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

NCT02781272 | Completed

• 1 other identifier: ANG-003
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

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 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.

  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.

  Up to 30 days prior to biopsy or surgical procedure to evaluate pelvic mass

• Serum protein markers

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

  Up to 30 days prior to biopsy or surgical procedure to evaluate pelvic mass

Other Outcomes (3)

• Treatment response

  Up to 5 years after enrollment

• Disease recurrence or progression

  Up to 5 years after enrollment

• Overall survival

  Up to 5 years after enrollment

Study Arms (1)

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; Procedure: Blood draw; Procedure: Imaging guided biopsy, surgical biopsy or surgical excision

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 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.

Also known as: phlebotomy

Women with a pelvic mass

Imaging guided biopsy, surgical biopsy or surgical excision PROCEDURE

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.

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 (ovarian, uterine, retroperitoneal, etc.) who are scheduled for an imaging guided biopsy, surgical biopsy or surgical excision for evaluation of their pelvic mass.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Angle plc: lead
• University of Rochester: collaborator

Study Sites (1)

University of Rochester Medical Center Wilmot Cancer Institute

Rochester, New York, 14642, United States

Location

Related Publications (3)

• 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

• Moore 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 RESULT

Related Links

• Study Sponsor Website
• University of Rochester Medical Center Wilmot Cancer Institute Website
• 49th SGO Annual Meeting on Women's Cancer, March 24-27, 2018, Abstract Citation

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.

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Magnetic Resonance Spectroscopy; Blood Specimen Collection; Phlebotomy; Image-Guided Biopsy

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; Biopsy; Cytodiagnosis; Cytological Techniques; Diagnostic Techniques, Surgical

Study Officials

• Richard G Moore, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 20, 2016
• First Posted: May 24, 2016
• Study Start: June 30, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 27, 2022
• Last Updated: June 5, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)