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Analyzing the Composition of Tears to Identify Cancer (ACT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00574678
First Posted: December 17, 2007
Last Update Posted: February 3, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Tenenbaum Family Foundation
Information provided by (Responsible Party):
University of Arkansas
December 13, 2007
December 17, 2007
February 3, 2016
December 2006
February 2016   (Final data collection date for primary outcome measure)
This study will further evaluate the use of tumor markers (substances in body fluids that may be elevated as a consequence of certain diseases or conditions) in the diagnosis of breast and/or other cancers. [ Time Frame: Collection of specimen and analysis with SELDI-MS ]
Same as current
Complete list of historical versions of study NCT00574678 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Analyzing the Composition of Tears to Identify Cancer
ACT: Analyzing the Composition of Tears to Identify Cancer (Breast, Ovarian, Colon)
This study will further evaluate the use of protein identification or protein pattern (signature) found in tears. We hypothesize that differences exist between the protein profile in tear fluid from patients with versus without cancer.
Specifically, this study will compare the protein profile in tear fluid from patients with breast, ovarian or colon cancer versus "normal male and female patients" for differences that show promise as a diagnostic indicator. If such differences can be found, then their diagnostic potential will be assessed and developed further in a subsequent study. The long-term goal of this project will be to develop a screening tool for the detection of breast and/or other cancers.
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
  • Breast Cancer
  • Ovarian Cancer
  • Colon Cancer
  • Benign Disease
Other: Tear collection
A tear sample (~75 microliters in a tuberculin syringe with the needle removed) will be taken at time of the initial clinic visit. After collection, the tears will be put directly on ice and taken to the lab. If it is not possible to obtain natural tears, an "eye wash" method using sterile saline will be employed and the fluid collected using the aforementioned technique. The SELDI-MS process will be conducted on the specimen immediately. The remainder of the tear specimen will be stored in a -80ºC freezer until completely analyzed.
Other Name: SELDI-MS
No Intervention: 1
Intervention: Other: Tear collection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
February 2016
February 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Female or male, 18-100 years old
  • Patients who present for a routine check-up
  • Patients who present for the evaluation of an abnormal exam or test (mammogram, ultrasound, MRI, PET, etc.)
  • May or may not have a mass present
  • Patients who present for the evaluation of a palpable lump or mass
  • Patients may be pre or post biopsy for a mass, as long as there is a portion of the mass remaining

Exclusion Criteria:

  • Patient < 18 y/o or > 100 y/o
  • Concurrent eye infection or trauma
  • Active conjunctivitis
  • Abnormal production of tears (too much or too little)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00574678
UAMS 71853
No
Not Provided
Not Provided
University of Arkansas
University of Arkansas
Tenenbaum Family Foundation
Principal Investigator: V. Suzanne Klimberg, MD University of Arkansas
University of Arkansas
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP