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

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ClinicalTrials.gov Identifier: NCT00477100
Recruitment Status : Recruiting
First Posted : May 22, 2007
Last Update Posted : July 14, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment
Inflammatory Breast Carcinoma Invasive Breast Carcinoma Second Primary Malignant Neoplasm Procedure: Biospecimen Collection Other: Interview Other: Medical Chart Review Other: Questionnaire Administration

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 1200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Inflammatory Breast Cancer (IBC) Registry
Actual Study Start Date : April 17, 2007
Estimated Primary Completion Date : April 30, 2022
Estimated Study Completion Date : April 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort Intervention/treatment
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
Undergo collection of blood, tissue, and stool

Other: Interview
Participate in interview

Other: Medical Chart Review
Undergo collection of medical data
Other Name: Chart Review

Other: Questionnaire Administration
Ancillary Studies




Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples With DNA
Blood, tissue, stool


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants with inflammatory or invasive breast cancer
Criteria

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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00477100


Contacts
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Contact: Jie Willey 713-792-3965 jwilley@mdanderson.org

Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Naoto T. Ueno    713-792-2817      
Principal Investigator: Naoto T. Ueno         
MD Anderson in Katy Recruiting
Houston, Texas, United States, 77094
Contact: Naoto T. Ueno    713-792-8754    nueno@mdanderson.org   
Principal Investigator: Naoto T. Ueno         
MD Anderson League City Recruiting
Nassau Bay, Texas, United States, 77058
Contact: Naoto T. Ueno    713-792-8754    nueno@mdanderson.org   
Principal Investigator: Naoto T. Ueno         
MD Anderson in Sugar Land Recruiting
Sugar Land, Texas, United States, 77478
Contact: Naoto T. Ueno    713-792-8754    nueno@mdanderson.org   
Principal Investigator: Naoto T. Ueno         
MD Anderson in The Woodlands Recruiting
The Woodlands, Texas, United States, 77384
Contact: Naoto T. Ueno    713-792-8754    nueno@mdanderson.org   
Principal Investigator: Naoto T. Ueno         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Naoto T Ueno M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00477100    
Other Study ID Numbers: 2006-1072
NCI-2018-01784 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2006-1072 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: May 22, 2007    Key Record Dates
Last Update Posted: July 14, 2021
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Breast Neoplasms
Neoplasms
Inflammatory Breast Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Breast Diseases
Skin Diseases