Evaluation of Multiple Biomarkers to Estimate Risk of Ovarian Cancer in Patients With a Pelvic Mass.

NCT02785731 | Completed

• 1 other identifier: ANG-001
• Study Type: observational
• Target: 204
• Locations: 2 countries
• Sites: 5

Brief Summary

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

Ovarian Neoplasms

Keywords

pelvic mass; ovarian cancer; gynecological cancer; risk prediction

Outcome Measures

Primary Outcomes (3)

• Histopathological diagnosis

  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.

  Within 30 days after biopsy or surgical procedure to evaluate pelvic mass

• Presence or absence of circulating tumor cells

  Blood from EDTA tubes will be pooled and processed on the Parsortix System to capture and harvest rare cells. The captured rare cells will be eluted (harvested) and lysed, and total RNA will be extracted from the cell lysate for evaluation of multiple gene targets using quantitative PCR (qPCR).

  Up to 60 days prior to surgical procedure to evaluate pelvic mass

• Serum protein markers

  Serum from SST tube will be used for protein biomarker testing.

  Up to 60 days prior to surgical procedure to evaluate pelvic mass

Study Arms (1)

Women with a pelvic mass

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.

Procedure: Pelvic imaging; Procedure: Blood draw; Procedure: laparotomy or laparoscopy

Interventions

Pelvic imaging PROCEDURE

Within 60 days prior to the pelvic mass evaluation procedure, each subject must have a pelvic imaging study (e.g. ultrasound, CT scan, MRI, etc.) conducted and read to visualize the pelvic mass according to the current standard of care. Results of the pelvic imaging study(ies) will be recorded.

Also known as: pelvic ultrasound, CT scan, MRI scan

Women with a pelvic mass

Blood draw PROCEDURE

Within 60 days prior to, or on the day of the pelvic mass surgery, collect up to 35mL of whole blood into one 5mL SST tube, which must be drawn first, followed by three separate 10mL EDTA tubes.

Also known as: phlebotomy

Women with a pelvic mass

laparotomy or laparoscopy PROCEDURE

A laparotomy or laparoscopic procedure will be performed by a qualified individual for excision of the pelvic mass. Representative tissue samples will be taken from the excised pelvic mass and evaluated in pathology departments within each institution according to institutional guidelines. Results from the histopathological evaluation will be recorded, including the final diagnosis along with histological sub-type, and if available, stage and grade of cancer where disease is identified.

Women with a pelvic mass

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Angle plc: lead
• Medical University of Vienna: collaborator
• Charite University, Berlin, Germany: collaborator
• Vivantes Netzwerk für Gesundheit GmbH: collaborator

Study Sites (5)

Medical University of Vienna

Vienna, A-1090, Austria

Location

Vivantes Auguste-Viktoria-Klinikum

Berlin, 12157, Germany

Location

Vivantes-Klinikum Neukölln

Berlin, 12351, Germany

Location

Charité - Universitätsmedizin Berlin

Berlin, 13353, Germany

Location

Vivantes Humboldt-Klinikum

Berlin, 13509, Germany

Location

Related Publications (2)

• Obermayr 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 BACKGROUND

• Obermayr 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 BACKGROUND

Related Links

• Study Sponsor Website
• Charite Comprehensive Cancer Center Website
• Medical University of Vienna Website

Biospecimen

Retention: SAMPLES WITH DNA

All excess components (i.e. serum, plasma, RNA, DNA, cells, etc.) generated from the peripheral blood samples collected for research testing under this study be stored frozen at the Medical University of Vienna for up to 10 years for possible use in future research, including but not limited to, serum biomarker analyses, genomic evaluations and genetic studies pertaining to cancer and other disease processes.

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Magnetic Resonance Spectroscopy; Blood Specimen Collection; Phlebotomy; Laparotomy; Laparoscopy

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Therapeutics; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures

Study Officials

• Shane Booth, Ph.D.

  Angle plc

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2016
• First Posted: May 30, 2016
• Study Start: July 14, 2016
• Primary Completion: October 9, 2017
• Study Completion: July 31, 2018
• Last Updated: November 9, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); DE (4)