- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01042847
How Our Immune System Can Help Fight Cancer
The Effect of Genetic Polymorphisms in Indoleamine 2, 3-Dioxygenase in Epithelial Ovarian Cancer
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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New York
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Mineola, New York, United States, 11501
- Winthrop-University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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To examine the association of indoleamine 2,3-dioxygenase (IDO) genetic polymorphisms with clinical outcomes of ovarian cancer.
Time Frame: one year
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one year
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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To correlate IDO activity with gene polymorphisms by measuring tryptophan/kynurenine ratios in the ascites of epithelial ovarian cancer patients.
Time Frame: one year
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one year
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jeannine A Villella, D.O., Winthrop University Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Ovarian Neoplasms
- Carcinoma, Ovarian Epithelial
Other Study ID Numbers
- 09316
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