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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial population

Participants with inflammatory or invasive breast cancer

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo collection of blood, tissue, and stool

  • Interview

    Other intervention

    Participate in interview

  • Medical Chart Review

    Other intervention

    Undergo collection of medical data

  • Questionnaire Administration

    Other intervention

    Ancillary Studies

Treatment groups

1,200 Participants
are divided into 1 treatment group
Group A: Observational (biospecimen and medical data collection)4 interventions

Trial outcomes

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.

Time frame
Up to 2 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Texas Appropriation for Rare and Aggressive diseases

Collaborator