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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
Trial Status: active
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 and tissue 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.
Inclusion Criteria
Have clinical diagnosis of primary inflammatory breast cancer (IBC), second primary IBC, or highly suspicious for IBC
* NOTE: The diagnosis of inflammatory breast cancer is according to the international consensus criteria:
** Onset: Rapid onset of breast erythema or skin change, edema, and/or peau d’orange, and/or warm breast, with or without an underlying breast mass
** Duration: History of such findings no more than 6 months
** Extent: Erythema or breast skin change occupying at least 1/3 of whole breast
** Pathology: Pathologic confirmation of invasive carcinoma of the breast
Have histological diagnosis of invasive breast cancer, or highly suspicious for IBC but pending inflammatory breast cancer diagnosis, or seen in the IBC multi-team clinic or IBC QA due to consideration of IBC but deemed not IBC
Be either newly diagnosed and haven’t been treated (Cohort I/III), or have been treated (Cohort II/III)
Be 18 years of age or older
Be able to understand and provide signed informed consent
Pregnant patients may be enrolled, as study activities are non-interventional and pose minimal risk to the patient and fetus
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT00477100.
I. To prospectively collect tissue (including primary, ipsilateral nodal metastasis and/or distant metastasis [if applicable] obtained prior to primary systemic therapy and mastectomy/axillary dissection), serum, plasma, whole blood, clinical, imaging and questionnaire data from patients with recently diagnosed inflammatory breast cancer (IBC), or suspicious for IBC (based on referral to IBC multi-team clinic or IBC QA).
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 imaging and questionnaire data (if available) from patients with previously diagnosed inflammatory breast cancer (IBC), who have been treated or partially treated, and are seeking further treatment in the IBC clinic at M. D. Anderson, or participating Cancer Network, or other participating sites.
III. To prospectively collect tissue (including primary, recurrence, ipsilateral nodal metastasis and/or distant metastasis [if applicable] obtained after any systemic therapy and/or mastectomy/axillary dissection), serum, plasma, whole blood, clinical, imaging and questionnaire data from patients with recently diagnosed inflammatory breast cancer (IBC), or highly suspicious for IBC.
IV. To incorporate IBC specific patient reported outcomes in the care of IBC patients.
OUTLINE:
Patients complete questionnaires and participate in interview over 30 minutes. Patients also undergo collection of medical data and blood and tissue samples.
