MOLecular Characterization and Treatment of THYroid Carcinoma on Struma Ovarii (MOLTHYSO)

Thyroid carcinoma on struma ovarii (TCSO) is a rare ovarian tumor, derivate from monodermic teratomas. It represents about 0.01% of overall ovarian tumours, and 5 to 10% of struma ovarii. The diagnosis is histologic and retrospective after pelvic surgery. Because of its rarity, the treatment of TCSO is not consensual and should be validated in multidisciplinary team involved in rare ovarian carcinoma. TCSO should be taken care of as a thyroid carcinoma, in case of relapse, with systemic treatment, as tyrosine kinase inhibitor (TKI), without any clinical trial proving this benefit. Indeed, molecular profiles and genomic expression is unknown, because of studies with few patients (less than 10) contrary to thyroid carcinomas with the TCGA genomic classification. The study purposes are the outcome of the patients after the first treatment and the comparison of the genomic profil in next generation sequencing (NGS) with TCGA thyroid carcinoma profile. Thus, the treatment could be tailored, confirming the same therapy as in thyroid carcinoma.

Study Overview

• Status: Withdrawn
• Conditions: Ovarian Cancer
• Intervention / Treatment: Other: DNA and RNA extraction from FFPE or frozen tissue sample

Detailed Description

This is a retrospective cohort with collection of tissues samples (FFPE or frozen), including female patients >18-year-old treated in French between 2009 and 2016 for a thyroid carcinoma on struma ovarii. Clinical data and tissues will be centralized for assessment. One of the endpoint is the description of the population (such as baseline clinical and pathologist characteristics, first treatment, survival, treatment relapse) ; the other endpoint is the comparison between the genomic profile of the tumor tissues obtained in NGS and those of the thyroid carcinomas obtained from the TCGA.

• Study Type: Observational

Contacts and Locations

Study Locations

• France
  • Aquitaine
    • Bordeaux, Aquitaine, France, 33076
      • Institut Bergonie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

French women older than 18 years old with a TCSO registered in the French " Rare malignant gynecologic tumors " network from 2007 to 2017.

Description

Inclusion Criteria:

• Alive patients,
• Age > 18 years,
• Treatment in France for a TCSO, proven by an histologic diagnosis and registered in the " rare malignant gynecologic tumors " network.

Exclusion Criteria:

- Patient lost to follow up.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Retrospective cohort; Tissue samples	Other: DNA and RNA extraction from FFPE or frozen tissue sample; Next generation sequencing (NGS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment description	Description of the previous treatment for the TCSO (first treatment and relapse) in the retrospective cohort	Between first treatment and last follow up, assessed up to 100 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age of diagnostic (years)		At baseline (first treatment)
Comorbidities		At baseline (first treatment)
FIGO stage		At baseline (first treatment)
Histologic type		At baseline (first treatment)
Survival	Evaluation of the time to relapse, the progression free survival (if relapse) and the overall survivall	Between first treatment and last follow up, assessed up to 100 months
Prognostic factors	Find prognostic factors	At baseline (first treatment)
Focus on genes of interest in thyroid carcinomas	Research of expression of AKT1, BRAF, CTNNB1, FGFR3, HRAS, KRAS, NRAS, KIT or RET in the TCSO tissu samples	At baseline (first treatment)
Focus on ALK translocation	Assessed by FISH in the TCSO tissue samples	At baseline (first treatment)
Focus on TERT mutation	Assessed by Sanger sequencing in the TCSO tissue samples	At baseline (first treatment)
Comparison of the tissue samples genomic profile with the Thyroid carcinoma TCGA genomic profile		At baseline (first treatment)
Comparison between TCSO tissue samples genomic profile and benign SO tissue samples genomic profile		At baseline (first treatment)

Collaborators and Investigators

• Sponsor: Institut Bergonié
• Investigators: Principal Investigator: Anne FLOQUET, MD, Institut Bergonie

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2019
• Primary Completion (Estimated): December 1, 2020
• Study Completion (Estimated): December 1, 2020

Study Registration Dates

• First Submitted: July 4, 2019
• First Submitted That Met QC Criteria: August 9, 2019
• First Posted (Actual): August 12, 2019

Study Record Updates

• Last Update Posted (Estimated): August 29, 2025
• Last Update Submitted That Met QC Criteria: August 22, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: next generation sequencing; thyroid carcinoma; Ovarian teratoma; struma ovarii
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms by Histologic Type; Genital Diseases, Female; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Neoplasms, Female; Gonadal Disorders; Neoplasms, Germ Cell and Embryonal; Thyroid Diseases; Teratoma; Ovarian Neoplasms; Thyroid Neoplasms; Teratoma, Ovarian; Struma Ovarii; Nucleic Acids; Nucleic Acids, Nucleotides, and Nucleosides; DNA
• Other Study ID Numbers: IB2018-MOLTHYSO; MR 0016040319 (Other Identifier: Institut National des Données de Santé (INDS))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No