NCT00477100 · M.D. Anderson Cancer Center
Biospecimen and Medical Data Collection and Tumor Biopsy in Creating Research Tissue Registry in Patients With Inflammatory or Invasive Breast Cancer
What this study is about
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.
View original scientific description
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.
Interventions
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
Questionnaire Administration
Ancillary Studies
Primary outcome measures
Data, serum, tissue, peripheral blood mononuclear cells, and plasma sample collection
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Gilbert, Arizona
- La Jolla, California
- Greeley, Colorado
- Jacksonville, Florida
- Saginaw, Michigan
- Houston, Texas
- Nassau Bay, Texas
- Sugar Land, Texas
- The Woodlands, Texas
Collaborators
National Cancer Institute (NCI), Texas Appropriation for Rare and Aggressive diseases
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 15, 2026 · Source of record for eligibility and locations