Clinical trial · Observational
Evaluation of Multiple Protein and Molecular Biomarkers to Estimate Risk of Cancer in Gynecology Patients Presenting With a Pelvic Mass.
ANG-003 EMBER Study: Evaluation of Multiple Protein and Molecular Biomarkers to Estimate Risk of Cancer in Gynecology Patients Presenting With a Pelvic Mass.
- 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)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Neoplasms | Ovarian Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood draw | Procedure | — | UNRESOLVED |
| Imaging guided biopsy, surgical biopsy or surgical excision | Procedure | — | UNRESOLVED |
| Pelvic imaging | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Women with a pelvic mass
- description
- Women diagnosed with a pelvic mass (ovarian, uterine, retroperitoneal, etc.) who are scheduled for an imaging guided biopsy, surgical biopsy or surgical excision for evaluation of their pelvic mass. Must have a pelvic imaging study performed within 60 days prior to surgery and a research blood draw within 30 days prior to surgery.
- interventionNames
- Procedure: Pelvic imaging
- Procedure: Blood draw
- Procedure: Imaging guided biopsy, surgical biopsy or surgical excision
Primary outcomes (3)
- measure
- Histopathological diagnosis
- timeFrame
- Within 30 days after biopsy or surgical procedure to evaluate pelvic mass
- description
- Tissue samples taken from the pelvic mass will be evaluated in the URMC GYN pathology department according to institutional guidelines. Results from the histopathological evaluation, including the final diagnosis (i.e. benign, malignant, etc.), histopathology description, and, if malignant, clinical or surgical staging and tumor subtype, will be recorded.
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women \>18 years of age; * Documented evidence of a pelvic mass by imaging; * Selected to undergo biopsy, laparotomy or laparoscopy for pathologic evaluation of their pelvic mass; * Willing and able to provide written informed consent. Exclusion Criteria: * Known pregnancy; * Previous malignancy within the past 5 years, excluding skin cancers (squamous cell or basal cell); * Unwilling or unable to follow protocol requirements or to provide informed consent.
References
Publications (3)
- BACKGROUNDObermayr E, Castillo-Tong DC, Pils D, Speiser P, Braicu I, Van Gorp T, Mahner S, Sehouli J, Vergote I, Zeillinger R. Molecular characterization of circulating tumor cells in patients with ovarian cancer improves their prognostic significance -- a study of the OVCAD consortium. Gynecol Oncol. 2013 Jan;128(1):15-21. doi: 10.1016/j.ygyno.2012.09.021. Epub 2012 Sep 24. PMID 23017820
- BACKGROUNDObermayr E, Sanchez-Cabo F, Tea MK, Singer CF, Krainer M, Fischer MB, Sehouli J, Reinthaller A, Horvat R, Heinze G, Tong D, Zeillinger R. Assessment of a six gene panel for the molecular detection of circulating tumor cells in the blood of female cancer patients. BMC Cancer. 2010 Dec 3;10:666. doi: 10.1186/1471-2407-10-666. PMID 21129172
- RESULTMoore RG, Khazan N, Coulter MA, Singh R, Miller MC, Sivagnanalingam U, DuBeshter B, Angel C, Liu C, Seto K, Englert D, Meachem P, Kim KK. Malignancy Assessment Using Gene Identification in Captured Cells Algorithm for the Prediction of Malignancy in Women With a Pelvic Mass. Obstet Gynecol. 2022 Oct 1;140(4):631-642. doi: 10.1097/AOG.0000000000004927. Epub 2022 Sep 7. PMID 36075062