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DNA Single Nucleotide Polymorphisms as Predictors of Toxicity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02478476
Recruitment Status : Unknown
Verified June 2015 by OvaGene Oncology, Inc..
Recruitment status was:  Not yet recruiting
First Posted : June 23, 2015
Last Update Posted : June 23, 2015
Sponsor:
Information provided by (Responsible Party):
OvaGene Oncology, Inc.

Brief Summary:
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.

Condition or disease
Ovarian Neoplasms Fallopian Tube Neoplasms Peritoneal Neoplasms

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Study Type : Observational
Estimated Enrollment : 75 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: DNA Single Nucleotide Polymorphisms as Predictors of Platinum and Taxane Related Adverse Events in Ovarian, Fallopian Tube, and Peritoneal Cancer Patients
Study Start Date : July 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Occurrence of chemotherapy related toxicities including Anemia, Nephrotoxicity, Neutropenia, Neuropathy, and Thrombocytopenia associated with genotype. [ Time Frame: one year ]
    Specific genotypes will be evaluated as predictors of toxicity when patients receive platinum and/or taxane based chemotherapy.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with pathologically confirmed ovarian, fallopian tube, or peritoneal cancer scheduled to receive platinum and/or taxane based chemotherapy.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02478476


Contacts
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Contact: Robert W Holloway, MD (407)303-2422

Locations
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United States, Florida
Florida Hospital Cancer Institute
Orlando, Florida, United States, 32804
Contact: Robert W Holloway, MD    407-303-2422      
Sponsors and Collaborators
OvaGene Oncology, Inc.
Investigators
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Study Director: William Ricketts, PhD OvaGene Oncology
Publications:
Paclitaxel, [package insert], Bristol-Meyers Squibb Company, Princeton, NJ, April 2011.
Chemotherapy procedure Manual, Gynecologic Oncology Group, January 2004.

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Responsible Party: OvaGene Oncology, Inc.
ClinicalTrials.gov Identifier: NCT02478476    
Other Study ID Numbers: IRBNet#673096
First Posted: June 23, 2015    Key Record Dates
Last Update Posted: June 23, 2015
Last Verified: June 2015
Additional relevant MeSH terms:
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Neoplasms
Ovarian Neoplasms
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Fallopian Tube Diseases