How Our Immune System Can Help Fight Cancer

Ovarian Cancer Clinical Trial

Official title:

The Effect of Genetic Polymorphisms in Indoleamine 2, 3-Dioxygenase in Epithelial Ovarian Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01042847
• Other study ID #: 09316
• Status: Completed
• Phase: N/A
• First received: January 4, 2010
• Last updated: December 30, 2016
• Start date: January 2010
• Est. completion date: February 2015

Study information

• Verified date: December 2015
• Source: Winthrop University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 169
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 90 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Locations

Country	Name	City	State
United States	Winthrop-University Hospital	Mineola	New York

Sponsors (1)

Lead Sponsor	Collaborator
Winthrop University Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To examine the association of indoleamine 2,3-dioxygenase (IDO) genetic polymorphisms with clinical outcomes of ovarian cancer.		one year	No
Secondary	To correlate IDO activity with gene polymorphisms by measuring tryptophan/kynurenine ratios in the ascites of epithelial ovarian cancer patients.		one year	No