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

August 22, 2025 updated by: Institut Bergonié
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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Treatment description
Time Frame: Between first treatment and last follow up, assessed up to 100 months
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Age of diagnostic (years)
Time Frame: At baseline (first treatment)
At baseline (first treatment)
Comorbidities
Time Frame: At baseline (first treatment)
At baseline (first treatment)
FIGO stage
Time Frame: At baseline (first treatment)
At baseline (first treatment)
Histologic type
Time Frame: At baseline (first treatment)
At baseline (first treatment)
Survival
Time Frame: Between first treatment and last follow up, assessed up to 100 months
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
Time Frame: At baseline (first treatment)
Find prognostic factors
At baseline (first treatment)
Focus on genes of interest in thyroid carcinomas
Time Frame: At baseline (first treatment)
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
Time Frame: At baseline (first treatment)
Assessed by FISH in the TCSO tissue samples
At baseline (first treatment)
Focus on TERT mutation
Time Frame: At baseline (first treatment)
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
Time Frame: At baseline (first treatment)
At baseline (first treatment)
Comparison between TCSO tissue samples genomic profile and benign SO tissue samples genomic profile
Time Frame: At baseline (first treatment)
At baseline (first treatment)

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institut Bergonié

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Anne FLOQUET, MD, Institut Bergonie

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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2019

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2020

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 4, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 9, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 12, 2019

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 29, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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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