bishop DT; International Testicular Cancer Linkage Consortium. Localisation of susceptibility genes for familial testicular germ cell tumour. APMIS. 2003 Jan;111(1):128-33; discussion 33-5.

Study ID Numbers:	CDR0000069429, NCI-02-C-0178
Study First Received:	June 6, 2002
Last Updated:	November 16, 2009
ClinicalTrials.gov Identifier:	NCT00039598 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

stage I malignant testicular germ cell tumor
stage II malignant testicular germ cell tumor
stage III malignant testicular germ cell tumor
testicular choriocarcinoma and embryonal carcinoma
testicular choriocarcinoma and seminoma
testicular choriocarcinoma and teratoma
testicular choriocarcinoma and yolk sac tumor
testicular choriocarcinoma
testicular embryonal carcinoma and seminoma
testicular embryonal carcinoma and teratoma with seminoma
testicular embryonal carcinoma and teratoma
testicular embryonal carcinoma and yolk sac tumor with seminoma
testicular embryonal carcinoma and yolk sac tumor

testicular embryonal carcinoma
testicular seminoma
testicular teratoma
testicular yolk sac tumor and teratoma with seminoma
testicular yolk sac tumor and teratoma
testicular yolk sac tumor
childhood malignant testicular germ cell tumor
childhood teratoma
extragonadal germ cell tumor
stage I ovarian germ cell tumor
stage II ovarian germ cell tumor
childhood malignant ovarian germ cell tumor
childhood extragonadal germ cell tumor

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Ovarian Neoplasms
Genital Neoplasms, Male
Gonadal Disorders
Testicular Diseases
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Testicular Neoplasms

Ovarian Diseases
Genital Diseases, Male
Adnexal Diseases
Genital Diseases, Female
Neoplasms
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on November 27, 2009