Clinical trial NCT04053114: MOLecular Characterization and Treatment of THYroid Carcinoma on Struma Ovarii
Official title: MOLecular Characterization and Treatment of THYroid Carcinoma on Struma Ovarii
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ovarian Cancer
Keywords: Ovarian teratoma
struma ovarii
thyroid carcinoma
next generation sequencing
Lead sponsor: Institut Bergonié
Sponsor class: OTHER
First posted: 2019-08-12
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
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.

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Treatment description
timeFrame: Between first treatment and last follow up, assessed up to 100 months
Secondary outcomes:
measure: Age of diagnostic (years)
timeFrame: At baseline (first treatment)
measure: Comorbidities
timeFrame: At baseline (first treatment)
measure: FIGO stage
timeFrame: At baseline (first treatment)
measure: Histologic type
timeFrame: At baseline (first treatment)
measure: Survival
timeFrame: Between first treatment and last follow up, assessed up to 100 months
measure: Prognostic factors
timeFrame: At baseline (first treatment)
measure: Focus on genes of interest in thyroid carcinomas
timeFrame: At baseline (first treatment)
measure: Focus on ALK translocation
timeFrame: At baseline (first treatment)
measure: Focus on TERT mutation
timeFrame: At baseline (first treatment)
measure: Comparison of the tissue samples genomic profile with the Thyroid carcinoma TCGA genomic profile
timeFrame: At baseline (first treatment)
measure: Comparison between TCSO tissue samples genomic profile and benign SO tissue samples genomic profile
timeFrame: At baseline (first treatment)
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Institut Bergonié
state: Aquitaine
Study officials:
References: