Paraneoplastic Neurologic Encephalitis and Mature Cystic Teratoma (dermoid_cyst)

January 23, 2022 updated by: Assaf Harofeh MC, Assaf-Harofeh Medical Center

The Presence of N-Methyl-D-Aspartic Acid Receptor (NMDA-R) Antibodies in Serums of Women With Pathology Proven Dermoid Cyst and Examining the Relationship of Cyst Characteristics

Ovarian dermoid cyst, also known as benign mature teratoma, originate from germ cells in the ovary, and is the most common benign ovarian tumor (44-70%). Several reports documented a secretion of NMDA receptor antibodies from dermoid cyst. This receptor is found in different areas in the central nerves system (CNS) and the presence of plasma antibodies has been shown as a rare cause of neurologic presentation term paraneoplastic neurologic syndrome, which can be characterized by mood disorder, psychiatric and neurologic symptoms. In several case reports on young women, first presented with nonspecific neurologic symptoms, then followed by rapid deterioration of conscious, seizures and the need for ventilation support, ovarian teratoma was diagnosed. In 2007 an association between N-Methyl-D-Aspartic acid (NMDA) receptor antibody and encephalitis was first described. More than 50% of paraneoplastic encephalitis were related to teratomas, most often from an ovarian origin. Therapy includes tumor resection, steroids, plasmapheresis and immunosuppressive drugs. The investigators recently published a retrospective cohort study analyzing 233 patients who were operated in their institution with pathology proven dermoid. In this study 2 patients presented with paraneoplastic syndrome (0.85%). No prospective study has been published to date to examine the association between antibody titer and dermoid cyst characteristics and the paraneoplastic phenomenon. The investigators wish to conduct a prospective study in which plasma samples will be obtained from patients asymptomatic for neurologic or psychiatric symptoms, undergoing surgery for ovarian dermoid cyst, due to gynecology indication (e.g size, symptoms) in order to identify antibodies against CNS NMDA-R in their plasma prior to cyst removal. If NMDA receptor antibodies will be discovered in asymptomatic patients it may be prudent to examine all serums of women who are diagnosed with ovarian mature teratoma, and offer a surgical removal in order to prevent a possible neurologic sequela in the presence of these antibodies.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The data is collected by examining women's serum for the presence of NMDA-R antibodies, using special ELISA (enzyme-linked immunoabsorbent assay) kits. The analysis will be made by Dyn diagnostics labs. The investigators will obtain a blood sample prior to the operation for cystectomy or oophorectomy and after a written informed consent by the patient. All specimen are sent to pathology examination and only proven dermoid cyst will eventually be enrolled.

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Israel
      • Rishon LeZion, Israel, Zrifin
        • Recruiting
        • Shamir Medical Center
        • Contact:
          • Hilli
          • Phone Number: 0508334458

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

women in reproductive years undergoing cystectomy or oopherectomy due to suspected ovarian dermoid cyst

Description

Inclusion Criteria:

  1. Women admitted for surgery for removal of suspected dermoid cysts
  2. No neurologic symptoms

Exclusion Criteria:

  1. No surgical specimen available
  2. The cyst pathology does not show dermoid cyst characteristics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
prevalence of NMDA receptor antibodies
Time Frame: baseline, pre-surgery
to identify the prevalence of antibodies and titer in the presence of ovarian dermoid cyst in neurology asymptomatic patients
baseline, pre-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assaf-Harofeh Medical Center

Investigators

  • Study Director: Noam Smorgick, M.D, Shamir Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2020

Primary Completion (ANTICIPATED)

October 30, 2022

Study Completion (ANTICIPATED)

October 30, 2022

Study Registration Dates

First Submitted

September 12, 2021

First Submitted That Met QC Criteria

January 23, 2022

First Posted (ACTUAL)

February 4, 2022

Study Record Updates

Last Update Posted (ACTUAL)

February 4, 2022

Last Update Submitted That Met QC Criteria

January 23, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0194-18 (OTHER: Shamir medical center)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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