Expired Study
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Little Rock, Arkansas 72205


Purpose:

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.


Study summary:

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.


Criteria:

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)


Study is Available At:


Original ID:

UAMS 71853


NCT ID:

NCT00574678


Secondary ID:


Study Acronym:

ACT


Brief Title:

Analyzing the Composition of Tears to Identify Cancer


Official Title:

ACT: Analyzing the Composition of Tears to Identify Cancer (Breast, Ovarian, Colon)


Overall Status:

Completed


Study Phase:

Phase 1/Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Arkansas


Oversight Authority:

  • United States: Food and Drug Administration
  • United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Intervention Model: Si


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

150


Enrollment Type:

Actual


Overall Contact Information

Official Name:V. Suzanne Klimberg, MD
Principal Investigator
University of Arkansas

Study Dates

Start Date:December 2006
Completion Date:February 2016
Completion Type:Actual
Primary Completion Date:February 2016
Primary Completion Type:Actual
Verification Date:February 2016
Last Changed Date:February 2, 2016
First Received Date:December 13, 2007

Study Outcomes

Outcome Type: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
Safety Issues:False

Study Interventions

Intervention Type:Other
Name:Tear collection
Description: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 -8
Arm Name:1
Other Name:SELDI-MS

Study Arms

Study Arm Type:No Intervention
Arm Name:1

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Arkansas
Agency Class:Other
Agency Type:Collaborator
Agency Name:Tenenbaum Family Foundation

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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