MOLecular Characterization and Treatment of THYroid Carcinoma on Struma Ovarii

NCT ID: NCT04053114

Last Updated: 2025-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2020-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Ovarian Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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Retrospective cohort

Tissue samples

DNA and RNA extraction from FFPE or frozen tissue sample

Intervention Type OTHER

Next generation sequencing (NGS)

Interventions

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DNA and RNA extraction from FFPE or frozen tissue sample

Next generation sequencing (NGS)

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Institut BergoniƩ

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anne FLOQUET, MD

Role: PRINCIPAL_INVESTIGATOR

Institut BergoniƩ

Locations

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Institut BergoniƩ

Bordeaux, Aquitaine, France

Site Status

Countries

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France

Other Identifiers

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MR 0016040319

Identifier Type: OTHER

Identifier Source: secondary_id

IB2018-MOLTHYSO

Identifier Type: -

Identifier Source: org_study_id

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