Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00040222
Status:
COMPLETED
Last Update Posted:
2024-07-03
First Post:
2002-06-22
Brief Title:
Clinical Genetic Behavioral Laboratory and Epidemiologic Characterization of Individuals and Families at High Risk of BreastOvarian Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Clinical Genetic Behavioral Laboratory and Epidemiologic Characterization of Individuals and Families at High Risk of BreastOvarian Cancer
Status:
COMPLETED
Status Verified Date:
2024-08-19
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:
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 serum samples will be collected Tumor tissue will be obtained whenever feasible
Clinical genetic testing for tumor susceptibility genes 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
This protocol developed in response to recommendations developed by the Clinical Center IRB is intended to
1 Provide a mechanism under which the Clinical Genetics Branch can honor the commitment made to the members of over 60 hereditary breastovarian cancer families which have been participated in various Human Genetics Program research studies conducted over the past 3 decades to provide genetic counseling
clinical germline mutation testing and consultative services now that several of the major breastovarian cancer susceptibility genes have been identified
2 Provide a mechanism through which new families with various familial syndromes associated with an increased risk of breast and ovarian cancer can be studied as research interests in these syndromes evolve over time and
3 Create a resource of well-characterized carefully documented high-risk families to facilitate the development of new etiologic and translational research studies in the future
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 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
Clinical genetic testing for tumor susceptibility genes 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
This protocol developed in response to recommendations developed by the Clinical Center IRB is intended to
1 Provide a mechanism under which the Clinical Genetics Branch can honor the commitment made to the members of over 60 hereditary breastovarian cancer families which have been participated in various Human Genetics Program research studies conducted over the past 3 decades to provide genetic counseling
clinical germline mutation testing and consultative services now that several of the major breastovarian cancer susceptibility genes have been identified
2 Provide a mechanism through which new families with various familial syndromes associated with an increased risk of breast and ovarian cancer can be studied as research interests in these syndromes evolve over time and
3 Create a resource of well-characterized carefully documented high-risk families to facilitate the development of new etiologic and translational research studies in the future
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 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
Detailed Description:
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 serum samples will be collected Tumor tissue will be obtained whenever feasible
Clinical genetic testing for tumor susceptibility genes 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
This protocol developed in response to recommendations developed by the Clinical Center IRB is intended to
1 Provide a mechanism under which the Clinical Genetics Branch can honor the commitment made to the members of over 60 hereditary breastovarian cancer families which have been participated in various Human Genetics Program research studies conducted over the past 3 decades to provide genetic counseling clinical germline mutation testing and consultative services now that several of the major breastovarian cancer susceptibility genes have been identified
2 Provide a mechanism through which new families with various familial syndromes associated with an increased risk of breast and ovarian cancer can be studied as research interests in these syndromes evolve over time and
3 Create a resource of well-characterized carefully documented high-risk families to facilitate the development of new etiologic and translational research studies in the future
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 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
Clinical genetic testing for tumor susceptibility genes 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
This protocol developed in response to recommendations developed by the Clinical Center IRB is intended to
1 Provide a mechanism under which the Clinical Genetics Branch can honor the commitment made to the members of over 60 hereditary breastovarian cancer families which have been participated in various Human Genetics Program research studies conducted over the past 3 decades to provide genetic counseling clinical germline mutation testing and consultative services now that several of the major breastovarian cancer susceptibility genes have been identified
2 Provide a mechanism through which new families with various familial syndromes associated with an increased risk of breast and ovarian cancer can be studied as research interests in these syndromes evolve over time and
3 Create a resource of well-characterized carefully documented high-risk families to facilitate the development of new etiologic and translational research studies in the future
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 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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-0212 | None | None | None |