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Trial record 8 of 165 for:    PEMT

A Prospective Longitudinal Breast Cancer Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02270931
Recruitment Status : Active, not recruiting
First Posted : October 22, 2014
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Fujirebio Diagnostics, Inc.

Brief 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.

Condition or disease Intervention/treatment
Breast Cancer Device: CA 15-3 Assay

Detailed Description:

The study objectives are described below:

  1. 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.
  2. 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.

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Study Type : Observational
Estimated Enrollment : 130 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Longitudinal Study of CA 15-3 as an Aid in Monitoring Recurrence or Progressive Disease in Patients With Breast Cancer
Study Start Date : May 2014
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer


Intervention Details:
  • Device: CA 15-3 Assay
    Physicians use the CA 15-3 test result to manage their patients


Primary Outcome Measures :
  1. Measure CA 15-3 in Breast Cancer Patients [ Time Frame: 3 years ]
    130 patients with Recurrence or Progressive Breast Cancer.


Biospecimen Retention:   Samples Without DNA
Serum and Plasma


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02270931


Locations
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United States, Florida
Jane Skelton, MD
Boca Raton, Florida, United States, 33486
Broward Health Medical Center
Fort Lauderdale, Florida, United States, 33316
United States, North Carolina
New Hanover Regional Medical Center
Wilmington, North Carolina, United States, 28402
Sponsors and Collaborators
Fujirebio Diagnostics, Inc.
Investigators
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Study Director: Diana Dickson Fujirebio Diagnostics, Inc.

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Responsible Party: Fujirebio Diagnostics, Inc.
ClinicalTrials.gov Identifier: NCT02270931     History of Changes
Other Study ID Numbers: FDI-69
First Posted: October 22, 2014    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases