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MOLecular Characterization and Treatment of THYroid Carcinoma on Struma Ovarii

Straipsnius versti gali tik registruoti vartotojai
Prisijungti Registracija
Nuoroda įrašoma į mainų sritį
StatusasKol kas neužverbuoja
Rėmėjai
Institut Bergonié

Raktažodžiai

Santrauka

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.

apibūdinimas

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.

Datos

Paskutinį kartą patikrinta: 06/30/2019
Pirmasis pateikimas: 07/03/2019
Numatytas registravimas pateiktas: 08/08/2019
Pirmas paskelbtas: 08/11/2019
Paskutinis atnaujinimas pateiktas: 08/08/2019
Paskutinis atnaujinimas paskelbtas: 08/11/2019
Faktinė studijų pradžios data: 08/31/2019
Numatoma pirminio užbaigimo data: 11/30/2019
Numatoma studijų užbaigimo data: 04/30/2020

Būklė ar liga

Ovarian Cancer

Intervencija / gydymas

Other: Retrospective cohort

Fazė

-

Rankų grupės

RankaIntervencija / gydymas
Retrospective cohort
Tissue samples
Other: Retrospective cohort
Next generation sequencing (NGS)

Tinkamumo kriterijai

Amžius, tinkami studijuoti 18 Years Į 18 Years
Tinkamos studijoms lytysFemale
Mėginių ėmimo metodasNon-Probability Sample
Priima sveikus savanoriusTaip
Kriterijai

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.

Rezultatas

Pirminės rezultatų priemonės

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

Antrinės rezultatų priemonės

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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