NCT02178462

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
153

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

June 23, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 30, 2014

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

January 31, 2018

Status Verified

January 1, 2018

Enrollment Period

3.8 years

First QC Date

June 23, 2014

Last Update Submit

January 29, 2018

Conditions

Ovarian CancerEndometrial CancerBenign Gynecological Disease

Outcome Measures

Primary Outcomes (1)

  • Performance characteristics of AminoIndexTM biomarker to discriminate gynecologic cancer from benign disease or healthy subjects

    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)

    Baseline

Secondary Outcomes (1)

  • To identify and quantify new blood amino metabolic biomarkers that are associated with gynecologic cancer

    Baseline

Study Arms (4)

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.

Eligibility Criteria

Age20 Years - 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Subject blood samples (plasma and serum) will be collected for testing at a single visit

MeSH Terms

Conditions

Ovarian NeoplasmsEndometrial Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersUterine NeoplasmsUterine Diseases

Study Officials

  • David O'Malley, MD

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2014

First Posted

June 30, 2014

Study Start

June 1, 2014

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

January 31, 2018

Record last verified: 2018-01

Locations

US(1)