MOLecular Characterization and Treatment of THYroid Carcinoma on Struma Ovarii
- Conditions
- Ovarian Cancer
- Interventions
- Other: DNA and RNA extraction from FFPE or frozen tissue sample
- Registration Number
- NCT04053114
- Lead Sponsor
- Institut Bergonié
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 20
- 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.
- Patient lost to follow up.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Retrospective cohort DNA and RNA extraction from FFPE or frozen tissue sample Tissue samples
- Primary Outcome Measures
Name Time Method Treatment description 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
- Secondary Outcome Measures
Name Time Method Focus on TERT mutation At baseline (first treatment) Assessed by Sanger sequencing in the TCSO tissue samples
Comparison of the tissue samples genomic profile with the Thyroid carcinoma TCGA genomic profile At baseline (first treatment) Prognostic factors At baseline (first treatment) Find prognostic factors
Age of diagnostic (years) At baseline (first treatment) Comorbidities At baseline (first treatment) Histologic type At baseline (first treatment) Survival 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
FIGO stage At baseline (first treatment) Focus on ALK translocation At baseline (first treatment) Assessed by FISH in the TCSO tissue samples
Comparison between TCSO tissue samples genomic profile and benign SO tissue samples genomic profile At baseline (first treatment) Focus on genes of interest in thyroid carcinomas At baseline (first treatment) Research of expression of AKT1, BRAF, CTNNB1, FGFR3, HRAS, KRAS, NRAS, KIT or RET in the TCSO tissu samples
Trial Locations
- Locations (1)
Institut Bergonié
🇫🇷Bordeaux, Aquitaine, France