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

  • STATUS
    Recruiting
  • End date
    Apr 30, 2030
  • participants needed
    1200
  • sponsor
    M.D. Anderson Cancer Center
Updated on 10 May 2022
breast carcinoma
invasive breast cancer
mastectomy
inflammatory breast cancer
core needle biopsy

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.

Details
Condition Inflammatory Breast Carcinoma, Invasive Breast Carcinoma, Second Primary Malignant Neoplasm
Treatment questionnaire administration, medical chart review, Interview, Blood and Tissue Collection, biospecimen collection
Clinical Study IdentifierNCT00477100
SponsorM.D. Anderson Cancer Center
Last Modified on10 May 2022

Eligibility

Yes No Not Sure

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
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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