Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

How Our Immune System Can Help Fight Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2010 by Winthrop University Hospital.
Recruitment status was:  Not yet recruiting
Information provided by:
Winthrop University Hospital Identifier:
First received: January 4, 2010
Last updated: January 5, 2010
Last verified: January 2010

There is growing evidence that our immune system can help fight cancer. This has stimulated interest in the development and application of tumor vaccines for several human solid tumors, including epithelial ovarian cancer (EOC). A major obstacle to the development of these vaccines is that there are specialty cells called regulatory T cells that prevent the immune system from attacking all of our organs. These regulatory T cells also prevent our immune system for attacking cancer cells.

Indoleamine 2,3-dioxygenase (IDO), an enzyme that degrades an essential amino acid tryptophan that is necessary for T cells to multiply, however regulatory T cells are less susceptible to low levels of tryptophan, and can still multiply. This allows cancer growth and progression. This may be explained by genetic polymorphisms (changes) in the IDO gene, which may alter its function. Five of these changes in the IDO gene have been described. In this research project, we are asking if you would donate a small piece of your tumor and ascites to see if we can examine your IDO gene in the tumor cells and see if any of these gene changes are present. We hope that this will help us understand how the immune system works in EOC.

We hypothesize that genetic polymorphisms within the IDO gene alter its enzymatic activity and affect the outcome of ovarian cancer patients. These findings have the potential to translate into a method for predicting successful immunotherapy.

Ovarian Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Effect of Genetic Polymorphisms in Indoleamine 2, 3-Dioxygenase in Epithelial Ovarian Cancer

Resource links provided by NLM:

Further study details as provided by Winthrop University Hospital:

Primary Outcome Measures:
  • To examine the association of indoleamine 2,3-dioxygenase (IDO) genetic polymorphisms with clinical outcomes of ovarian cancer. [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To correlate IDO activity with gene polymorphisms by measuring tryptophan/kynurenine ratios in the ascites of epithelial ovarian cancer patients. [ Time Frame: one year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA
surgical tissue ascites fluid

Estimated Enrollment: 100
Study Start Date: January 2010
Estimated Study Completion Date: January 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   20 Years to 90 Years   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with histologically confirmed epithelial ovarian cancer (EOC) who have had surgical resection as primary therapy for their disease will be included in this study.

Inclusion Criteria:

  • females aged 20-90 who are having surgery to confirm epithelial ovarian cancer.

Exclusion Criteria:

  • patients who have a diagnosis of non-epithelial histology.
  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 identifier: NCT01042847

United States, New York
Winthrop-University Hospital
Mineola, New York, United States, 11501
Sponsors and Collaborators
Winthrop University Hospital
Principal Investigator: Jeannine A Villella, D.O. Winthrop University Hospital
  More Information

Responsible Party: Jeannine Villella, D.O., Winthrop-University Hospital Identifier: NCT01042847     History of Changes
Other Study ID Numbers: 09316 
Study First Received: January 4, 2010
Last Updated: January 5, 2010
Health Authority: United States: Federal Government

Keywords provided by Winthrop University Hospital:

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders processed this record on December 09, 2016