This study is NOT currently recruiting participants.
Number
02-C-0268
Sponsoring Institute
National Cancer Institute (NCI)
Recruitment Detail
Type: Completed Study; data analyses ongoing Gender: Female Min Age: 19 Max Age: 100
Referral Letter Required
No
Population Exclusion(s)
Male;Children
Keywords
Screening; Oophorectomy; Hereditary; Genetics; Cancer
Recruitment Keyword(s)
None
Condition(s)
Breast Cancer; Ovarian Cancer
Investigational Drug(s)
Investigational Device(s)
Intervention(s)
Supporting Site
National Cancer Institute
All participants will undergo the following procedures:
- Medical history, physical examination, and blood drawing upon entering the study, including blood samples for future ovarian cancer research.
- Screening mammogram, CA-125 blood test, and transvaginal ultrasound upon entering the study, with yearly repeat mammograms for all participants and yearly transvaginal ultrasound exams for women in the screening arm of the study. CA-125 is a protein found in the blood whose levels are elevated in most women with ovarian cancer. Transvaginal ultrasound is a way of taking pictures of the ovaries using sound waves. If the results of these tests are not normal, additional tests may be required to learn the reason for the abnormality.
- Questionnaires about personal, medical and family history, ovarian cancer risk factors, medication use, medical choices, and quality of life on entering the study, with repeat quality of life and medication use questionnaires every 6 months during the study period.
- Blood samples for follow-up visits and for CA-125 testing every 3 months as a screen for ovarian/fallopian tube cancers. Some blood from these samples will be saved for future ovarian cancer research.
- Semi-annual report during the duration of the study regarding health and quality of life changes that occur over the prior 6-month period.
Researchers will use the pattern and rate of change of CA-125 levels over time in women in the screening group to decide if more tests are needed to test for ovarian cancer. Women in the surgery portion will undergo surgical removal of their ovaries and fallopian tubes. The removed tissues will be studied using new methods to examine the cells more closely than usual, and a portion of the tissues will be stored for future research on ovarian cancer. This study is being conducted in collaboration with the Gynecologic Oncology Group (GOG), and is designated GOG Protocol 0199. Subjects may join the study at any participating GOG institution (http://www.gog.org).
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INCLUSION CRITERIA: To be considered at increased genetic risk of OC, subjects must have: Age greater than or equal to 30; No prior history of OC, including low malignant potential cancers (LMP), or primary papillary serous carcinoma of the peritoneum; At least one intact ovary: Satisfied one of the following additional criteria: The family of the subject has a documented deleterious BRCA1 or BRCA2 mutation - either: - the subject herself has tested positive for a deleterious BRCA1 or BRCA2 mutation; OR -the subject has a first- or second-degree relative with a deleterious BRCA1 or BRCA2 mutation OR The family contains at least two ovarian and/or breast cancers among the subject or first- or second-degree relatives of the subject within the same lineage. This condition is satisfied by multiple primary cancers in the same person. Where breast cancer is required to meet this criterion, at least one breast cancer must have been diagnosed prior to menopause (age at diagnosis less than or equal to 50 if age at menopause is unknown); OR The subject is of Ashkenazi Jewish ethnicity with one first-degree or two second-degree relatives with breast and/or OC. Where breast cancer is required to meet this criterion, at least one case must have been diagnosed prior to menopause (or at age less than or equal to 50, if age at menopause is unknown). OR The subject is of Ashkenazi ancestry and has had breast cancer herself. To meet this criterion, her breast cancer must have been diagnosed prior to menopause (age at diagnosis less than or equal to 50 if age at menopause is unknown). OR The probability of carrying a BRCA1/2 mutation given the family pedigree of breast and OCs exceeds 20% as calculated by BRCAPRO. Note: BRCAPRO does NOT need to be calculated on everyone who enters the study. Patients are eligible based on a family history which meets one of the specific patterns described in this protocol, regardless of BRCAPRO results. BRCAPRO assessment is valuable in families where genetic testing has not been done, and the family history does not fit one of the specific patterns described, but the pattern of cancers leads you to believe that the family might still be considered high-risk. At that point, if the BRCAPRO estimate of being a mutation carrier is greater than 20 percent, then the patient IS eligible. Signed an approved informed consent and authorization permitting release of personal health information. EXCLUSION CRITERIA: A first- or second-degree relative has a deleterious BRCA1/2 mutation, and the subject has tested NEGATIVE for the exact same mutation. Women who are currently pregnant or planning pregnancy during the study. Women who are participating in another OC early detection trial (except for the ROCA study being run by the Cancer Genetics Network. Women who have enrolled in the ROCA study and who subsequently choose to undergo surgery may enroll in the surgical cohort of GOG 0199). Women with psychiatric, psychological or other conditions which prevent fully informed consent. Women with current untreated malignancy (excluding non-melanoma skin cancer). Women with adjuvant radiation therapy or chemotherapy within the past 1 month (31 days). For purposes of this study, any biologic agent administered with an anti-cancer therapeutic intent (e.g., Herceptin) will also not be permitted. Women who have been treated for prior metastatic malignant disease within the past 5 years. Women who have undergone intraperitoneal surgery within the prior 3 months (includes laparoscopy). Women who have had both ovaries removed prior to study entry. Women with a history of any medical condition which places the subject at risk related to the need for donating blood for research purposes, e.g., chronic infectious diseases, severe anemia, hemophilia. Note: Enrollment of women in whom there is a significant pre-operative clinical suspicion that there might exist ovarian or fallopian tube caner should be avoided. The intent of the study is to ascertain subjects who are contemplating a risk-reducing, rather than a therapeutic, procedure. Women with findings of uncertain significant on baseline TVUS remain eligible.
To be considered at increased genetic risk of OC, subjects must have:
Age greater than or equal to 30;
No prior history of OC, including low malignant potential cancers (LMP), or primary papillary serous carcinoma of the peritoneum;
At least one intact ovary:
Satisfied one of the following additional criteria:
The family of the subject has a documented deleterious BRCA1 or BRCA2 mutation - either:
- the subject herself has tested positive for a deleterious BRCA1 or BRCA2 mutation; OR
-the subject has a first- or second-degree relative with a deleterious BRCA1 or BRCA2 mutation
OR
The family contains at least two ovarian and/or breast cancers among the subject or first- or second-degree relatives of the subject within the same lineage. This condition is satisfied by multiple primary cancers in the same person. Where breast cancer is required to meet this criterion, at least one breast cancer must have been diagnosed prior to menopause (age at diagnosis less than or equal to 50 if age at menopause is unknown); OR
The subject is of Ashkenazi Jewish ethnicity with one first-degree or two second-degree relatives with breast and/or OC. Where breast cancer is required to meet this criterion, at least one case must have been diagnosed prior to menopause (or at age less than or equal to 50, if age at menopause is unknown).
The subject is of Ashkenazi ancestry and has had breast cancer herself. To meet this criterion, her breast cancer must have been diagnosed prior to menopause (age at diagnosis less than or equal to 50 if age at menopause is unknown).
The probability of carrying a BRCA1/2 mutation given the family pedigree of breast and OCs exceeds 20% as calculated by BRCAPRO.
Note: BRCAPRO does NOT need to be calculated on everyone who enters the study. Patients are eligible based on a family history which meets one of the specific patterns described in this protocol, regardless of BRCAPRO results. BRCAPRO assessment is valuable in families where genetic testing has not been done, and the family history does not fit one of the specific patterns described, but the pattern of cancers leads you to believe that the family might still be considered high-risk. At that point, if the BRCAPRO estimate of being a mutation carrier is greater than 20 percent, then the patient IS eligible.
Signed an approved informed consent and authorization permitting release of personal health information.
EXCLUSION CRITERIA:
A first- or second-degree relative has a deleterious BRCA1/2 mutation, and the subject has tested NEGATIVE for the exact same mutation.
Women who are currently pregnant or planning pregnancy during the study.
Women who are participating in another OC early detection trial (except for the ROCA study being run by the Cancer Genetics Network. Women who have enrolled in the ROCA study and who subsequently choose to undergo surgery may enroll in the surgical cohort of GOG 0199).
Women with psychiatric, psychological or other conditions which prevent fully informed consent.
Women with current untreated malignancy (excluding non-melanoma skin cancer).
Women with adjuvant radiation therapy or chemotherapy within the past 1 month (31 days). For purposes of this study, any biologic agent administered with an anti-cancer therapeutic intent (e.g., Herceptin) will also not be permitted.
Women who have been treated for prior metastatic malignant disease within the past 5 years.
Women who have undergone intraperitoneal surgery within the prior 3 months (includes laparoscopy).
Women who have had both ovaries removed prior to study entry.
Women with a history of any medical condition which places the subject at risk related to the need for donating blood for research purposes, e.g., chronic infectious diseases, severe anemia, hemophilia.
Note: Enrollment of women in whom there is a significant pre-operative clinical suspicion that there might exist ovarian or fallopian tube caner should be avoided. The intent of the study is to ascertain subjects who are contemplating a risk-reducing, rather than a therapeutic, procedure. Women with findings of uncertain significant on baseline TVUS remain eligible.
Principal Investigator
Referral Contact
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