Breast CancerNCT02574546
Markers for Predicting Risk of Breast Cancer in Women of Different Races
An observational study of Breast Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
This research is being done to learn more about the risk of developing breast cancer by studying cells from both normal breast tissue and breast cancer tumor tissue. The goal is to study cells, genes, and gene products to help us to learn how to detect cancer in its earliest stages, and if this information may differ… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Mastectomy
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to Jan 2020
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with a newly diagnosed breast cancer planning planning surgical management with mastectomy.
Who may be able to join
- Women
- 18 years and older
- Histologically proven infiltrating carcinoma of the breast on diagnostic biopsy. NOTE: Individuals planning bilateral mastectomy procedures (for either bilateral cancers or contralateral prophylactic procedures) either at the same time or in the future will be asked to have tissue removed for the study from both breasts.
- ER-negative, any PR status, and any HER2 status (i.e., ER-, PR any, HER2- or ER-, PR any, HER2+; "triple positive" breast cancers are not eligible).
- Unresected, untreated breast cancer planning surgical management with mastectomy (with or without axillary nodal evaluation/dissection and/or with any other clinical assessment).
- Willing and able to sign an informed consent form
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
United States1 site
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21287-0013
About this study
Official title: Molecular Markers for Predicting Risk of Developing Breast Cancer in Different Ethnicities
This research is being done to learn more about the risk of developing breast cancer by studying cells from both normal breast tissue and breast cancer tumor tissue. The goal is to study cells, genes, and gene products to help us to learn how to detect cancer in its earliest stages, and if this information may differ in patients with different ethnic backgrounds.
Read the detailed description
Evidence suggests that, besides reduced access to care, the increase in breast cancer incidence and mortality in AA (African American) compared to EA (European American or Caucasian) women is influenced by the biology of the tumor. Gene methylation changes caused by environmental factors starting at birth is one mechanism through which genetic and non-genetic factors could affect development of breast cancer and which could underlie disparities in aggressiveness. The investigators were the first to show that a panel of genes was hypermethylated specifically in AA-ER-negative tumors in young women in comparison to EA-tumors in women of the same age. Gene promoter methylation is found at low levels in healthy breast tissues from women without cancer. Race and family history of cancer increase the likelihood of these early events. Thus, epigenetic changes may be early events in transformation of breast cells and tumor formation.
This study will enroll women from different ethnic backgrounds undergoing mastectomy in order to collect normal and tumor tissue to study these genetic changes and breast cancer risk.
- Conditions
- Breast Cancer
- Being tested
- Mastectomy
- Keywords
- Mastectomy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MastectomyProcedure or surgery
Unilateral breast cancers planning bilateral mastectomy procedures.
| Study group | Role | What they receive |
|---|---|---|
| Surgery | Women undergoing mastectomy are eligible for enrollment. Receives: Procedure: Mastectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genetic changes in cells taken from the breasts of women undergoing mastectomy
Measured: Time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2015 (estimated)
- Study startJan 2017 (estimated)
- Primary completionJan 2019 (estimated)
- Study completionJan 2020 (estimated)
Why it stopped: Difficulty acquiring fresh tissue from mastectomy specimens.
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 Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe 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
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Saraswati Sukumar, Ph.D., Study chair, SKCCC at Johns Hopkins
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02574546
- Sponsor's protocol ID
- J1585
- Other IDs
- IRB00059654
- Status last verified
- Feb 2019
- First submitted
- 6 Oct 2015
- Last updated
- 25 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Markers for Predicting Risk of Developing Breast Cancer in Different Ethnicities
- ClinicalTrials.gov ID
- NCT02574546
- Acronym / sponsor ID
- J1585
- Conditions
- Breast Cancer
- Keywords
- Mastectomy
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Difficulty acquiring fresh tissue from mastectomy specimens.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- Jan 2017 (estimated)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 14 Oct 2015 (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.
This research is being done to learn more about the risk of developing breast cancer by studying cells from both normal breast tissue and breast cancer tumor tissue. The goal is to study cells, genes, and gene products to help us to learn how to detect cancer in its earliest stages, and if this information may differ in patients with different ethnic backgrounds.
Detailed description
Evidence suggests that, besides reduced access to care, the increase in breast cancer incidence and mortality in AA (African American) compared to EA (European American or Caucasian) women is influenced by the biology of the tumor. Gene methylation changes caused by environmental factors starting at birth is one mechanism through which genetic and non-genetic factors could affect development of breast cancer and which could underlie disparities in aggressiveness. The investigators were the first to show that a panel of genes was hypermethylated specifically in AA-ER-negative tumors in young women in comparison to EA-tumors in women of the same age. Gene promoter methylation is found at low levels in healthy breast tissues from women without cancer. Race and family history of cancer increase the likelihood of these early events. Thus, epigenetic changes may be early events in transformation of breast cells and tumor formation.
This study will enroll women from different ethnic backgrounds undergoing mastectomy in order to collect normal and tumor tissue to study these genetic changes and breast cancer risk.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgery | – | Procedure: MastectomyWomen undergoing mastectomy are eligible for enrollment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with a newly diagnosed breast cancer planning planning surgical management with mastectomy.
Key inclusion criteria (6 listed)
- Women
- 18 years and older
- Histologically proven infiltrating carcinoma of the breast on diagnostic biopsy. NOTE: Individuals planning bilateral mastectomy procedures (for either bilateral cancers or contralateral prophylactic procedures) either at the same time or in the future will be asked to have tissue removed for the study from both breasts.
- ER-negative, any PR status, and any HER2 status (i.e., ER-, PR any, HER2- or ER-, PR any, HER2+; "triple positive" breast cancers are not eligible).
- Unresected, untreated breast cancer planning surgical management with mastectomy (with or without axillary nodal evaluation/dissection and/or with any other clinical assessment).
Key exclusion criteria (1 listed)
- None.
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 |
|---|---|---|
| MastectomyUnilateral breast cancers planning bilateral mastectomy procedures. | Procedure or surgery | Surgery |
Primary outcome
Genetic changes in cells taken from the breasts of women undergoing mastectomy
Time frame: Time of surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2019.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Saraswati Sukumar, Ph.D. study chair
SKCCC at Johns Hopkins
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 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins 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 6 inclusion and 1 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: withdrawn, as of the sponsor's last update on 25 Feb 2019. 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 was withdrawn before enrolling participants, so there are no results.
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?
Genetic changes in cells taken from the breasts of women undergoing mastectomy (time frame: Time of surgery). 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 25 Feb 2019.