MOLecular Characterization and Treatment of THYroid Carcinoma on Struma Ovarii

Study Overview
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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.

Official Title
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MOLecular Characterization and Treatment of THYroid Carcinoma on Struma Ovarii

Conditions
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Ovarian Cancer

Intervention / Treatment
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* Other: DNA and RNA extraction from FFPE or frozen tissue sample


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Retrospective cohort<br>Tissue samples | Other: DNA and RNA extraction from FFPE or frozen tissue sample<br>* Next generation sequencing (NGS)<br>|

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ovarian teratoma, struma ovarii, thyroid carcinoma, next generation sequencing