Biospecimen and Medical Data Collection and Tumor Biopsy in Creating Research Tissue Registry in Patients With Inflammatory or Invasive Breast Cancer
NCT ID: NCT00477100
Last Updated: 2025-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1200 participants
OBSERVATIONAL
2007-04-17
2030-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Biospecimen Collection
Undergo collection of blood, tissue, and stool
Interview
Participate in interview
Medical Chart Review
Undergo collection of medical data
Questionnaire Administration
Ancillary Studies
Interventions
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Biospecimen Collection
Undergo collection of blood, tissue, and stool
Interview
Participate in interview
Medical Chart Review
Undergo collection of medical data
Questionnaire Administration
Ancillary Studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Texas Appropriation for Rare and Aggressive diseases
UNKNOWN
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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VIcente Valero, MD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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Banner - MD Anderson Cancer Center
Gilbert, Arizona, United States
Scripps - MD Anderson Cancer Center
La Jolla, California, United States
Banner - MD Anderson Cancer Center - Northern Colorado
Greeley, Colorado, United States
Baptist - MD Anderson Cancer Center
Jacksonville, Florida, United States
Covenant Medical Center
Saginaw, Michigan, United States
M D Anderson Cancer Center
Houston, Texas, United States
MD Anderson in Katy
Houston, Texas, United States
MD Anderson League City
Nassau Bay, Texas, United States
MD Anderson in Sugar Land
Sugar Land, Texas, United States
MD Anderson in The Woodlands
The Woodlands, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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MD Anderson Cancer Center
Other Identifiers
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NCI-2018-01784
Identifier Type: REGISTRY
Identifier Source: secondary_id
2006-1072
Identifier Type: OTHER
Identifier Source: secondary_id
2006-1072
Identifier Type: -
Identifier Source: org_study_id
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