Biospecimen and Medical Data Collection and Tumor Biopsy in Creating Research Tissue Registry in Patients With Inflammatory or Invasive Breast Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
PRIMARY OBJECTIVES:
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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.
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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.
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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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Observational (biospecimen and medical data collection) Patients complete questionnaires and participate in interview over 30 minutes. Patients also undergo collection of medical data and blood, tissue, and stool samples. |
Procedure: Biospecimen Collection
Undergo collection of blood, tissue, and stool
Other: Interview
Participate in interview
Other: Medical Chart Review
Undergo collection of medical data
Other Names:
Other: Questionnaire Administration
Ancillary Studies
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Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients with clinical diagnosis of primary inflammatory breast cancer (IBC), second primary IBC, or highly suspicious for IBC (MD Anderson patients only).
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Histological diagnosis of invasive breast cancer, or highly suspicious for IBC (MD Anderson patients only) but pending breast cancer diagnosis.
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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)
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Age > 18 years
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Able to provide informed consent
Exclusion Criteria:
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | M D Anderson Cancer Center | Houston | Texas | United States | 77030 |
| 2 | MD Anderson in Katy | Houston | Texas | United States | 77094 |
| 3 | MD Anderson League City | Nassau Bay | Texas | United States | 77058 |
| 4 | MD Anderson in Sugar Land | Sugar Land | Texas | United States | 77478 |
| 5 | MD Anderson in The Woodlands | The Woodlands | Texas | United States | 77384 |
Sponsors and Collaborators
- M.D. Anderson Cancer Center
- National Cancer Institute (NCI)
- Texas Appropriation for Rare and Aggressive diseases
Investigators
- Principal Investigator: Naoto T Ueno, M.D. Anderson Cancer Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 2006-1072
- NCI-2018-01784
- 2006-1072