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MOLecular Characterization and Treatment of THYroid Carcinoma on Struma Ovarii

Samo registrirani uporabniki lahko prevajajo članke
Prijava / prijava
Povezava se shrani v odložišče
StanjeŠe ne zaposluje
Sponzorji
Institut Bergonié

Ključne besede

Povzetek

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.

Opis

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.

Datumi

Nazadnje preverjeno: 06/30/2019
Prvič predloženo: 07/03/2019
Predviden vpis oddan: 08/08/2019
Prvič objavljeno: 08/11/2019
Zadnja posodobitev oddana: 08/08/2019
Zadnja posodobitev objavljena: 08/11/2019
Dejanski datum začetka študija: 08/31/2019
Predvideni datum primarnega zaključka: 11/30/2019
Predvideni datum zaključka študije: 04/30/2020

Stanje ali bolezen

Ovarian Cancer

Intervencija / zdravljenje

Other: Retrospective cohort

Faza

-

Skupine rok

RokaIntervencija / zdravljenje
Retrospective cohort
Tissue samples
Other: Retrospective cohort
Next generation sequencing (NGS)

Merila upravičenosti

Starost, primerna za študij 18 Years Za 18 Years
Spol, upravičen do študijaFemale
Metoda vzorčenjaNon-Probability Sample
Sprejema zdrave prostovoljceDa
Merila

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.

Izid

Primarni izidni ukrepi

1. 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

Ukrepi sekundarnega rezultata

1. Age of diagnostic (years) [At baseline (first treatment)]

2. Comorbidities [At baseline (first treatment)]

3. FIGO stage [At baseline (first treatment)]

4. Histologic type [At baseline (first treatment)]

5. 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

6. Prognostic factors [At baseline (first treatment)]

Find prognostic factors

7. 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

8. Focus on ALK translocation [At baseline (first treatment)]

Assessed by FISH in the TCSO tissue samples

9. Focus on TERT mutation [At baseline (first treatment)]

Assessed by Sanger sequencing in the TCSO tissue samples

10. Comparison of the tissue samples genomic profile with the Thyroid carcinoma TCGA genomic profile [At baseline (first treatment)]

11. Comparison between TCSO tissue samples genomic profile and benign SO tissue samples genomic profile [At baseline (first treatment)]

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