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A Prospective Longitudinal Breast Cancer Study

Sponsor
Fujirebio Diagnostics, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02270931
Collaborator
(none)
130
Enrollment
3
Locations
86
Duration (Months)
43.3
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • 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.

Study Design

Study Type:
Observational
Anticipated 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 1, 2014
Actual Primary Completion Date :
Jun 30, 2021
Actual Study Completion Date :
Jun 30, 2021

Outcome Measures

Primary Outcome Measures

  1. Measure CA 15-3 in Breast Cancer Patients [3 years]

    130 patients with Recurrence or Progressive Breast Cancer.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Jane Skelton, MD Boca Raton Florida United States 33486
2 Broward Health Medical Center Fort Lauderdale Florida United States 33316
3 New Hanover Regional Medical Center Wilmington North Carolina United States 28402

Sponsors and Collaborators

  • Fujirebio Diagnostics, Inc.

Investigators

  • Study Director: Diana Dickson, Fujirebio Diagnostics, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fujirebio Diagnostics, Inc.
ClinicalTrials.gov Identifier:
NCT02270931
Other Study ID Numbers:
  • FDI-69
First Posted:
Oct 22, 2014
Last Update Posted:
Aug 17, 2021
Last Verified:
Jul 1, 2020
Additional relevant MeSH terms:
Breast Neoplasms

Study Results

No Results Posted as of Aug 17, 2021