Biomarkers for Gynecologic Cancer

Ajinomoto

Status

Unknown

Conditions

Endometrial Cancer

Benign Gynecological Disease

Ovarian Cancer

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT02178462

AI-2014-1

Details and patient eligibility

About

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.

Full 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).

Enrollment

153 patients

Sex

Female

Ages

20 to 80 years old

Volunteers

Accepts Healthy Volunteers

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