dermoid_cyst: Paraneoplastic Neurologic Encephalitis and Mature Cystic Teratoma

Sponsor
Assaf-Harofeh Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05223543
Collaborator
(none)
60
1
33.9
1.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Blood sample

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 Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
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
Actual Study Start Date :
Jan 1, 2020
Anticipated Primary Completion Date :
Oct 30, 2022
Anticipated Study Completion Date :
Oct 30, 2022

Outcome Measures

Primary Outcome Measures

  1. prevalence of NMDA receptor antibodies [baseline, pre-surgery]

    to identify the prevalence of antibodies and titer in the presence of ovarian dermoid cyst in neurology asymptomatic patients

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 50 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shamir medical center Rishon LeZion Israel Zrifin

Sponsors and Collaborators

  • Assaf-Harofeh Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Assaf Harofeh MC, Noam Smorgick MD, Director of Minimally Invasive Gynecology, Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:
NCT05223543
Other Study ID Numbers:
  • 0194-18
  • 0194-18
First Posted:
Feb 4, 2022
Last Update Posted:
Feb 4, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 4, 2022