Breast CancerNCT02712645
A Multicenter Breast Cancer Biospecimen Registry
An observational study of Breast Cancer, run by Luminist, Inc. at 2 sites in United States.
Trial summary
This study is being performed to collect blood for the development of noninvasive tests that can screen for or diagnose cancer. Blood samples will be collected from women who are scheduled to have breast biopsies. Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 700 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2016to Dec 2017
- How long will I take part?
- 1 Year
- 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 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women scheduled for a breast biopsy.
Who may be able to join
- Females of all racial and ethnic groups who are 40 years or older.
- Women must:
- have suspected neoplasm of the breast (BIRADS 4 or 5) based on the results of any breast screening or diagnostic imaging, such as mammogram, and
- be selected or scheduled for a breast biopsy which has not yet been conducted at the time of enrollment.
Who cannot join
- Inability to sign informed consent.
- More than one radiological finding.
- Any current or prior cancer (with the exception of non-melanoma skin cancer or a suspected breast malignancy targeted for biopsy).
- Any known or suspected acute illness or condition - including acute infections - at the time of enrollment or within the previous 30 days.
- Any surgery, hospitalization, or institutionalization (such as in a nursing home) during the previous 3 months.
- Received any experimental therapeutic treatment during the previous 3 months.
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- Received any blood product transfusion within the previous 3 months.
- Use of illegal drugs during the previous 3 months.
- Pregnant or nursing at the time of enrollment or in the preceding 12 months.
Trial locations and contacts
2 sites in 1 country.
Storm Stillman contact
Will Olsen contact
United States2 sites, 2 recruiting
- Recruiting
Study site
Dallas, Texas
- Recruiting
Study site
Redding, California
About this study
This study is being performed to collect blood for the development of noninvasive tests that can screen for or diagnose cancer. Blood samples will be collected from women who are scheduled to have breast biopsies.
- Conditions
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with untreated newly diagnosed breast cancer.
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 posted18 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completionDec 2017 (estimated)
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.
- 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
- 700 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Luminist, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02712645
- Sponsor's protocol ID
- LUM-BC-1.0
- Status last verified
- Apr 2016
- First submitted
- 15 Mar 2016
- Last updated
- 6 Apr 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Breast Cancer Biospecimen Registry
- ClinicalTrials.gov ID
- NCT02712645
- Acronym / sponsor ID
- LUM-BC-1.0
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Luminist, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2016
- Primary completion
- Dec 2017 (estimated)
- First posted
- 18 Mar 2016 (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 study is being performed to collect blood for the development of noninvasive tests that can screen for or diagnose cancer. Blood samples will be collected from women who are scheduled to have breast biopsies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women scheduled for a breast biopsy.
Key inclusion criteria (4 listed)
- Females of all racial and ethnic groups who are 40 years or older.
- Women must:
Key exclusion criteria (9 listed)
- Inability to sign informed consent.
- More than one radiological finding.
- Any current or prior cancer (with the exception of non-melanoma skin cancer or a suspected breast malignancy targeted for biopsy).
- Any known or suspected acute illness or condition - including acute infections - at the time of enrollment or within the previous 30 days.
- Any surgery, hospitalization, or institutionalization (such as in a nursing home) during the previous 3 months.
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
Number of patients with untreated newly diagnosed breast cancer.
Time frame: 1 Year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2016.
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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.
Storm Stillman contact
Will Olsen contact
2 sites 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 Luminist, Inc. at 2 sites 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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 6 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Storm Stillman (clinical@luminist.io), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with untreated newly diagnosed breast cancer. (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 6 Apr 2016.