Clinical trial NCT01075607: Lymph Fluid and Blood Collection for Identification of Novel Biomarkers
Official title: The Comparison of Lymph Fluid and Blood From Metastatic and Non-metastatic Invasive Breast Cancer Patients for Identification of Novel Biomarkers
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Adenocarcinoma of the Breast
Keywords: Lymph fluid collection
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2010-02-25
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with adenocarcinoma of the breast - no prior chemotherapy treatment.

Brief summary: The objective of this study is to identify and validate metastasis protein markers in lymph collected from women with metastatic breast cancer. We will examine 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Identification and Validation of Metastasis Protein Markers
timeFrame: Every 6 mo. for 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Hospital
state: Indiana
Study officials:
affiliation: Indiana University
name: Monet Bowling, MD
role: PRINCIPAL_INVESTIGATOR
References: