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Home > "C" Clinical Trials Conditions > Clinical, Genetic, Behavioral, Laboratory and Epidemiologic Characterization of Individuals and Families at High Risk of Breast/Ovarian Cancer  Clinical, Genetic, Behavioral, Laboratory and Epidemiologic Characterization of Individuals and Families at High Risk of Breast/Ovarian Cancer
Clinical, Genetic, Behavioral, Laboratory and Epidemiologic Characterization of Individuals and Families at High Risk of Breast/Ovarian Cancer
For Condition: Ovarian Neoplasms,Breast Neoplasms
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This study is a syndrome-specific subset of a long-standing Genetic Epidemiology Branch, Human Genetics Program, Division of Cancer Epidemiology and Genetics 'umbrella' family studies protocol. Certain individuals and their relatives are asked to complete questionnaires and to undergo clinical evaluations related to the syndrome under study. They are monitored by periodic mail or telephone contact. Some return to the NIH Clinical Center for periodic follow-up examinations. They donate blood and tissue specimens for testing. The Hereditary Breast/Ovarian Cancer Family Studies Registry contains more than 3,000 individuals from 68 different families. They are candidates for various proposed National Cancer Institute (NCI) studies. This study may add individuals and families to that registry. This study will follow individuals and families at high risk of breast, ovarian, and other related cancers due to known or suspected genetic factors. Its primary goals include the following: - evaluate and define the disease in syndromes that predispose to familial breast or ovarian cancer - develop a resource of information on families predisposed to the diseases; track cancer occurrences and other diseases in such families - evaluate precursor states in members of such families - quantify their risk of specific tumors - identify genetic and environmental modifiers of cancer risk in members of such families - evaluate gene-gene and gene-environment interactions in the development of breast and ovarian cancer - create a repository of biospecimens for study The secondary goals of the study are to provide genetic counseling and germline mutation testing, with results disclosure when appropriate to those who desire it, and to develop syndrome-specific educational materials for members of high-risk families and medical professionals. Individuals and families potentially eligible for the study include the following: - Families with an unusual type, pattern, or number of tumors that include breast cancer or that are consistent with an identified or suspected familial cancer syndrome that includes breast and/or ovarian cancer - Individuals with a personal history of tumors or benign conditions of an unusual type or with unusual demographic features (e.g., young age of onset, multiple primary sites, rare tumor type) - Families of an individual with a known mutation in the BRCA1 or BRCA2 gene NOTE: At the present time, this protocol is considering referrals ONLY for persons who are known to carry mutations in the BRCA1 or BRCA2 genes.
Details: Individuals and families with known or suspected syndromes that include breast, ovarian or genetically-related cancers are enrolled in this family study, which is a syndrome- specific sub-set of the long-standing DCEG Human Genetics Program "umbrella" family studies protocol (78-C-0039). Cancer outcomes are documented through review of medical, vital, and pathology records. Selected individuals and family members are asked to complete questionnaires to assess etiologic risk factors and to undergo clinical evaluations specifically tailored to the relevant familial syndrome. Study participants are monitored prospectively for the development of outcomes of interest, typically by means of periodic mail or telephone contact. In selected instances, subjects may return to the Clinical Center periodically for study-specific follow-up examinations. Study participants are asked to donate biologic specimens to be used in the laboratory search for cancer etiology and mechanisms of carcinogenesis. DNA and serial samples will be collected. Tumor tissue will be obtained whenever feasible. Clinical genetic testing for tumor susceptibility gene(s) mutations and risk notification will be offered consistent with ASCO guidelines when reasonable individual cancer risk estimates can be delivered, and only to those participants who choose to know their individual genetic status after appropriate education and counseling. The testing will be conducted exclusively in Clinical Laboratory Improvement Amendments (CLIA)-licensed laboratories. Clinical genetic testing and risk notification are entirely optional and do not affect subject eligibility for other aspects of the protocol. A separate consent procedure and consent form will be used for genetic testing and risk notification. While we do not offer specific anti-cancer therapy as part of this protocol, we provide assistance to ensure that study participants who require treatment for problems that are identified or which develop during the course of the study are referred to appropriate health providers. We remain available to provide advice and consultation related to the management of the familial cancer syndrome to study participants and their health care providers.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: The following types of individuals and families would be potentially eligible for study: Families with neoplasias of an unusual type, pattern, or number which includes breast cancer or is consistent with an identified or suspected familial cancer syndrome which includes breast and/or ovarian cancer. Included in this category would be families with a history of cancer consistent with any of the known syndromes: the familial breast/ovarian syndrome, Li-Fraumeni syndrome, Peutz-Jegher, Cowden Syndrome. Families with multiple cases of breast cancer among first- and second- degree relatives and the occurrence of other cancers which do not fit into a well-characterized syndrome, would also be of potential interest. For example, we would be interested in studying families with the occurrence of multiple breast and colorectal cancers. Additionally, individuals with a personal history of neoplasia(s) or benign conditions of an unusual type or with unusual demographic features (young age of onset, multiple primary sites, rare tumor type of pathologic characteristics) may trigger an initial evaluation of the family. Families of an individual with a known mutation in the BRCA1 or BRCA2 gene would be eligible for enrollment. EXCLUSION CRITERIA: Individuals and families referred for evaluation in whom reported diagnoses are not verifiable. Inability to provide informed consent.
Total Enrollment: 1000
Location and Contact Information:
National Cancer Institute (NCI) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 020212; 02-C-0212
Study Start Date: June 20, 2002
Record last reviewed: June 3, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00040222
Other Breast Neoplasms Studies:
1. Clinical, Genetic, Behavioral, Laboratory and Epidemiologic Characterization of Individuals and Families at High Risk of Breast/Ovarian Cancer
2. Phase 3 Study of TLK286 vs. Doxil/Caelyx or Hycamtin in Platinum Refractory or Resistant Ovarian Cancer
3. Phase II Trial of Gleevec in Patients with Advanced Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
4. Safety/Efficacy Study of SGN-15 (Antibody-Drug Conjugate) Combined with Gemcitabine in Patients with Ovarian Cancer
5. EPO906 Therapy in Patients with Advanced Ovarian, Primary Fallopian, or Primary Peritoneal Cancer
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Clinical, Genetic, Behavioral, Laboratory and Epidemiologic Characterization of Individuals and Families at High Risk of Breast/Ovarian Cancer
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