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

NCT00477100 | Recruiting

• 2 other identifiers: 2006-1072NCI-2018-01784
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 10

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.

Conditions

Inflammatory Breast Carcinoma; Invasive Breast Carcinoma; Second Primary Malignant Neoplasm

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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; Other: Interview; Other: Medical Chart Review; Other: Questionnaire Administration

Interventions

Biospecimen Collection PROCEDURE

Undergo collection of blood, tissue, and stool

Observational (biospecimen and medical data collection)

Interview OTHER

Participate in interview

Observational (biospecimen and medical data collection)

Medical Chart Review OTHER

Undergo collection of medical data

Also known as: Chart Review

Observational (biospecimen and medical data collection)

Questionnaire Administration OTHER

Ancillary Studies

Observational (biospecimen and medical data collection)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with inflammatory or invasive breast cancer

You may qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator
• Texas Appropriation for Rare and Aggressive diseases: collaborator

Study Sites (10)

Banner - MD Anderson Cancer Center

Gilbert, Arizona, 85234, United States

RECRUITING

Scripps - MD Anderson Cancer Center

La Jolla, California, 92037, United States

ACTIVE NOT RECRUITING

Banner - MD Anderson Cancer Center - Northern Colorado

Greeley, Colorado, 80631, United States

RECRUITING

Baptist - MD Anderson Cancer Center

Jacksonville, Florida, 32207, United States

RECRUITING

Covenant Medical Center

Saginaw, Michigan, 48604, United States

ACTIVE NOT RECRUITING

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

MD Anderson in Katy

Houston, Texas, 77094, United States

RECRUITING

MD Anderson League City

Nassau Bay, Texas, 77058, United States

RECRUITING

MD Anderson in Sugar Land

Sugar Land, Texas, 77478, United States

RECRUITING

MD Anderson in The Woodlands

The Woodlands, Texas, 77384, United States

RECRUITING

Related Links

• MD Anderson Cancer Center

Biospecimen

Retention: SAMPLES WITH DNA

Blood, tissue, stool

MeSH Terms

Conditions

Inflammatory Breast Neoplasms; Neoplasms, Second Primary

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• VIcente Valero, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jie Willey

CONTACT

713-792-3965; jwilley@mdanderson.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2007
• First Posted: May 22, 2007
• Study Start: April 17, 2007
• Primary Completion (Estimated): April 30, 2030
• Study Completion (Estimated): April 30, 2030
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

US (10)