- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03758976
Sweden Cancerome Analysis Network - Breast Recurrence (SCAN-B-rec)
SCAN-B-rec: Infrastructure, Technology Platform and Clinical Research Development to Profile and Monitor Metastatic Breast Cancer
Prospective multicenter observational study to assess molecular drivers of metastatic breast cancer and disease evolution upon therapeutic pressure.
The main aim is to develop and validate prognostic, predictive and pathogenic markers in clinically well-characterized population-based material of breast cancer tumors and the corresponding normal tissue.These data will be used to characterize recurrent breast cancer on a molecular level, study tumor evolution, develop biomarkers of response/resistance to targeted therapy in the metastatic setting, enroll patients on targeted treatment clinical studies and to elucidate mechanisms of resistance to therapy.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Karolina Holm, PhD
- Phone Number: +46 730 84 17 61
- Email: karolina.holm@med.lu.se
Study Contact Backup
- Name: Christel Reutersward, MSc
- Email: christel.reutersward@med.lu.se
Study Locations
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-
-
Lund, Sweden, 221 85
- Recruiting
- Lund University Hospital
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Principal Investigator:
- Åke Borg, Professor
-
Contact:
- Karolina Holm, MSc
- Phone Number: +46 730 84 47 61
- Email: karolina.holm@med.lu.se
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients with pathologically confirmed advanced breast cancer (ABC), including locally advanced inoperable disease and stage IV disease.
- Age > 18 years.
- Performance status according to Eastern Cooperative Oncology Group (ECOG) ≤ 2.
- ABC must be radiologically or clinically assessable, by means of at least one of the following techniques: clinical examination, computerized tomography (CT-scan), magnetic resonance imaging (MRI), bone scintigraphy or positron emission tomography (PET).
- Patients must have a radiological evaluation done maximum 6 weeks prior to inclusion.
- Signed informed consent according to ICH/GCP, and national/local regulations.
Exclusion Criteria:
Untreated psychiatric disorders that will impair the patient's ability to comply with study treatment or protocol.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Survival
Time Frame: 10 years
|
Prospective recording of treatment interventions and molecular characteristics in metastatic breast cancer patients until the date of Death.
|
10 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms by Site
- Neoplasms
- Neoplastic Processes
- Skin Diseases
- Breast Diseases
- Neoplasm Metastasis
- Pathological Conditions, Signs and Symptoms
- Skin and Connective Tissue Diseases
- Breast Neoplasms
- Neoplastic Cells, Circulating
- Investigative Techniques
- Therapeutics
- Specimen Handling
- Clinical Laboratory Techniques
- Diagnostic Techniques and Procedures
- Diagnosis
- Punctures
- Surgical Procedures, Operative
- Cytological Techniques
- Cytodiagnosis
- Diagnostic Techniques, Surgical
- Blood Specimen Collection
- Biopsy
- Phlebotomy
Other Study ID Numbers
- SCAN-B-rec
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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