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Evaluation of Multiple Protein and Molecular Biomarkers to Estimate Risk of Cancer in Gynecology Patients Presenting With a Pelvic Mass. (EMBER)

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ClinicalTrials.gov Identifier: NCT02781272
Recruitment Status : Active, not recruiting
First Posted : May 24, 2016
Last Update Posted : October 5, 2020
Sponsor:
Collaborator:
University of Rochester
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/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.


Condition or disease Intervention/treatment
Ovarian Neoplasms Procedure: Pelvic imaging Procedure: Blood draw Procedure: Imaging guided biopsy, surgical biopsy or surgical excision

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Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
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.
Actual Study Start Date : June 30, 2016
Actual Primary Completion Date : June 1, 2017
Estimated Study Completion Date : June 30, 2022

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 (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.
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 30 days prior to, or on the day of the pelvic mass evaluation procedure, 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: Imaging guided biopsy, surgical biopsy or surgical excision
Imaging guided biopsy, surgical biopsy or surgical excision for evaluation of the pelvic mass will be performed by a qualified individual. Tissue samples will be sent to the local pathology department for histological examination in accordance with standard institutional practices. Results of 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 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.

  2. Presence or absence of circulating tumor cells [ Time Frame: Up to 30 days prior to biopsy or 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.

  3. Serum protein markers [ Time Frame: Up to 30 days prior to biopsy or surgical procedure to evaluate pelvic mass ]
    Serum from SST tube will be used for protein biomarker testing.


Other Outcome Measures:
  1. Treatment response [ Time Frame: Up to 5 years after enrollment ]
    For subjects diagnosed with a malignancy, a bi-annual medical record review will be performed for up to 5 years after their enrollment into the study to collect information regarding their treatment response, chemotherapy sensitivity and resistance, time to recurrence, time to progression and overall survival.

  2. Disease recurrence or progression [ Time Frame: Up to 5 years after enrollment ]
    For subjects diagnosed with a malignancy, a bi-annual medical record review will be performed for up to 5 years after their enrollment into the study to collect information regarding their treatment response, chemotherapy sensitivity and resistance, time to recurrence, time to progression and overall survival.

  3. Overall survival [ Time Frame: Up to 5 years after enrollment ]
    For subjects diagnosed with a malignancy, a bi-annual medical record review will be performed for up to 5 years after their enrollment into the study to collect information regarding their treatment response, chemotherapy sensitivity and resistance, time to recurrence, time to progression and overall survival.


Biospecimen Retention:   Samples With DNA
All excess components (i.e. serum, RNA, DNA, cells, etc.) generated from the whole blood and tissue samples collected for research testing, as well as any remaining tissue samples collected under this study, will be stored frozen at the Targeted Therapeutics Laboratory at the Wilmot Cancer Institute indefinitely for possible use in future research, including but not limited to, 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 (ovarian, uterine, retroperitoneal, etc.) who are scheduled for an imaging guided biopsy, surgical biopsy or surgical excision for evaluation of their pelvic mass.
Criteria

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.

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): NCT02781272


Locations
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United States, New York
University of Rochester Medical Center Wilmot Cancer Institute
Rochester, New York, United States, 14642
Sponsors and Collaborators
Angle plc
University of Rochester
Investigators
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Principal Investigator: Richard G Moore, MD University of Rochester
Additional Information:
Publications:
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Responsible Party: Angle plc
ClinicalTrials.gov Identifier: NCT02781272    
Other Study ID Numbers: ANG-003
First Posted: May 24, 2016    Key Record Dates
Last Update Posted: October 5, 2020
Last Verified: October 2020
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
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders