Collecting and Storing Tissue Samples From Women With or Without Breast Cancer
This study is currently recruiting participants.
Verified April 2013 by Vanderbilt-Ingram Cancer Center
Sponsor:
Vanderbilt-Ingram Cancer Center
Collaborator:
Information provided by (Responsible Party):
A Bapsi Chakravarthy, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT00899301
First received: May 9, 2009
Last updated: April 10, 2013
Last verified: April 2013
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Purpose
RATIONALE: Collecting and storing samples of tissue, blood, and urine from patients with or without breast cancer to study in the laboratory may help the study of cancer.
PURPOSE: This research study is collecting and storing tissue samples from women with or without breast cancer.
| Condition | Intervention |
|---|---|
|
Breast Cancer |
Other: biologic sample preservation procedure |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Breast Tissue/Body Fluids Repository |
Resource links provided by NLM:
Further study details as provided by Vanderbilt-Ingram Cancer Center:
Primary Outcome Measures:
- Creation of a tissue repository that contains DNA, RNA, or protein from tumor tissue or normal tissue, peripheral blood lymphocytes, and plasma that are linked to frozen and/or paraffin-embedded pathology specimens [ Time Frame: 5 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 4000 |
| Study Start Date: | January 2004 |
| Estimated Study Completion Date: | January 2015 |
| Estimated Primary Completion Date: | January 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Patients with Breast Cancer |
Other: biologic sample preservation procedure
Tissue, urine and blood collection.
|
| Patients without breast cancer |
Other: biologic sample preservation procedure
Tissue, urine and blood collection.
|
Detailed Description:
OBJECTIVES:
- To create a database that includes environmental, demographic, phenotypic, clinical, pathologic, genetic, and prognostic factors in large cohorts of women with different stages of breast cancer.
- To create a tissue repository that contains DNA, RNA, or protein from tumor tissue or normal tissue, peripheral blood lymphocytes, and plasma that are linked to frozen and/or paraffin-embedded pathology specimens.
OUTLINE: Patients undergo tumor tissue and normal tissue sample collection at the time of medically indicated surgery or biopsy. Archival tissue may also be collected. Patients and normal volunteers also undergo blood and urine sample collection. A repository of tissue, blood, and urine samples will be established to facilitate current and future research studies to learn about the biologic features of breast cancer development and progression. Research studies may include molecular pathology studies and gene and protein expression studies.
Patients' medical records are reviewed over approximately 5 years to determine if the test results are associated with health status. Patients do not receive the results of individual testing.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients with and without breast cancer.
Criteria
- Any subject > 18 years of age with a breast lesion which is suspected to be cancer or a known breast cancer lesion (primary or metastatic) who agrees to donate tissue/body fluids. Collection of samples can occur:
- At the time of breast biopsy or surgery for benign disease
- At the time of breast biopsy or surgery for suspected breast cancer
- At the time of biopsy or surgery for histologically proven breast cancer at any stage of disease.
- From archival materials
- In a normal volunteer who wishes to donate blood and/or urine to allow for a control population against whom the cancer patient can be compared
- Subjects have to sign informed consent for study of tumor specimens as part of a research project.
- Patients have to give permission for their tumor specimens to be obtained from outside institutions for molecular analyses.
- All subjects participating in this protocol have to be willing to be followed for recurrence, relapse and death from disease.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00899301
Locations
| United States, Tennessee | |
| Vanderbilt-Ingram Cancer Center - Cool Springs | Recruiting |
| Nashville, Tennessee, United States, 37064 | |
| Contact: VICC Clnical Trials Information Program 800-811-8480 | |
| Vanderbilt-Ingram Cancer Center at Franklin | Recruiting |
| Nashville, Tennessee, United States, 37064 | |
| Contact: VICC Clnical Trials Information Program 800-811-8480 | |
| Vanderbilt-Ingram Cancer Center | Recruiting |
| Nashville, Tennessee, United States, 37232-6838 | |
| Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center 800-811-8480 | |
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
Investigators
| Principal Investigator: | A. Bapsi Chakravarthy, MD | Vanderbilt-Ingram Cancer Center |
| Principal Investigator: | Mark Kelley, MD, FACS | Vanderbilt-Ingram Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | A Bapsi Chakravarthy, MD, Associate Professor; Radiation Oncologist, Vanderbilt-Ingram Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00899301 History of Changes |
| Other Study ID Numbers: | VICC BRE 03103, P30CA068485, VU-VICC-BRE-03103, VU-VICC-030747 |
| Study First Received: | May 9, 2009 |
| Last Updated: | April 10, 2013 |
| Health Authority: | United States: Vanderbilt University Human Research Protection Program |
Keywords provided by Vanderbilt-Ingram Cancer Center:
|
breast cancer stage IA breast cancer stage IB breast cancer stage II breast cancer |
stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer stage IV breast cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on May 23, 2013