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

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ClinicalTrials.gov Identifier: NCT02785731
Recruitment Status : Completed
First Posted : May 30, 2016
Last Update Posted : November 9, 2018
Sponsor:
Collaborators:
Medical University of Vienna
Charite University, Berlin, Germany
Vivantes Netzwerk für Gesundheit GmbH
Information provided by (Responsible Party):
Angle plc

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.


Condition or disease Intervention/treatment
Ovarian Neoplasms Procedure: Pelvic imaging Procedure: Blood draw Procedure: laparotomy or laparoscopy

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 204 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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.
Actual Study Start Date : July 14, 2016
Actual Primary Completion Date : October 9, 2017
Actual Study Completion Date : July 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Group/Cohort Intervention/treatment
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
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.
Other Names:
  • pelvic ultrasound
  • CT scan
  • MRI scan

Procedure: Blood draw
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.
Other Name: phlebotomy

Procedure: laparotomy or laparoscopy
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.




Primary Outcome Measures :
  1. Histopathological diagnosis [ Time Frame: Within 30 days after biopsy or surgical procedure to evaluate pelvic mass ]
    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.

  2. Presence or absence of circulating tumor cells [ Time Frame: Up to 60 days prior to surgical procedure to evaluate pelvic mass ]
    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).

  3. Serum protein markers [ Time Frame: Up to 60 days prior to surgical procedure to evaluate pelvic mass ]
    Serum from SST tube will be used for protein biomarker testing.


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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02785731


Locations
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Austria
Medical University of Vienna
Vienna, Austria, A-1090
Germany
Vivantes Auguste-Viktoria-Klinikum
Berlin, Germany, 12157
Vivantes-Klinikum Neukölln
Berlin, Germany, 12351
Charité - Universitätsmedizin Berlin
Berlin, Germany, 13353
Vivantes Humboldt-Klinikum
Berlin, Germany, 13509
Sponsors and Collaborators
Angle plc
Medical University of Vienna
Charite University, Berlin, Germany
Vivantes Netzwerk für Gesundheit GmbH
Investigators
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Study Director: Shane Booth, Ph.D. Angle plc

Additional Information:
Publications:
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Responsible Party: Angle plc
ClinicalTrials.gov Identifier: NCT02785731     History of Changes
Other Study ID Numbers: ANG-001
First Posted: May 30, 2016    Key Record Dates
Last Update Posted: November 9, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Angle plc:
pelvic mass
ovarian cancer
gynecological cancer
risk prediction

Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type