Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
153 participants
OBSERVATIONAL
2014-06-30
2018-03-31
Brief Summary
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Detailed Description
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This study wil be conducted to evaluate the performance of AminoIndexTM (gynecological) biomarker based on "AminoIndex Technology" for gynecological cancers in US populations. This will be done by analyzing plasma metabolites including amino acids, from endometrial and ovarian cancer patients, from patients with benign gynecological disease, and healthy subjects using Liquid Chromatography and Mass Spectrometry (LC-MS) and Liquid Chromatography - Tandem Mass Spectrometry (LC-MSMS).
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Primary ovarian cancer patients
Intervention will not be administered.
No interventions assigned to this group
Primary endometrial cancer patients
Intervention will not be administered.
No interventions assigned to this group
Benign gynecological disease patients
Intervention will not be administered.
No interventions assigned to this group
Healthy controls
Intervention will not be administered.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Age \> 20 years (no data is currently available on use of AminoIndexTM in patients under 20 years of age or over 80 years of age)
* Willing to follow fasting and clinic visit requirements
* Ability to understand and consent to participate in study.
Women of all races and ethnic groups are eligible for this trial.
Exclusion Criteria
* An inability to fast (no food or drink other than water) for 8 hours prior to the pre-surgery sample collection.
* Are known to be positive for HIV/HCV/HBV
* Pregnancy or breastfeeding (Pregnant and breastfeeding women are excluded from this study because amino acid levels are known to differ in pregnancy).
* Currently receiving investigational agents.
* History of any drug therapy or surgery for treatment of gynecological cancer
* Unable to come for the blood sample collection between 6:00 AM and 12:00 Noon
* Currently undergoing dialysis
* Congenital metabolic disease
* The investigator considers individual to be ineligible based on prior medical history, histology or other findings
20 Years
80 Years
FEMALE
Yes
Sponsors
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Ohio State University
OTHER
Ajinomoto Co., Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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David O'Malley, MD
Role: PRINCIPAL_INVESTIGATOR
Ohio State University
Locations
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The Ohio State University
Columbus, Ohio, United States
Countries
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Other Identifiers
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AI-2014-1
Identifier Type: -
Identifier Source: org_study_id
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