This trial studies the biospecimen and medical data collection in creating a research tissue registry in patients with inflammatory or invasive breast cancer. Collecting medical data and storing samples of blood, tissue, and stool from patients with inflammatory breast cancer to study in the laboratory may help doctors find better ways to treat and study inflammatory breast cancer in the future.
PRIMARY OBJECTIVES: I. To prospectively collect tissue (including primary inflammatory breast cancer \[IBC\], ipsilateral nodal metastasis and/or distant metastasis \[if applicable\] obtained prior to primary systemic therapy and mastectomy/axillary dissection), serum, plasma, whole blood, clinical, and imaging data from patients with recently diagnosed inflammatory breast cancer (IBC), or highly suspicious for IBC, who have not received systemic therapy. II. To collect paraffin tissue blocks or unstained slides (including primary, ipsilateral nodal metastasis and/or distant metastasis \[if applicable\] obtained prior to primary systemic therapy), mastectomy/axillary dissection tissue, serum, plasma, whole blood, clinical, and imaging data (if available) from patients with previously diagnosed inflammatory breast cancer (IBC), who have been treated or partially treated, but have not had mastectomy and are seeking further treatment in the IBC clinic at M. D. Anderson or participating cancer network sites. III. To collect oral swab, skin and stool bacterial culture swab for microbiome analysis to compare patients with specific breast cancer subtype to report changes in flora during the course of treatment and correlated to toxicity. OUTLINE: Patients complete questionnaires and participate in interview over 30 minutes. Patients also undergo collection of medical data and blood, tissue, and stool samples.
Study Type
OBSERVATIONAL
Enrollment
1,200
Undergo collection of blood, tissue, and stool
Participate in interview
Undergo collection of medical data
Ancillary Studies
Banner - MD Anderson Cancer Center
Gilbert, Arizona, United States
RECRUITINGScripps - MD Anderson Cancer Center
La Jolla, California, United States
ACTIVE_NOT_RECRUITINGBanner - MD Anderson Cancer Center - Northern Colorado
Greeley, Colorado, United States
RECRUITINGBaptist - MD Anderson Cancer Center
Jacksonville, Florida, United States
RECRUITINGCovenant Medical Center
Saginaw, Michigan, United States
ACTIVE_NOT_RECRUITINGM D Anderson Cancer Center
Houston, Texas, United States
RECRUITINGMD Anderson in Katy
Houston, Texas, United States
RECRUITINGMD Anderson League City
Nassau Bay, Texas, United States
RECRUITINGMD Anderson in Sugar Land
Sugar Land, Texas, United States
RECRUITINGMD Anderson in The Woodlands
The Woodlands, Texas, United States
RECRUITINGData, serum, tissue, peripheral blood mononuclear cells, and plasma sample collection
No statistical considerations are provided. For each clinical question that will use the data collected in this registry, a separate protocol will be submitted to the Institutional Review Board (IRB) that will include a sample size justification and an analysis plan.
Time frame: Up to 2 years
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