Pilot Study of Bone Biopsy and Aspirate in Women With Metastatic Breast Cancer

NCT01975597 | Terminated DMC

• 2 other identifiers: UMCC 2013.053HUM00075575
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

This is a feasibility study to demonstrate the team's ability to collect bone marrow aspirates and biopsies for research purposes from women with metastatic breast cancer.

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Number of patient that agree to undergo 2 biopsy's strictly for research purposes.

  At 3 months

Study Arms (1)

Bone marrow aspirates and biopsy

Procedure: Bone marrow aspirates and biopsy

Interventions

Bone marrow aspirates and biopsy PROCEDURE

Bone marrow aspirates and biopsy

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are receiving care for metastatic breast cancer at University of Michigan Rogel Cancer Center will be recruited for this study to donate samples.

You may qualify if:

• Patients with metastatic breast cancer (any site) age 21 or older
• Patients willing and able to provide informed consent \& perform study procedures
• Patients may enroll with recently (with 2 months) progressive tumor burden
• Performance status of 0,1 or 2

You may not qualify if:

• Patients unable or unwilling to provide informed consent and or perform study procedures
• Patients with active, uncontrolled coagulopathy
• Patients on treatment dose anticoagulation or an International Normalised Ratio of 2 or greater if on warfarin
• Patients who are known to be pregnant are not eligible to participate in this study during the time of the pregnancy

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Bone marrow, peripheral blood, tumor tissue

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Catherine Van Poznak, MD

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2013
• First Posted: November 4, 2013
• Study Start: August 1, 2013
• Primary Completion: November 19, 2014
• Study Completion: November 19, 2014
• Last Updated: September 1, 2023

Record last verified: 2023-08

Locations

US (1)