Trials / Unknown
UnknownNCT02178462
Biomarkers for Gynecologic Cancer
Evaluation of AminoIndex™ (Amino Metabolomic) As Biomarkers for Gynecologic Cancer in the U. S. Population
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 153 (actual)
- Sponsor
- Ajinomoto Co., Inc. · Industry
- Sex
- Female
- Age
- 20 Years – 80 Years
- Healthy volunteers
- Accepted
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).
Conditions
Timeline
- Start date
- 2014-06-01
- Primary completion
- 2018-03-01
- Completion
- 2018-03-01
- First posted
- 2014-06-30
- Last updated
- 2018-01-31
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02178462. Inclusion in this directory is not an endorsement.