Biospecimen and Medical Data Collection and Tumor Biopsy in Creating Research Tissue Registry in Patients With Inflammatory or Invasive Breast Cancer

Invasive Breast Carcinoma Clinical Trial

Official title:

Inflammatory Breast Cancer (IBC) Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00477100
• Other study ID #: 2006-1072
• Secondary ID: NCI-2018-0178420
• Status: Recruiting
• Start date: April 17, 2007
• Est. completion date: April 30, 2030

Study information

• Verified date: April 2024
• Source: M.D. Anderson Cancer Center
• Contact: Jie Willey
• Phone: 713-792-3965
• Email: jwilley[@]mdanderson.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: April 30, 2030
• Est. primary completion date: April 30, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 Exclusion Criteria:

Related Conditions & MeSH terms

• Breast Neoplasms
• Carcinoma
• Inflammatory Breast Carcinoma
• Invasive Breast Carcinoma
• Neoplasms
• Second Primary Malignant Neoplasm

Intervention

Procedure:
• Biospecimen Collection
Undergo collection of blood, tissue, and stool

Other:
• Interview
Participate in interview
• Medical Chart Review
Undergo collection of medical data
• Questionnaire Administration
Ancillary Studies

Locations

Country	Name	City	State
United States	Banner - MD Anderson Cancer Center	Gilbert	Arizona
United States	Banner - MD Anderson Cancer Center - Northern Colorado	Greeley	Colorado
United States	M D Anderson Cancer Center	Houston	Texas
United States	MD Anderson in Katy	Houston	Texas
United States	Baptist - MD Anderson Cancer Center	Jacksonville	Florida
United States	Scripps - MD Anderson Cancer Center	La Jolla	California
United States	MD Anderson League City	Nassau Bay	Texas
United States	Covenant Medical Center	Saginaw	Michigan
United States	MD Anderson in Sugar Land	Sugar Land	Texas
United States	MD Anderson in The Woodlands	The Woodlands	Texas

Sponsors (3)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI), Texas Appropriation for Rare and Aggressive diseases

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   MD Anderson Cancer Center