DNA Single Nucleotide Polymorphisms as Predictors of Toxicity

Status unconfirmed

Conditions studied: Ovarian Neoplasms, Fallopian Tube Neoplasms, Peritoneal Neoplasms

In brief

The presence of single nucleotide polymorphisms (SNPs) in genes involved in platinum and taxane metabolism and detoxification have been correlated to increased risk of severe adverse events (AEs) when patients receive these drugs. The investigators propose studies to validate a comprehensive panel of twelve SNPs in ovarian cancer patients that may predict AEs when treated with therapies that include platinum and taxanes. Using these results to stratify patients to different dosing regimens, routes of administration, or in recurrent cancer to aid in drug selection, may improve outcome and reduce costs for the management of drug related side effects while not changing standard of care. Since these differences can be detected from blood, the determination of genotypes can be done using a standard blood sample taken after ovarian cancer is confirmed on the patient's pathology report. These genetic differences can be detected by QPCR and Next Generation Sequencing.

Key facts

Study ID

NCT02478476

Run by

OvaGene Oncology, Inc.

People needed

75

Starts

2015-07-01

Expected to finish

2017-12-01

Last updated by the study team

2015-06-23

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• Florida Hospital Cancer Institute — Orlando, Florida, United States

Full record on ClinicalTrials.gov

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