Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006425
Status:
COMPLETED
Last Update Posted:
2020-11-27
First Post:
2000-10-31
Brief Title:
Breast Imaging Studies in Women at High Genetic Risk of Breast Cancer Menstrual Cycle Study
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Breast Imaging Studies in Women at High Genetic Risk of Breast Cancer Menstrual Cycle Pilot Study
Status:
COMPLETED
Status Verified Date:
2020-11
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:
Women who carrying a BRCA1 or BRCA2 gene mutation or who are the first- or second-degree relative of an individual with a BRCA-associated cancer in a family documented to have a BRCA1 or BRCA2 mutation will be eligible for enrollment into this pilot study of breast cancer screening modalities We will recruit up to fifty women twenty-five women who carry an altered BRCA1 or BRCA2 gene and 25 non-carriers matched by age and family mutation type with regular menstrual cycling documented by menstrual history and premenopausal FSH level A physical exam including exam of the breast and pelvis a standard four view mammogram breast MRI and PET scan will be scheduled initially during either the follicular or mid-luteal phase of the menstrual cycle A unilateral cranio-caudal mammogram and bilateral MRI and PET scan will be repeated three months after entry during the phase not initially studied A CA125 and transvaginal color doppler ultrasonography will be done in the follicular phase Carriers and non-carriers will be compared with respect to menstrual cycle differences in 1 two measures of mammographic density qualitative and semiquantitative 2 a semiquantitative measure of fibroglandular volume MRI 3 a semiquantitative measure of contrast enhancement MRI and 4 FDG uptake measured over time PET scan On the initial and three-month visit all participants will undergo breast duct lavage to investigate if there are consistent menstrual cycle differences in breast ductal cytologies Participants will be seen annually thereafter for an additional three years of follow-up A physical exam standard four-view mammography breast MRI CA 125 transvaginal color doppler ultrasonography and breast duct lavage will be done annually Consent for a PET study will be requested if an abnormality is detected on mammography or breast MRI requiring additional clinical or radiographic follow-up
Participants in the Menstrual Cycle Pilot Study will complete a self-administered questionnaire and telephone interview and will complete periodic follow-up questionnaires to assess various behavioral and psychosocial endpoints
As part of the Menstrual Cycle Pilot Study we will recruit 25 volunteers to assist in training study investigators in performing breast duct lavage Cytologies obtained from volunteers will be used to develop oncogene probe panels to be used in the study
Participants in the Menstrual Cycle Pilot Study will complete a self-administered questionnaire and telephone interview and will complete periodic follow-up questionnaires to assess various behavioral and psychosocial endpoints
As part of the Menstrual Cycle Pilot Study we will recruit 25 volunteers to assist in training study investigators in performing breast duct lavage Cytologies obtained from volunteers will be used to develop oncogene probe panels to be used in the study
Detailed Description:
Asymptomatic premenopausal women are 1 known carriers of an altered BRCA1 or BRCA2 gene or 2 first- or second-degree relatives of individuals with a BRCA-associated cancer in a family documented to have a BRCA1 or BRCA2 gene mutation will be eligible for inclusion in this pilot study to assess new approaches to early detection of breast and ovarian cancer in high-risk women We will recruit up to fifty women twenty-five women who carry an altered BRCA1 or BRCA2 gene and 25 non-carriers matched by age and family mutation type with regular menstrual cycling documented by menstrual history and premenopausal FSH level A physical exam including exam of the breast and pelvis a standard four view mammogram and breast MRI will be scheduled initially during either the follicular or mid-luteal phase of the menstrual cycle A unilateral cranio-caudal mammogram and bilateral MRI will be repeated three months after entry during the phase not initially studied A CA125 and transvaginal color doppler ultrasonography will be done in the follicular phase Carriers and non-carriers will be compared with respect to menstrual cycle differences in 1 two measures of mammographic density qualitative and semiquantitative 2 a semiquantitative measure of fibroglandular volume MRI and 3 a semiquantitative measure of contrast enhancement MRI On the initial and three-month visit all participants will undergo breast duct lavage to investigate if there are consistent menstrual cycle differences in breast ductal cytologies Participants will be seen annually thereafter for an additional three years of follow-up A physical exam standard four-view mammography breast MRI CA 125 transvaginal color doppler ultrasonography and breast duct lavage will be done annually
Participants in the Menstrual Cycle Pilot Study will complete a self-administered questionnaire and telephone interview and will complete periodic follow-up questionnaires to assess various behavioral and psychosocial endpoints
As part of the Menstrual Cycle Pilot Study we will recruit 25 volunteers to assist in training study investigators in performing breast duct lavage Cytologies obtained from volunteers will be used to develop oncogene probe panels to be used in the study
Participants in the Menstrual Cycle Pilot Study will complete a self-administered questionnaire and telephone interview and will complete periodic follow-up questionnaires to assess various behavioral and psychosocial endpoints
As part of the Menstrual Cycle Pilot Study we will recruit 25 volunteers to assist in training study investigators in performing breast duct lavage Cytologies obtained from volunteers will be used to develop oncogene probe panels to be used in the study
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-0008 | None | None | None |