Brief Title
Biomarkers for Gynecologic Cancer
Official Title
Evaluation of AminoIndex™ (Amino Metabolomic) As Biomarkers for Gynecologic Cancer in the U. S. Population
Brief 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).
Study Type
Observational
Primary Outcome
Performance characteristics of AminoIndexTM biomarker to discriminate gynecologic cancer from benign disease or healthy subjects
Secondary Outcome
To identify and quantify new blood amino metabolic biomarkers that are associated with gynecologic cancer
Condition
Ovarian Cancer
Study Arms / Comparison Groups
Primary ovarian cancer patients
Description: Intervention will not be administered.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
153
Start Date
June 2014
Completion Date
March 2018
Primary Completion Date
March 2018
Eligibility Criteria
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
Gender
Female
Ages
20 Years - 80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
David O'Malley, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02178462
Organization ID
AI-2014-1
Responsible Party
Sponsor
Study Sponsor
Ajinomoto Co., Inc.
Collaborators
Ohio State University
Study Sponsor
David O'Malley, MD, Principal Investigator, Ohio State University
Verification Date
January 2018