Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006421
Status:
COMPLETED
Last Update Posted:
2024-07-15
First Post:
2000-10-27
Brief Title:
Breast Imaging Studies in Women at High Genetic Risk of Breast Cancer Annual Follow-Up Study
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Breast Imaging Screening Studies in Women at High Genetic Risk of Breast Cancer Annual Follow-up Study
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:
This study will explore new screening methods for early detection of breast and ovarian cancer in women at high risk for these diseases because they have an altered breast cancer 1 BRCA1 or breast cancer 2 BRCA2 gene It will also try to determine if breast tissue characteristics in women with a BRCA1 or BRCA2 mutation differ from those in women with a normal gene
Premenopausal women between 25 and 45 years of age who have participated in National Cancer Institute studies for families or individuals at high genetic risk of cancer 78-C-0039 or 99-C-0081 and who have at least a 50 percent probability of carrying an altered BRCA1 or BRCA2 gene may be eligible for this study
At the first visit participants will have from 4 to 24 tablespoons of blood drawn and will be interviewed about breast and ovarian cancer risk factors family and personal history of cancer history of pregnancies use of oral contraceptives and other hormones and drugs and previous surgery on the breasts and ovaries In addition they will undergo the following procedures
Routine breast and ovarian cancer screening for high-risk women including a mammogram breast and pelvic exam instruction in breast self-examination CA 125 blood test and transvaginal ultrasound of the ovaries
Magnetic Resonance Imaging MRI of the breast MRI uses a strong magnetic field to show structural and chemical changes in tissues
Breast Duct Lavage In this procedure samples of fluid and cells from the lining of the breast milk ducts are collected to look for cancerous or pre-cancerous cell changes
Positron Emission Tomography PET scan PET scanning will be done only in participants whose mammogram or MRI findings require additional evaluation This diagnostic test is based on differences in how cells take up and use glucose sugar one of the body s main fuels
Annual follow-up visits will be scheduled for 3 years and will include routine high-risk screening as described above blood draw update of family history and risk factors breast MRI breast duct lavage and if there are changes on the MRI or mammogram that need further evaluation the PET will be repeated
Premenopausal women between 25 and 45 years of age who have participated in National Cancer Institute studies for families or individuals at high genetic risk of cancer 78-C-0039 or 99-C-0081 and who have at least a 50 percent probability of carrying an altered BRCA1 or BRCA2 gene may be eligible for this study
At the first visit participants will have from 4 to 24 tablespoons of blood drawn and will be interviewed about breast and ovarian cancer risk factors family and personal history of cancer history of pregnancies use of oral contraceptives and other hormones and drugs and previous surgery on the breasts and ovaries In addition they will undergo the following procedures
Routine breast and ovarian cancer screening for high-risk women including a mammogram breast and pelvic exam instruction in breast self-examination CA 125 blood test and transvaginal ultrasound of the ovaries
Magnetic Resonance Imaging MRI of the breast MRI uses a strong magnetic field to show structural and chemical changes in tissues
Breast Duct Lavage In this procedure samples of fluid and cells from the lining of the breast milk ducts are collected to look for cancerous or pre-cancerous cell changes
Positron Emission Tomography PET scan PET scanning will be done only in participants whose mammogram or MRI findings require additional evaluation This diagnostic test is based on differences in how cells take up and use glucose sugar one of the body s main fuels
Annual follow-up visits will be scheduled for 3 years and will include routine high-risk screening as described above blood draw update of family history and risk factors breast MRI breast duct lavage and if there are changes on the MRI or mammogram that need further evaluation the PET will be repeated
Detailed Description:
Background
Women who carry mutations in genes such as BRCA12 have a higher lifetime risk of breast cancer BC and are at risk of developing BC at earlier ages than women in the general population
Prophylactic mastectomy andor oophorectomy may be used to decrease risk and intensified mammographic and magnetic resonance imaging MRI surveillance may allow earlier diagnosis however prophylactic mastectomy has not been shown to convey survival advantage over more conservative management
Greater breast tissue density and low BC incidence result in a lower positive predictive value of mammography in premenopausal women as compared to postmenopausal women PPV004 for women aged 40-49
This study explores whether high-risk breast imaging phenotypes may be identified by comparing imaging characteristics of mutation carriersnon-carriers using two imaging modalities mammography and MRI
Nipple Aspiration Fluid collection NAF and breast duct lavage will be used to obtain cytologic materials which may be used as an adjunct to breast imaging for the early detection of epithelial atypia and pre-invasive cancer
Objectives
Compare four outcomes including two mammographic density measures qualitative and semiquantitative fibroglandular volume measure using MRI and contrast enhancement measure using MRI both semiquantitative in mutation carriersnon-carriers to improve lesion detection
Explore non-ionizing approaches MRI to BC screening because the effects of ionizing radiation due to mammography are unknown
Use NAF andor BDL to obtain epithelial cell samples and correlate cytologic and imaging findings
Gather prospective data on the transformation from normalhyperplasticpre-invasiveinvasive disease in BRCA12 mutation carriersnon-carriers through moleculargenetic studies of breast tissue via biopsy of radiographic abnormalities or breast fluid via BDL andor nipple aspiration and develop molecular markers for early detection of epithelial atypiapre-invasive cancer
Assess the psychosocial impact of participation in a BC screening program
Eligibility
Women 25-56 years of age carrying a known BRCA12 deleterious mutation
Women between the ages of 25 -56 who are first- or second- degree relatives of individuals with a deleterious BRCA12 mutation
Women aged 25-56 who are first- or second- degree relatives of individuals with BRCA-associated cancers in families with documented BRCA mutations
Design
Prospective cohort study of 200 women to gather data on the evolution of epithelial cellmolecular changes in BRCA12 mutation carriers by collectinganalyzing NAF BDL fluid biopsy tissues when indicated and serumlymphocytes samples are stored for future studies
Women complete questionnaires and undergo breastpelvis examination transvaginal ultrasonography serum pregnancy test fasting glucose electrolytes BUN creatinine and CA 125 Standard four view mammogram and breast MRI are performed on study entry and annually for three additional years
Women who carry mutations in genes such as BRCA12 have a higher lifetime risk of breast cancer BC and are at risk of developing BC at earlier ages than women in the general population
Prophylactic mastectomy andor oophorectomy may be used to decrease risk and intensified mammographic and magnetic resonance imaging MRI surveillance may allow earlier diagnosis however prophylactic mastectomy has not been shown to convey survival advantage over more conservative management
Greater breast tissue density and low BC incidence result in a lower positive predictive value of mammography in premenopausal women as compared to postmenopausal women PPV004 for women aged 40-49
This study explores whether high-risk breast imaging phenotypes may be identified by comparing imaging characteristics of mutation carriersnon-carriers using two imaging modalities mammography and MRI
Nipple Aspiration Fluid collection NAF and breast duct lavage will be used to obtain cytologic materials which may be used as an adjunct to breast imaging for the early detection of epithelial atypia and pre-invasive cancer
Objectives
Compare four outcomes including two mammographic density measures qualitative and semiquantitative fibroglandular volume measure using MRI and contrast enhancement measure using MRI both semiquantitative in mutation carriersnon-carriers to improve lesion detection
Explore non-ionizing approaches MRI to BC screening because the effects of ionizing radiation due to mammography are unknown
Use NAF andor BDL to obtain epithelial cell samples and correlate cytologic and imaging findings
Gather prospective data on the transformation from normalhyperplasticpre-invasiveinvasive disease in BRCA12 mutation carriersnon-carriers through moleculargenetic studies of breast tissue via biopsy of radiographic abnormalities or breast fluid via BDL andor nipple aspiration and develop molecular markers for early detection of epithelial atypiapre-invasive cancer
Assess the psychosocial impact of participation in a BC screening program
Eligibility
Women 25-56 years of age carrying a known BRCA12 deleterious mutation
Women between the ages of 25 -56 who are first- or second- degree relatives of individuals with a deleterious BRCA12 mutation
Women aged 25-56 who are first- or second- degree relatives of individuals with BRCA-associated cancers in families with documented BRCA mutations
Design
Prospective cohort study of 200 women to gather data on the evolution of epithelial cellmolecular changes in BRCA12 mutation carriers by collectinganalyzing NAF BDL fluid biopsy tissues when indicated and serumlymphocytes samples are stored for future studies
Women complete questionnaires and undergo breastpelvis examination transvaginal ultrasonography serum pregnancy test fasting glucose electrolytes BUN creatinine and CA 125 Standard four view mammogram and breast MRI are performed on study entry and annually for three additional years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| 01-C-0009 | None | None | None |