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Biomarkers for Gynecologic Cancer | Clinical Trials | Clareo Health

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Biomarkers for Gynecologic Cancer

Evaluation of AminoIndex™ (Amino Metabolomic) As Biomarkers for Gynecologic Cancer in the U. S. Population

NCT02178462•Ajinomoto Co., Inc.

Summary

A novel blood metabolic biomarker, AminoIndexTM (gynecological), was developed for gynecological cancers from over 400 Japanese patient's plasma free amino acid profiles (PFAAs) by a rapid and sensitive LC-MS (Liquid Chromatography - Mass Spectrometry), followed by multivariate statistical analyses. However, further studies to assess whether this biomarker demonstrates the same performance characteristics in non-Japanese populations for cancer is yet to be determined.

Detailed Description

"AminoIndex Technology" was developed based on high-throughput and absolute quantitative analysis method of amino acids and amines using UFLC-MS, and creating a clinical database to search for amino acid patterns across different diseases including cancer. "AminoIndex Technology" can evaluate certain health conditions and the possibility of diseases by analyzing the balance of plasma amino acids. Multicenter studies in Japan were conducted to develop an blood based biomarker panel for cancer. 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).

Eligibility

Age

20 - 80 years

Sex

FEMALE

Healthy Volunteers

Yes

Inclusion Criteria

•Participants in this study will be patients with Primary endometrial and ovarian cancer, benign gynecological diseases (such as uterine fibroids, endometriosis, dysplasia, and benign ovarian tumors), and healthy subjects that meet the following 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

•Women will be excluded from study participation for the following reasons:
•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

Locations (1)

The Ohio State University

Columbus, Ohio, United States

Key Dates

Start Date

June 1, 2014

Primary Completion Date

March 1, 2018

Completion Date

March 1, 2018

Last Updated

January 31, 2018

Enrollment

153

ACTUAL participants

Conditions

Ovarian CancerEndometrial CancerBenign Gynecological Disease

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 31, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Biomarkers for Gynecologic Cancer

Inclusion Criteria

Exclusion Criteria

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