Breast CancerNCT02270931
A Prospective Longitudinal Breast Cancer Study
An observational study of Breast Cancer, run by Fujirebio Diagnostics, Inc. at 3 sites in United States.
Trial summary
The purpose of this study is to obtain sufficient specimens and correlating clinical data from a well-controlled prospective clinical trial collecting longitudinal specimens from subjects diagnosed with any stage of breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- CA 15-3 Assay
- Type of treatment
- Medical device
- How many people
- 130 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2014to 30 Jun 2021
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Approximately 130 subjects will be enrolled in this study. Women and men greater than or equal to 18 years of age with a histologically/pathologically confirmed diagnosis of breast cancer and a minimum of three serial blood draws collected at disease evaluation time points, as determined by the treating physician's standard of care, will be eligible.
Who may be able to join
- Males and females, age≥ 18 years
- Histologic/pathologic confirmation of breast cancer
- Any stage of disease: Newly diagnosed, stable, disease progression, surveillance
- Any treatment time point: Treatment naïve, currently receiving or completed therapy for breast cancer including active monitoring.
- Individuals with a history of malignant disease other than breast cancer that was resected greater than 5 years ago and are currently in remission are eligible.
- Able to understand and willing to provide informed consent
Who cannot join
- Males and females, age <18 years
- No histologic/pathologic confirmation of breast cancer
- Any concurrent malignancy other than basal or squamous cell skin cancers, in-situ cervical cancer, or breast cancer.
- Treatment plan with fewer than three visits expected in 3 years' time
- Unable to provide informed consent
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Jane Skelton, MD
Boca Raton, Florida, 33486
Broward Health Medical Center
Fort Lauderdale, Florida, 33316
New Hanover Regional Medical Center
Wilmington, North Carolina, 28402
About this study
Official title: A Prospective Longitudinal Study of CA 15-3 as an Aid in Monitoring Recurrence or Progressive Disease in Patients With Breast Cancer
The purpose of this study is to obtain sufficient specimens and correlating clinical data from a well-controlled prospective clinical trial collecting longitudinal specimens from subjects diagnosed with any stage of breast cancer.
Read the detailed description
The study objectives are described below:
- Obtain serum and plasma specimens longitudinally collected from a minimum of 130 subjects diagnosed with breast cancer and are about to or are currently undergoing treatment and follow-up. Specimens will be used to evaluate CA 15-3 assays, currently under development, as an aid for monitoring recurrence or progressive disease.
- To store any remaining specimens for use in future cancer research and to evaluate as yet undetermined biomarkers for the development of IVDs, including additional CA 15-3 assays, for monitoring the course of disease and therapy in subjects diagnosed with breast cancer.
- Conditions
- Breast Cancer
- Being tested
- CA 15-3 Assay
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CA 15-3 AssayDevice
Physicians use the CA 15-3 test result to manage their patients
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure CA 15-3 in Breast Cancer Patients
130 patients with Recurrence or Progressive Breast Cancer.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2014 (estimated)
- Study startMay 2014
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
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
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujirebio Diagnostics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Diana Dickson, Study director, Fujirebio Diagnostics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02270931
- Sponsor's protocol ID
- FDI-69
- Status last verified
- Jul 2020
- First submitted
- 2 Oct 2014
- Last updated
- 17 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Longitudinal Study of CA 15-3 as an Aid in Monitoring Recurrence or Progressive Disease in Patients With Breast Cancer
- ClinicalTrials.gov ID
- NCT02270931
- Acronym / sponsor ID
- FDI-69
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Fujirebio Diagnostics, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 22 Oct 2014 (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 obtain sufficient specimens and correlating clinical data from a well-controlled prospective clinical trial collecting longitudinal specimens from subjects diagnosed with any stage of breast cancer.
Detailed description
The study objectives are described below:
- Obtain serum and plasma specimens longitudinally collected from a minimum of 130 subjects diagnosed with breast cancer and are about to or are currently undergoing treatment and follow-up. Specimens will be used to evaluate CA 15-3 assays, currently under development, as an aid for monitoring recurrence or progressive disease.
- To store any remaining specimens for use in future cancer research and to evaluate as yet undetermined biomarkers for the development of IVDs, including additional CA 15-3 assays, for monitoring the course of disease and therapy in subjects diagnosed with breast cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately 130 subjects will be enrolled in this study. Women and men greater than or equal to 18 years of age with a histologically/pathologically confirmed diagnosis of breast cancer and a minimum of three serial blood draws collected at disease evaluation time points, as determined by the treating physician's standard of care, will be eligible.
Key inclusion criteria (6 listed)
- Males and females, age≥ 18 years
- Histologic/pathologic confirmation of breast cancer
- Any stage of disease: Newly diagnosed, stable, disease progression, surveillance
- Any treatment time point: Treatment naïve, currently receiving or completed therapy for breast cancer including active monitoring.
- Individuals with a history of malignant disease other than breast cancer that was resected greater than 5 years ago and are currently in remission are eligible.
Key exclusion criteria (5 listed)
- Males and females, age <18 years
- No histologic/pathologic confirmation of breast cancer
- Any concurrent malignancy other than basal or squamous cell skin cancers, in-situ cervical cancer, or breast cancer.
- Treatment plan with fewer than three visits expected in 3 years' time
- Unable to provide informed consent
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 |
|---|---|---|
| CA 15-3 AssayPhysicians use the CA 15-3 test result to manage their patients | Device | – |
Primary outcome
Measure CA 15-3 in Breast Cancer Patients
Time frame: 3 years
130 patients with Recurrence or Progressive Breast Cancer.
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 17 Aug 2021.
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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.
Diana Dickson study director
Fujirebio Diagnostics, Inc.
3 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 Fujirebio Diagnostics, Inc. at 3 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 6 inclusion and 5 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 17 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
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?
Measure CA 15-3 in Breast Cancer Patients (time frame: 3 years). 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 17 Aug 2021; AzTrials last refreshed its copy on 28 Oct 2026.