Paraneoplastic Neurologic Encephalitis and Mature Cystic Teratoma

NCT05223543 | Unknown

• 1 other identifier: 0194-18
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Dermoid Cyst

Outcome Measures

Primary Outcomes (1)

• prevalence of NMDA receptor antibodies

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

  baseline, pre-surgery

Interventions

Blood sample DIAGNOSTIC_TEST

extraction of blood samples from women undergoing ovarian cystectomy or oophorectomy due to suspected Dermoid cyst and analysing plasma for antibodies

Eligibility Criteria

• Age: 20 Years - 50 Years
• Gender Eligibility Details: women in reproductive years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Women admitted for surgery for removal of suspected dermoid cysts
• No neurologic symptoms

You may not qualify if:

• No surgical specimen available
• The cyst pathology does not show dermoid cyst characteristics

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead

Study Sites (1)

Shamir medical center

Rishon LeZiyyon, Zrifin, Israel

RECRUITING

Related Publications (6)

• Ayhan A, Bukulmez O, Genc C, Karamursel BS, Ayhan A. Mature cystic teratomas of the ovary: case series from one institution over 34 years. Eur J Obstet Gynecol Reprod Biol. 2000 Feb;88(2):153-7. doi: 10.1016/s0301-2115(99)00141-4.

  PMID: 10690674 BACKGROUND

• Dalmau J, Gleichman AJ, Hughes EG, Rossi JE, Peng X, Lai M, Dessain SK, Rosenfeld MR, Balice-Gordon R, Lynch DR. Anti-NMDA-receptor encephalitis: case series and analysis of the effects of antibodies. Lancet Neurol. 2008 Dec;7(12):1091-8. doi: 10.1016/S1474-4422(08)70224-2. Epub 2008 Oct 11.

  PMID: 18851928 BACKGROUND

• Vitaliani R, Mason W, Ances B, Zwerdling T, Jiang Z, Dalmau J. Paraneoplastic encephalitis, psychiatric symptoms, and hypoventilation in ovarian teratoma. Ann Neurol. 2005 Oct;58(4):594-604. doi: 10.1002/ana.20614.

  PMID: 16178029 BACKGROUND

• Dalmau J, Tuzun E, Wu HY, Masjuan J, Rossi JE, Voloschin A, Baehring JM, Shimazaki H, Koide R, King D, Mason W, Sansing LH, Dichter MA, Rosenfeld MR, Lynch DR. Paraneoplastic anti-N-methyl-D-aspartate receptor encephalitis associated with ovarian teratoma. Ann Neurol. 2007 Jan;61(1):25-36. doi: 10.1002/ana.21050.

  PMID: 17262855 BACKGROUND

• Li W, Jia D, Tong L, Lun Z, Li H. Anti-N-methyl-D-aspartate receptor encephalitis induced by bilateral ovarian teratomas with distinct histopathologic types: A case report and brief literature review. Medicine (Baltimore). 2019 Nov;98(48):e18148. doi: 10.1097/MD.0000000000018148.

  PMID: 31770255 BACKGROUND

• Pekar-Zlotin M, Rabinovich I, Goldrat I, Vaknin Z, Gidoni Y, Zur-Naaman H, Maymon R, Smorgick N. Ovarian Dermoid Cysts Associated with Paraneoplastic Syndrome N-methyl-D-aspartic Acid Receptor Antibodies Encephalitis. J Minim Invasive Gynecol. 2021 Jun;28(6):1190-1193. doi: 10.1016/j.jmig.2020.09.018. Epub 2020 Sep 24.

  PMID: 32979534 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples with extraction of plasma

MeSH Terms

Conditions

Teratoma, Ovarian

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Noam Smorgick, M.D

  Assaf-Harofeh Medical Center

  STUDY DIRECTOR

Central Study Contacts

Hilli Zur Naaman, M.D

CONTACT

972508334458; hillizur@gmail.com

Noam Smorgick, M.D

CONTACT

972505191516; noam_yossi@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Noam Smorgick MD, Director of Minimally Invasive Gynecology

Study Record Dates

• First Submitted: September 12, 2021
• First Posted: February 4, 2022
• Study Start: January 1, 2020
• Primary Completion: October 30, 2022
• Study Completion: October 30, 2022
• Last Updated: February 4, 2022

Record last verified: 2022-01

Locations

IL (1)