Clinical trial · Observational
Biomarkers for Gynecologic Cancer
Evaluation of AminoIndex™ (Amino Metabolomic) As Biomarkers for Gynecologic Cancer in the U. S. Population
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Benign Gynecological Disease | — | UNRESOLVED | — |
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (4)
- label
- Primary ovarian cancer patients
- description
- Intervention will not be administered.
- label
- Primary endometrial cancer patients
- description
- Intervention will not be administered.
- label
- Benign gynecological disease patients
- description
- Intervention will not be administered.
- label
- Healthy controls
- description
- Intervention will not be administered.
Primary outcomes (1)
- measure
- Performance characteristics of AminoIndexTM biomarker to discriminate gynecologic cancer from benign disease or healthy subjects
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available