Patient Selection
PreOvar® KRAS –variant Test Populations:
1.Women who have been diagnosed with ovarian cancer (1)* (independent of their BRCA1/BRCA2 mutational status), who:
Essential patient information: (1) ovarian cancer including type/stage; (2) pedigree if available;
BRCA1/BRCA2 test result if available, i.e. negative, positive - specify mutation or gene variant
2. Women who have been diagnosed with triple negative premenopausal breast cancer (2) (independent of their BRCA1/BRCA2 mutations status), who:
Essential patient information: (1) pedigree if available; (2) breast cancer status including type if available; (3) BRCA1/BRCA2 test result if available, i.e. negative, positive - specify mutation or genetic variant
3. Women considered at high risk for developing ovarian cancer (independent of their cancer status and/or BRCA1/BRCA2 mutational status) because they are 1° or 2° relatives of an affected member of an HBOC family containing any of the following:
Essential patient information: (1) pedigree if available; (2) breast cancer status including type if available; (3) BRCA1/BRCA2 test result if available, i.e. negative, positive - specify mutation or genetic variant
*epithelial ovarian/fallopian tube/primary peritoneal
(NOTE: The Laboratory Director and/or Laboratory Supervisor will consult with the referring clinician and/or review all requisitions to confirm testing is being performed appropriately. In certain circumstances (i.e. small family size, families with a significantly biased number of male members) testing may be permitted as an exception to the criteria above. These criteria may change as additional data are obtained which better define the test populations which would benefit from PreOvar® testing).
References:
1.Ratner E, Lu L, Boeke M, et al. A KRAS-variant in Ovarian Cancer Acts as a Genetic Marker of Cancer Risk. Cancer Research 2010; 15: 6509-15.
2.Paranjape T, Heneghan H, Lindner R, et al. A 3'-untranslated region KRAS variant and triple-negative breast cancer: a case-control and genetic analysis. Lancet Oncology 2011.
3.Chin L, Ratner E, Leng S, et al. A SNP in a let-7 microRNA complementary site in the KRAS 3' untranslated region increases non-small cell lung cancer risk. Cancer Res 2008; 68: 8535-40.
4.Smits K, Paranjape T, Nallur S, et al. A let-7 microRNA SNP in the KRAS 3'UTR is prognostic in early-stage colorectal cancer. Clinical Cancer Research 2011; in press.
Not in the PreOvar® KRAS –variant Test Populations are:
1. Women who are cancer free and have families without a history of cancer.
1.Women who have been diagnosed with ovarian cancer (1)* (independent of their BRCA1/BRCA2 mutational status), who:
•May wish to be tested to establish familial patterns of inheritance and aid in estimation of modified ovarian cancer
risk for 1° or 2° relatives
risk for 1° or 2° relatives
Essential patient information: (1) ovarian cancer including type/stage; (2) pedigree if available;
BRCA1/BRCA2 test result if available, i.e. negative, positive - specify mutation or gene variant
2. Women who have been diagnosed with triple negative premenopausal breast cancer (2) (independent of their BRCA1/BRCA2 mutations status), who:
•May wish to be tested to estabilish familial patterns of inheritance and aid in estimation of modified personal ovarian
cancer risk or risk for relatives
cancer risk or risk for relatives
Essential patient information: (1) pedigree if available; (2) breast cancer status including type if available; (3) BRCA1/BRCA2 test result if available, i.e. negative, positive - specify mutation or genetic variant
3. Women considered at high risk for developing ovarian cancer (independent of their cancer status and/or BRCA1/BRCA2 mutational status) because they are 1° or 2° relatives of an affected member of an HBOC family containing any of the following:
•1 ovarian cancer in a 1° or 2° relative (as the patient would be clinically considered at risk despite limited family history)
•1 individual with both breast cancer and ovarian cancer
•3 or more individuals with breast cancer over 3 generations
Essential patient information: (1) pedigree if available; (2) breast cancer status including type if available; (3) BRCA1/BRCA2 test result if available, i.e. negative, positive - specify mutation or genetic variant
*epithelial ovarian/fallopian tube/primary peritoneal
(NOTE: The Laboratory Director and/or Laboratory Supervisor will consult with the referring clinician and/or review all requisitions to confirm testing is being performed appropriately. In certain circumstances (i.e. small family size, families with a significantly biased number of male members) testing may be permitted as an exception to the criteria above. These criteria may change as additional data are obtained which better define the test populations which would benefit from PreOvar® testing).
References:
1.Ratner E, Lu L, Boeke M, et al. A KRAS-variant in Ovarian Cancer Acts as a Genetic Marker of Cancer Risk. Cancer Research 2010; 15: 6509-15.
2.Paranjape T, Heneghan H, Lindner R, et al. A 3'-untranslated region KRAS variant and triple-negative breast cancer: a case-control and genetic analysis. Lancet Oncology 2011.
3.Chin L, Ratner E, Leng S, et al. A SNP in a let-7 microRNA complementary site in the KRAS 3' untranslated region increases non-small cell lung cancer risk. Cancer Res 2008; 68: 8535-40.
4.Smits K, Paranjape T, Nallur S, et al. A let-7 microRNA SNP in the KRAS 3'UTR is prognostic in early-stage colorectal cancer. Clinical Cancer Research 2011; in press.
Not in the PreOvar® KRAS –variant Test Populations are:
1. Women who are cancer free and have families without a history of cancer.