Inflammatory Breast Carcinoma, Invasive Breast Carcinoma, Second Primary Malignant Neoplasm
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREBiospecimen Collection
Undergo collection of blood, tissue, and stool
OTHERInterview
Participate in interview
OTHERMedical Chart Review
Undergo collection of medical data
OTHERQuestionnaire Administration
Ancillary Studies
Sponsors
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Texas Appropriation for Rare and Aggressive diseases
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with clinical diagnosis of primary inflammatory breast cancer (IBC), second primary IBC, or highly suspicious for IBC (MD Anderson patients only). * Histological diagnosis of invasive breast cancer, or highly suspicious for IBC (MD Anderson patients only) but pending breast cancer diagnosis. * Be either newly diagnosed, or highly suspicious for IBC (MD Anderson patients only) \[Cohort I\] or have paraffin blocks or up to 20 unstained slides of each representative block(s) from the time of initial diagnosis of IBC(i.e. core biopsy and punch biopsy) and/or from mastectomy (Cohort II-MD Anderson patients only) * Age \> 18 years * Able to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Data, serum, tissue, peripheral blood mononuclear cells, and plasma sample collection | Up to 2 years | 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. |
Countries
United States
Contacts
CONTACTJie Willey
PRINCIPAL_INVESTIGATORVIcente Valero, MD
M.D. Anderson Cancer Center
Outcome results
None listed