Lymph Fluid and Blood Collection for Identification of Novel Biomarkers
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|ClinicalTrials.gov Identifier: NCT01075607|
Recruitment Status : Terminated (Halted prematurely due to lack of funding.)
First Posted : February 25, 2010
Last Update Posted : March 28, 2012
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|Condition or disease|
|Adenocarcinoma of the Breast|
The goal of the study is to identify node-negative breast cancer patients who are unlikely to benefit from adjuvant chemotherapy, thus saving them from the adverse effects of unnecessary treatment. We propose to identify and validate protein markers that can determine breast cancer recurrence and metastasis, based on an approach our group has recently found highly promising for biomarker discovery.
The objective of our research is to identify and validate metastasis protein markers in lymph collected from vessels exiting from the primary tumor and prior to their entry into sentinel lymph node in women with metastatic breast cancer. Realizing that this novel procedure cannot be adopted for routine clinical use, we will examine the peripheral blood for the presence of these identified markers in order to develop a user friendly clinical test to detect metastasis and to evaluate response to therapy.
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||The Comparison of Lymph Fluid and Blood From Metastatic and Non-metastatic Invasive Breast Cancer Patients for Identification of Novel Biomarkers|
|Study Start Date :||April 2010|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||April 2022|
- Identification and Validation of Metastasis Protein Markers [ Time Frame: Every 6 mo. for 5 years ]Lymph fluid collected at surgery; blood collected at surgery and then every 6 months for 5 years.
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|Ages Eligible for Study:||18 Years to 80 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- Women, age greater than or equal to 18, with histologically and/or cytologically confirmed diagnosis of adenocarcinoma of the breast with metastatic (node positive) and/or non-metastatic (node negative) breast cancer.
- No prior chemotherapy treatment.
- Women, age greater than or equal to 18, with carcinoma in situ that opted for mastectomy.
- Able to provide informed consent and HIPAA authorization.
- Hormone therapy in the past six months. Birth control pill use is allowed.
- History of radiation therapy to the chest.
- Previous or current use of aromatase inhibitor (AI) or Selective Estrogen Receptor Modulator (SERM) medication.
- History of chemotherapy for breast or other cancers.
- Pregnant or breast-feeding.
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): NCT01075607
|United States, Indiana|
|Indiana University Hospital|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator:||Monet Bowling, MD||Indiana University|
|Responsible Party:||Indiana University|
|Other Study ID Numbers:||
|First Posted:||February 25, 2010 Key Record Dates|
|Last Update Posted:||March 28, 2012|
|Last Verified:||March 2012|
Lymph fluid collection
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type