Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00043472
Status:
COMPLETED
Last Update Posted:
2024-07-15
First Post:
2006-06-19
Brief Title:
Removal of the OvariesFallopian Tubes and CA-125 Screening to Reduce the Risk of Ovarian Cancer in Women at Increased Genetic Risk
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Prospective Study of Prophylactic Salpingo-Oophorectomy and Longitudinal CA-125 Screening Among Women at Increased Genetic Risk of Ovarian Cancer
Status:
COMPLETED
Status Verified Date:
2024-06-12
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:
This study will evaluate women who are at increased genetic risk of developing ovarian cancer because they or a close relative have a mutation in the BRCA1 or BRCA2 gene the genes that cause most of the genetic forms of ovarian cancer or because they have a very strong family history of breast andor ovarian cancer The study has two aspects There will be two groups of subjects in this study One group of women who will have their ovaries and fallopian tubes surgically removed as a prophylactic preventive measure against developing ovarianfallopian tube cancer These women will be studied to determine whether the surgery does in fact decrease the risk of ovarian or tubal cancer and whether it decreases the risk of breast and other cancers The tissue removed at surgery will also be investigated to see whether a new way of examining the ovaries after they are removed provides better information about cancer-related tissue changes A second group of subjects will be women who choose not to have preventive surgery These women will be followed closely to see if screening with multiple CA-125 blood testing over time see below can detect ovarian or tubal cancers in their early stages Both groups of women will undergo examination of the process by which women decide upon various options for lowering their ovarian cancer risk and a detailed assessment of how their choice impacts their quality of life It will look at how those who opt for ovariectomy feel after their surgery and how those who choose screening feel during the time of screening
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 ovarianfallopian 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 httpwwwgogorg
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 ovarianfallopian 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 httpwwwgogorg
Detailed Description:
Background
Annually more than 25500 women develop ovarian cancer OC and more than 16000 die of this disease in the United States
Women at high genetic risk of OC have a much higher lifetime risk of developing OC than women in the general population
OC is difficult to detect using current screening methods which include CA-125 monitoring and transvaginal ultrasound TVUS most women are diagnosed when the disease is in advanced stage when survival chances are low
This protocol investigates a novel OC screening strategy longitudinal CA-125 levels using a mathematical algorithm known as ROCA and TVUS and surgical methods risk-reducing salpingo-oophorectomy RRSO in managing women at high genetic risk of OC
Objectives
To pool resources from intramural and extramural OC investigators and obtain the first prospective data from high-risk women addressing the incidence of critical cancer endpoints and quality of life thus determining
1 by how much RRSO reduces OCBreast Cancer BC risk
2 how RRSO affects quality of life
3 which factors influence the decision about which management approach to choose
4 how premature menopause affects the risk of developing medical problems
5 if there are detectable abnormalities in ovaries which allow for early diagnosis and
6 how cellularmolecular malignant processes occur
Eligibility
Women age 30 or older with no prior history of OC and at least one intact ovary
Must be at increased genetic risk of OC by meeting one of the following criteria
1 Subject or close blood relative has tested positive for a BRCA12 mutation or
2 Subject has family history of 2 or more close blood relatives with BC andor OC or
3 Subject has family history of 1 or more close blood relatives with BC andor OC and Ashkenazi Jewish ancestry or
4 Subject has had premenopausal BC and is of Ashkenazi Jewish descent or
5 Subject has estimated probability of having a BRCA12 mutation using BRCAPRO evaluation
If the presence of BC is used for eligibility at least one BC must be of premenopausal onset If menopausal status at the time of BC diagnosis is unknown age at diagnosis must be less than 50 years
Design
International multi-institution prospective cohort collaborative study between NCIs Clinical Genetics Branch Gynecologic Oncology Group GOG and Cancer Genetics Network
Two-arm non-randomized study of women contemplating RRSO to diminish their OC risk
Women decide whether to undergo RRSO in consultation with their physicians
1 Women who choose RRSO have surgery under a standardized procedure Clinically occult primary cancers and precursor lesions are sought and material is banked for molecular studies CA-125 levels are measured twice yearly
2 Women who decline RRSO choose OC screening with quarterly CA125ROCA which provides estimates of the likelihood that subjects have OC TVUS and gynecologic oncology consultation may be arranged TVUS is done on an annual basis at minimum
Subjects from both arms complete demographic epidemiologic and psychosocial instruments and provide blood samples for research-based genetic testing germline BRCA12 CA-125 testing and serumplasmaDNA storage
Primary outcomes are development of OC fallopian tube cancer primary peritoneal carcinoma and BC
Study accrual goals include approximately 800 subjects in the RRSO arm and 2400 subjects in the screening arm each to include at least 400 BRCA12 mutation carriers
Annually more than 25500 women develop ovarian cancer OC and more than 16000 die of this disease in the United States
Women at high genetic risk of OC have a much higher lifetime risk of developing OC than women in the general population
OC is difficult to detect using current screening methods which include CA-125 monitoring and transvaginal ultrasound TVUS most women are diagnosed when the disease is in advanced stage when survival chances are low
This protocol investigates a novel OC screening strategy longitudinal CA-125 levels using a mathematical algorithm known as ROCA and TVUS and surgical methods risk-reducing salpingo-oophorectomy RRSO in managing women at high genetic risk of OC
Objectives
To pool resources from intramural and extramural OC investigators and obtain the first prospective data from high-risk women addressing the incidence of critical cancer endpoints and quality of life thus determining
1 by how much RRSO reduces OCBreast Cancer BC risk
2 how RRSO affects quality of life
3 which factors influence the decision about which management approach to choose
4 how premature menopause affects the risk of developing medical problems
5 if there are detectable abnormalities in ovaries which allow for early diagnosis and
6 how cellularmolecular malignant processes occur
Eligibility
Women age 30 or older with no prior history of OC and at least one intact ovary
Must be at increased genetic risk of OC by meeting one of the following criteria
1 Subject or close blood relative has tested positive for a BRCA12 mutation or
2 Subject has family history of 2 or more close blood relatives with BC andor OC or
3 Subject has family history of 1 or more close blood relatives with BC andor OC and Ashkenazi Jewish ancestry or
4 Subject has had premenopausal BC and is of Ashkenazi Jewish descent or
5 Subject has estimated probability of having a BRCA12 mutation using BRCAPRO evaluation
If the presence of BC is used for eligibility at least one BC must be of premenopausal onset If menopausal status at the time of BC diagnosis is unknown age at diagnosis must be less than 50 years
Design
International multi-institution prospective cohort collaborative study between NCIs Clinical Genetics Branch Gynecologic Oncology Group GOG and Cancer Genetics Network
Two-arm non-randomized study of women contemplating RRSO to diminish their OC risk
Women decide whether to undergo RRSO in consultation with their physicians
1 Women who choose RRSO have surgery under a standardized procedure Clinically occult primary cancers and precursor lesions are sought and material is banked for molecular studies CA-125 levels are measured twice yearly
2 Women who decline RRSO choose OC screening with quarterly CA125ROCA which provides estimates of the likelihood that subjects have OC TVUS and gynecologic oncology consultation may be arranged TVUS is done on an annual basis at minimum
Subjects from both arms complete demographic epidemiologic and psychosocial instruments and provide blood samples for research-based genetic testing germline BRCA12 CA-125 testing and serumplasmaDNA storage
Primary outcomes are development of OC fallopian tube cancer primary peritoneal carcinoma and BC
Study accrual goals include approximately 800 subjects in the RRSO arm and 2400 subjects in the screening arm each to include at least 400 BRCA12 mutation carriers
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-0268 | None | None | None |