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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-01784 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2006-1072 | Other Identifier | M D Anderson Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Texas Appropriation for Rare and Aggressive diseases | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biospecimen Collection | Procedure | Undergo collection of blood, tissue, and stool |
|
| Measure | Description | Time Frame |
|---|---|---|
| Data, 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. | Up to 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with inflammatory or invasive breast cancer
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jie Willey | Contact | 713-792-3965 | jwilley@mdanderson.org |
| Name | Affiliation | Role |
|---|---|---|
| VIcente Valero, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner - MD Anderson Cancer Center | Recruiting | Gilbert | Arizona | 85234 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center | View source |
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Blood, tissue, stool
| Interview | Other | Participate in interview |
|
| Medical Chart Review | Other | Undergo collection of medical data |
|
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| Questionnaire Administration | Other | Ancillary Studies |
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| Scripps - MD Anderson Cancer Center | Active, not recruiting | La Jolla | California | 92037 | United States |
| Banner - MD Anderson Cancer Center - Northern Colorado | Recruiting | Greeley | Colorado | 80631 | United States |
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| Baptist - MD Anderson Cancer Center | Recruiting | Jacksonville | Florida | 32207 | United States |
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| Covenant Medical Center | Active, not recruiting | Saginaw | Michigan | 48604 | United States |
| M D Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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| MD Anderson in Katy | Recruiting | Houston | Texas | 77094 | United States |
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| MD Anderson League City | Recruiting | Nassau Bay | Texas | 77058 | United States |
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| MD Anderson in Sugar Land | Recruiting | Sugar Land | Texas | 77478 | United States |
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| MD Anderson in The Woodlands | Recruiting | The Woodlands | Texas | 77384 | United States |
|
| ID | Term |
|---|---|
| D058922 | Inflammatory Breast Neoplasms |
| D016609 | Neoplasms, Second Primary |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D007407 | Interviews as Topic |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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