DNA Single Nucleotide Polymorphisms as Predictors of Toxicity

NCT02478476UNKNOWNOBSERVATIONAL

Summary

Key Facts

Lead Sponsor

OvaGene Oncology, Inc.

Enrollment

75

Start Date

2015-07-01

Completion Date

2016-12-01

Study Type

OBSERVATIONAL

Official Title

DNA Single Nucleotide Polymorphisms as Predictors of Platinum and Taxane Related Adverse Events in Ovarian, Fallopian Tube, and Peritoneal Cancer Patients

Conditions

Ovarian NeoplasmsFallopian Tube NeoplasmsPeritoneal Neoplasms

Eligibility

Age Range

18 Years+

Sex

FEMALE

Inclusion Criteria:

1. Female, greater than or equal to 18 years of age.
2. Must have pathologically confirmed ovarian, fallopian tube, or primary peritoneal cancer.
3. Able to provide a blood sample (3-5ml).
4. Planned course of therapy includes a platinum and/or taxane based chemotherapy.

Exclusion Criteria:

1. Has a clinically significant (per judgment of the PI) neurodegenerative, hematological, or cardiac related disease.
2. Has received prior chemotherapy.
3. Unable or unwilling to provide informed consent.

Outcome Measures

Primary Outcomes

Occurrence of chemotherapy related toxicities including Anemia, Nephrotoxicity, Neutropenia, Neuropathy, and Thrombocytopenia associated with genotype.

Specific genotypes will be evaluated as predictors of toxicity when patients receive platinum and/or taxane based chemotherapy.

Time frame: one year

Locations

Florida Hospital Cancer Institute, Orlando, United States