Clinical trial NCT02178462: Biomarkers for Gynecologic Cancer
Official title: Evaluation of AminoIndex™ (Amino Metabolomic) As Biomarkers for Gynecologic Cancer in the U. S. Population
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ovarian Cancer
Endometrial Cancer
Benign Gynecological Disease
Lead sponsor: Ajinomoto Co., Inc.
Sponsor class: INDUSTRY
Collaborators: name: Ohio State University
First posted: 2014-06-30
Enrollment: 153
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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 eligibility criteria:

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).

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

Primary outcomes:
measure: Performance characteristics of AminoIndexTM biomarker to discriminate gynecologic cancer from benign disease or healthy subjects
timeFrame: Baseline
Secondary outcomes:
measure: To identify and quantify new blood amino metabolic biomarkers that are associated with gynecologic cancer
timeFrame: Baseline
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: David O'Malley, MD
role: PRINCIPAL_INVESTIGATOR
References: