Clinical trial · Observational
Evaluation of Multiple Biomarkers to Estimate Risk of Ovarian Cancer in Patients With a Pelvic Mass.
ANG-001 Pelvic Mass Training Study: Evaluation of Multiple Circulating Tumor Cell-derived RNA Markers to Estimate Risk of Ovarian Cancer in 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 for the differentiation of women with benign pelvic masses from those with malignant pelvic masses using mRNA markers extracted from CTCs isolated from whole blood. Multiple serum tumor markers and mRNA markers will be measured, and the results will be compared to the actual clinical diagnosis made for each patient through other recognized methods (e.g. histopathology). The blood samples collected in the course of this study will be used to finalize the selection of mRNA and/or serum tumor markers to be evaluated in future prospective studies. Exploratory Objective: Use statistical modeling to determine the need for and/or preliminary design of a mathematical algorithm to combine the multiple serum tumor and/or mRNA markers for estimation of the risk of ovarian cancer.
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 |
| laparotomy or laparoscopy | 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 (defined as a simple, complex or a solid ovarian cyst / pelvic mass) who are scheduled for a laparotomy or laparoscopy for removal of the pelvic mass. Must have a pelvic imaging study performed within 60 days prior to surgery and a research blood draw within 60 days prior to surgery.
- interventionNames
- Procedure: Pelvic imaging
- Procedure: Blood draw
- Procedure: laparotomy or laparoscopy
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 local institutional 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 laparotomy or laparoscopy based on the finding of a pelvic mass (defined as a simple, complex or a solid ovarian cyst / pelvic mass); * Willing and able to provide written informed consent prior to the blood collection. * Suitable venous access and healthy enough (as determined by the treating physician) to provide required whole blood sample. Exclusion Criteria: * Known pregnancy; * Subjects receiving cytotoxic chemotherapies; * 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 (2)
- 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