Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00477100
Status:
RECRUITING
Last Update Posted:
2024-04-04
First Post:
2007-05-18
Brief Title:
Biospecimen and Medical Data Collection and Tumor Biopsy in Creating Research Tissue Registry in Patients with Inflammatory or Invasive Breast Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Inflammatory Breast Cancer IBC Registry
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
PRIMARY OBJECTIVES
I To prospectively collect tissue including primary inflammatory breast cancer IBC ipsilateral nodal metastasis andor distant metastasis if applicable obtained prior to primary systemic therapy and mastectomyaxillary 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 andor distant metastasis if applicable obtained prior to primary systemic therapy mastectomyaxillary 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
I To prospectively collect tissue including primary inflammatory breast cancer IBC ipsilateral nodal metastasis andor distant metastasis if applicable obtained prior to primary systemic therapy and mastectomyaxillary 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 andor distant metastasis if applicable obtained prior to primary systemic therapy mastectomyaxillary 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2018-01784 | REGISTRY | None | None |
| 2006-1072 | OTHER | M D Anderson Cancer Center | None |