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Trial record 7 of 13 for:    klimberg and phase II

Analyzing the Composition of Tears to Identify Cancer (ACT)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Tenenbaum Family Foundation
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT00574678
First received: December 13, 2007
Last updated: January 24, 2014
Last verified: January 2014
  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.


Condition Intervention Phase
Breast Cancer
Ovarian Cancer
Colon Cancer
Benign Disease
Other: Tear collection
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: ACT: Analyzing the Composition of Tears to Identify Cancer (Breast, Ovarian, Colon)

Resource links provided by NLM:


Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: December 2006
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1 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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00574678

Locations
United States, Arkansas
University of Arkansas For Medical Sciences
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
Tenenbaum Family Foundation
Investigators
Principal Investigator: V. Suzanne Klimberg, MD University of Arkansas
  More Information

No publications provided

Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT00574678     History of Changes
Other Study ID Numbers: UAMS 71853
Study First Received: December 13, 2007
Last Updated: January 24, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of Arkansas:
Screening tool for cancer

Additional relevant MeSH terms:
Breast Neoplasms
Ovarian Neoplasms
Adnexal Diseases
Breast Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Skin Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on November 25, 2014