Biomarkers for Gynecologic Cancer

Status unconfirmed

Conditions studied: Ovarian Cancer, Endometrial Cancer, Benign Gynecological Disease

In brief

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.

Key facts

Study ID

NCT02178462

Run by

Ajinomoto Co., Inc.

People needed

153

Starts

2014-06-01

Expected to finish

2018-03-01

Last updated by the study team

2018-01-31

Who can join

Age: 20 and older, up to 80. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• The Ohio State University — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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