Cancer Free WomenNCT01649661
MRI Parenchymal Enhancement: A New Marker of Breast Cancer Risk
An observational study of Cancer Free Women, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to learn about how a woman's health history influences what a normal breast looks like on an MRI. The investigators also want to learn about how the amount of different natural hormones a woman has affects how the breast looks on an MRI. Read more about this study
- Who is it for?
- Ages 21 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cancer Free Women
- What is being tested?
- questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 437 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to 25 Jan 2023
- 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 21 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: The proposed study will involve cancer-free women who are undergoing breast MRI screening at MSKCC.
Who may be able to join
- age 21 years or older
- be a cancer-free pre- or postmenopausal woman
- have no prior personal history of any cancer (including DCIS, excluding nonmelanoma skin-cancer)
- able to speak and read English because the questionnaire is only available in English
- able to provide informed consent
Who cannot join
- are pregnant at the time of MRI
- have a prior personal history of any cancer (including DCIS, excluding nonmelanoma skin cancer)
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10021
About this study
Official title: Epidemiology of MRI Parenchymal Enhancement: A New Marker of Breast Cancer Risk
The purpose of this study is to learn about how a woman's health history influences what a normal breast looks like on an MRI. The investigators also want to learn about how the amount of different natural hormones a woman has affects how the breast looks on an MRI. The investigator's hope is that this will help to find women at a high-risk of breast cancer.
- Conditions
- Cancer Free Women
- Being tested
- questionnaire
- Keywords
- MRI, 12-125, premenopausal women, postmenopausal women, questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireBehavioural
Also called The study questionnaire is a 15-20 minute survey at or shortly after the time of MRI consisting of 27, questions in 7 domains:background information (e.g., date of birth, country of birth, race/ethnicity), medical, history, family history of cancer, reproductive history, use of hormonal medications, alcohol and, smoking, contact information/comments.
| Study group | Role | What they receive |
|---|---|---|
| premenopausal women | Only women already scheduled for a breast MRI will be included in the study, no additional MRIs will be scheduled for study purposes. Receives: Behavioral: questionnaire | |
| postmenopausal women | Only women already scheduled for a breast MRI will be included in the study, no additional MRIs will be scheduled for study purposes. Receives: Behavioral: questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
breast cancer risk factors and background parenchymal enhancement (BPE).
A comparison of the distribution of breast cancer risk factors in women with low and high levels of BPE. The relationship between risk factors and categories of BPE (minimal/mild/moderate/marked) will be determined using ordinal logistic regression.
Measured: 1 year
Secondary outcomes (1)
relationship between BPE and serum hormone levels at the time of MRI
Determine the relationship between serum hormone levels (testosterone, estradiol (E2), estrone (E1), androstenedione (A4) and sex hormone binding globulin (SHBG)) at the time of MRI and degree of BPE in healthy high-risk postmenopausal women. The association between circulating serum hormone levels and BPE will be determined using linear regression.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2012 (estimated)
- Study startJul 2012
- Primary completion25 Jan 2023
- Study completion25 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer Free WomenStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 437 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), University of Southern California, University of Toronto
- Responsible party
- Sponsor
- Investigators
- Janice Sung, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01649661
- Sponsor's protocol ID
- 12-125
- Status last verified
- Jan 2023
- First submitted
- 19 Jul 2012
- Last updated
- 26 Jan 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of MRI Parenchymal Enhancement: A New Marker of Breast Cancer Risk
- ClinicalTrials.gov ID
- NCT01649661
- Acronym / sponsor ID
- 12-125
- Conditions
- Cancer Free Women
- Keywords
- MRI, 12-125, premenopausal women, postmenopausal women, questionnaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 437 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), University of Southern California, University of Toronto
- Study start
- Jul 2012
- Primary completion
- 25 Jan 2023 (actual)
- Study completion
- 25 Jan 2023 (actual)
- First posted
- 25 Jul 2012 (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.
The purpose of this study is to learn about how a woman's health history influences what a normal breast looks like on an MRI. The investigators also want to learn about how the amount of different natural hormones a woman has affects how the breast looks on an MRI. The investigator's hope is that this will help to find women at a high-risk of breast cancer.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| premenopausal women | – | Behavioral: questionnaireOnly women already scheduled for a breast MRI will be included in the study, no additional MRIs will be scheduled for study purposes. |
| postmenopausal women | – | Behavioral: questionnaireOnly women already scheduled for a breast MRI will be included in the study, no additional MRIs will be scheduled for study purposes. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The proposed study will involve cancer-free women who are undergoing breast MRI screening at MSKCC.
Key inclusion criteria (5 listed)
- age 21 years or older
- be a cancer-free pre- or postmenopausal woman
- have no prior personal history of any cancer (including DCIS, excluding nonmelanoma skin-cancer)
- able to speak and read English because the questionnaire is only available in English
- able to provide informed consent
Key exclusion criteria (2 listed)
- are pregnant at the time of MRI
- have a prior personal history of any cancer (including DCIS, excluding nonmelanoma skin cancer)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaireAlso: The study questionnaire is a 15-20 minute survey at or shortly after the time of MRI consisting of 27, questions in 7 domains:background information (e.g., date of birth, country of birth, race/ethnicity), medical, history, family history of cancer, reproductive history, use of hormonal medications, alcohol and, smoking, contact information/comments. | Behavioural | postmenopausal women, premenopausal women |
Primary outcome
breast cancer risk factors and background parenchymal enhancement (BPE).
Time frame: 1 year
A comparison of the distribution of breast cancer risk factors in women with low and high levels of BPE. The relationship between risk factors and categories of BPE (minimal/mild/moderate/marked) will be determined using ordinal logistic regression.
1 secondary outcome
relationship between BPE and serum hormone levels at the time of MRI
Time frame: 1 year
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 26 Jan 2023.
- Memorial Sloan Kettering Cancer CenterLink 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.
Janice Sung, MD principal investigator
Memorial Sloan Kettering Cancer Center
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 Cancer Free Women, run by Memorial Sloan Kettering Cancer Center 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 5 inclusion and 2 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 26 Jan 2023. 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?
breast cancer risk factors and background parenchymal enhancement (BPE). (time frame: 1 year). 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 26 Jan 2023.