Evaluation of Multiple Protein and Molecular Biomarkers to Estimate Risk of Cancer in Gynecology Patients Presenting With a Pelvic Mass.
Public ClinicalTrials.gov record NCT02781272. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
ANG-003 EMBER Study: Evaluation of Multiple Protein and Molecular Biomarkers to Estimate Risk of Cancer in Gynecology Patients Presenting With a Pelvic Mass.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
ANGLE has developed the Parsortix™ Cell Separation System (Parsortix), an automated system capable of harvesting rare circulating cells for analysis from a sample of peripheral blood based on cellular size and deformability. In a small pilot study, scientists at the Medical University of Vienna demonstrated that measurement of a combination of mRNA markers extracted from CTCs captured using the Parsortix system could be used to identify women with ovarian cancer. This study is designed to provide specimens for optimization of an assay using clinical and biomarker information (i.e. demographics, imaging results and/or serum tumor markers) in combination with mRNA extracted from rare cells in the blood of women presenting with a pelvic mass for the detection of malignancy. Primary Objective: Optimization of an assay/algorithm for the differentiation of women with benign pelvic masses from those with malignant pelvic masses using clinical and biomarker information (i.e. demographics, imaging results and/or serum tumor markers) in combination with mRNA markers extracted from rare cells isolated from whole blood. Multiple serum protein markers and mRNA markers will be measured, and the results will be compared to the actual clinical diagnosis made for each subject through other recognized methods (i.e. histopathology). Statistical modeling will be used to combine the clinical information, serum protein markers and/or mRNA markers for estimation of the risk of malignancy. If successful, the resulting risk algorithm will be evaluated in future, appropriately powered, prospective studies. Exploratory Objective: Use statistical modeling to determine the need for and/or preliminary design of a mathematical algorithm to combine the clinical information, serum protein markers and/or mRNA markers for estimation of the risk of malignancy.
Study identification
- NCT ID
- NCT02781272
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 200 participants
Conditions and interventions
Conditions
Interventions
- Pelvic imaging Procedure
- Blood draw Procedure
- Imaging guided biopsy, surgical biopsy or surgical excision Procedure
Procedure
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 29, 2016
- Primary completion
- May 31, 2017
- Completion
- Jun 26, 2022
- Last update posted
- Jun 4, 2023
2016 – 2022
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Rochester Medical Center Wilmot Cancer Institute | Rochester | New York | 14642 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Recently updated Ovarian Neoplasms trials
Other public records listing Ovarian Neoplasms. Sorted by last update posted; newest first. Not a recommendation.
- NCT07764744: Ovarian Cancer Liquid Biopsy for Early Assessment & Detection in Individuals With BRCA1/2 Pathogenic Variants Not yet recruiting
- NCT07038369: A Phase 1 Study of ATV-1601 in Patients With Advanced Cancer That Have AKT1 E17K Mutations Active, not recruiting
- NCT06751329: A Study of DM002 in Patients With Advanced Solid Tumors Recruiting
- NCT04641247: A Long-term Treatment Extension Study of Niraparib in Participants Who Completed a Prior GlaxoSmithKline/TESARO-sponsored Niraparib Study Recruiting
- NCT06543537: Pilot Randomized Controlled Trial of a Collaborative Agenda-setting Intervention (CASI) for Patients With Ovarian Cancer Recruiting
- NCT06051695: A Study to Evaluate the Safety and Efficacy of Mesothelin-Targeting Logic-gated CAR T, in Participants With Solid Tumors That Express MSLN and Have Lost HLA-A*02 Expression Recruiting
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02781272, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 4, 2023 · Synced Sep 7, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02781272 live on ClinicalTrials.gov.