Breast CancerNCT00006425
Breast Imaging Studies in Women at High Genetic Risk of Breast Cancer: Menstrual Cycle Study
An observational study of Breast Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Dec 2000to 3 Oct 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: As part of the Menstrual Cycle Pilot Study, we recruited 25 volunteers to assist in training study investigators in performing breast duct lavage. Cytologies obtained from volunteers were used to develop expertise in interpretation and management of women undergoing ductal lavage.
Who may be able to join
- To participate in the Menstrual Cycle Pilot Study, a woman must:
- Must be at least 25 years of age (or 5 years younger than the age at diagnosis of the youngest family member with a tumor associated with the Breast-Ovarian Cancer Syndrome) and less than 46 years of age.
- Must be premenopausal as determined by menstrual history (no change in menstrual pattern in prior 6 months) and an FSH level less than 15 mIU/ml obtained on the third day of the menstrual cycle.
- Have undergone genetic counseling and risk assessment.
- Must be a known mutation carrier or be a first- or second-degree relative of an individual with a tumor associated with the Breast-Ovarian Cancer Syndrome in a family with a known BRCA mutation.
- Agree to release of genetic test result for stratification purposes, whether or not she has chosen to receive individual test results for clinical decision-making.
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- Be willing to use non-hormonal methods of contraception until completion of the 3 month follow-up studies.
- Have an ECOG performance status of 0-1.
- Be able to provide informed consent.
- To participate in the Training Cohort a volunteer must:
- Be female and at least 18 years and less than 51 years of age.
- Have at least one breast considered eligible for study.
- Provide evidence (either films or radiologist's report) of a mammogram done within the 12 months prior to enrollment showing low or no suspicion of carcinoma in at least one breast. (Mammograms will not be provided to participants as part of the training cohort.)
- Have a physical examination of the breast to be studied consistent with low or no suspicion of carcinoma at the time of enrollment.
- Provide the name of a primary care physician to whom the results of breast duct lavage cytologies can be sent.
- Have signed the informed consent for breast duct lavage.
Who cannot join
- Any of the following will result in exclusion from the Menstrual Cycle Pilot Study:
- A history of menstrual cycle irregularities over the previous 6 months, including history of cycles less than 26 days or more than 35 days.
- Steroid therapy, use of selective estrogen receptor modulators (SERMs) or hormonal agents (including tamoxifen, raloxifene, estrogen, DHEA, anabolic steroids, oral contraceptives, depoprovera, progestin IUD, oral progestins, norplant, or drugs to induce ovulation) within 6 months prior to study entry and must agree not to use these compounds until completion of the three-month follow-up study.
- Pregnancy or lactation within 12 months of enrollment.
- History of infertility with a suspected ovarian etiology or persistent ovarian cyst.
- Abnormal CA-125 level.
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- History of invasive cancer except for non-melanoma skin cancer or cervical carcinoma in situ.
- Creatinine greater than 2.
- Previous bilateral mastectomy, bilateral radiation therapy to the breast, or oophorectomy.
- History of DCIS or LCIS .
- Weight over 136 kilograms.
- Allergy to gadolinium.
- Allergy to lidocaine or Marcaine (bupivacaine) (excluded from breast duct lavage only).
- Medical or psychiatric disorder which, in the opinion of the Principal Investigator, would preclude informed consent or ability to participate in clinical research.
- Any of the following will exclude a potential participant from the Training Cohort:
- Pregnancy or lactation within the past 12 prior to enrollment.
- Subareolar or other surgery of the breast to be studied (papilloma resection, biopsy or fine needle aspirations which might disrupt the ductal systems within 2 cm of the nipple. (Biopsies of fine needle aspirations of the breast greater than or equal to 2 cm from the nipple are acceptable.)
- A breast implant or prior silicone injections in the breast to be studied.
- Radiation therapy to a breast to be studied.
- Active infections or inflammation in a breast to be studied.
- Chemotherapy or a selective estrogen receptor modifier (e.g., tamoxifen or raloxifen) taken within 12 months prior to enrollment.
- A known allergy to lidocaine, prilocaine or Marcaine (bupivacaine).
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Breast Imaging Studies in Women at High Genetic Risk of Breast Cancer: Menstrual Cycle Pilot Study
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.
Read the 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.
- Conditions
- Breast Cancer
- Keywords
- Breast MRI, Ductal lavage, Nipple Aspirate Fluid, Transvaginal ultrasound
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | 25 women undergoing ductal lavage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the effect of menstrual cycle phase on five breast imaging outcome measures.
These are: 2 measures of mammographic density (qualitative and semiquantitative), a semiquantitative measure of fibroglandular volume and of dynamic contrast enhancement (MRI), and FDG uptake over time (PET scan). We will determine if these measures vary between the carriers \& non carriers of BRCA1/2 mutations.Due to the difficulty in tracking and timing menstrual cycles in women who resided great distances from the NIH, we abandoned further recruitment after the pilot study of ductal lavage.
Measured: Duration of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2000 (estimated)
- Study start19 Dec 2000
- Primary completion31 Dec 2005
- Study completion3 Oct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Jennifer T Loud, C.R.N.P., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006425
- Sponsor's protocol ID
- 010008
- Other IDs
- 01-C-0008
- Status last verified
- Nov 2020
- First submitted
- 31 Oct 2000
- Last updated
- 27 Nov 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Imaging Studies in Women at High Genetic Risk of Breast Cancer: Menstrual Cycle Pilot Study
- ClinicalTrials.gov ID
- NCT00006425
- Acronym / sponsor ID
- 010008
- Conditions
- Breast Cancer
- Keywords
- Breast MRI, Ductal lavage, Nipple Aspirate Fluid, Transvaginal ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 19 Dec 2000 (actual)
- Primary completion
- 31 Dec 2005 (actual)
- Study completion
- 3 Oct 2008 (actual)
- First posted
- 1 Nov 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –25 women undergoing ductal lavage |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- As part of the Menstrual Cycle Pilot Study, we recruited 25 volunteers to assist in training study investigators in performing breast duct lavage. Cytologies obtained from volunteers were used to develop expertise in interpretation and management of women undergoing ductal lavage.
Key inclusion criteria (16 listed)
- Must be at least 25 years of age (or 5 years younger than the age at diagnosis of the youngest family member with a tumor associated with the Breast-Ovarian Cancer Syndrome) and less than 46 years of age.
- Must be premenopausal as determined by menstrual history (no change in menstrual pattern in prior 6 months) and an FSH level less than 15 mIU/ml obtained on the third day of the menstrual cycle.
- Have undergone genetic counseling and risk assessment.
- Must be a known mutation carrier or be a first- or second-degree relative of an individual with a tumor associated with the Breast-Ovarian Cancer Syndrome in a family with a known BRCA mutation.
- Agree to release of genetic test result for stratification purposes, whether or not she has chosen to receive individual test results for clinical decision-making.
Key exclusion criteria (22 listed)
- A history of menstrual cycle irregularities over the previous 6 months, including history of cycles less than 26 days or more than 35 days.
- Steroid therapy, use of selective estrogen receptor modulators (SERMs) or hormonal agents (including tamoxifen, raloxifene, estrogen, DHEA, anabolic steroids, oral contraceptives, depoprovera, progestin IUD, oral progestins, norplant, or drugs to induce ovulation) within 6 months prior to study entry and must agree not to use these compounds until completion of the three-month follow-up study.
- Pregnancy or lactation within 12 months of enrollment.
- History of infertility with a suspected ovarian etiology or persistent ovarian cyst.
- Abnormal CA-125 level.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determine the effect of menstrual cycle phase on five breast imaging outcome measures.
Time frame: Duration of study
These are: 2 measures of mammographic density (qualitative and semiquantitative), a semiquantitative measure of fibroglandular volume and of dynamic contrast enhancement (MRI), and FDG uptake over time (PET scan). We will determine if these measures vary between the carriers \& non carriers of BRCA1/2 mutations.Due to the difficulty in tracking and timing menstrual cycles in women who resided great distances from the NIH, we abandoned further recruitment after the pilot study of ductal lavage.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2020.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer T Loud, C.R.N.P. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the effect of menstrual cycle phase on five breast imaging outcome measures. (time frame: Duration of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2020.