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Biomarkers for Gynecologic Cancer

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ClinicalTrials.gov Identifier: NCT02178462
Recruitment Status : Active, not recruiting
First Posted : June 30, 2014
Last Update Posted : January 31, 2018
Sponsor:
Collaborator:
Ohio State University
Information provided by (Responsible Party):
Ajinomoto Co., Inc.

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.

Condition or disease
Ovarian Cancer Endometrial Cancer Benign Gynecological Disease

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
Actual Enrollment : 153 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Evaluation of AminoIndex™ (Amino Metabolomic) As Biomarkers for Gynecologic Cancer in the U. S. Population
Study Start Date : June 2014
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


Group/Cohort
Primary ovarian cancer patients
Intervention will not be administered.
Primary endometrial cancer patients
Intervention will not be administered.
Benign gynecological disease patients
Intervention will not be administered.
Healthy controls
Intervention will not be administered.



Primary Outcome Measures :
  1. Performance characteristics of AminoIndexTM biomarker to discriminate gynecologic cancer from benign disease or healthy subjects [ Time Frame: Baseline ]
    Performance characteristics of the AminoIndexTM biomarker will be evaluated by analyzing blood and comparing results between cancer patients, benign gynecological diseases, and healthy subjects. (AUC of the ROC curve, sensitivity, specificity, and other measures of performance)


Secondary Outcome Measures :
  1. To identify and quantify new blood amino metabolic biomarkers that are associated with gynecologic cancer [ Time Frame: Baseline ]
    Blood will be examined for new blood amino metabolic biomarkers and their concentrations will be compared between cancer patients and benign disease patients and healthy subjects


Biospecimen Retention:   Samples Without DNA
Subject blood samples (plasma and serum) will be collected for testing at a single visit


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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:
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02178462


Locations
United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ajinomoto Co., Inc.
Ohio State University
Investigators
Principal Investigator: David O'Malley, MD Ohio State University

Responsible Party: Ajinomoto Co., Inc.
ClinicalTrials.gov Identifier: NCT02178462     History of Changes
Other Study ID Numbers: AI-2014-1
First Posted: June 30, 2014    Key Record Dates
Last Update Posted: January 31, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Endometrial Neoplasms
Genital Diseases, Female
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases