MOLecular Characterization and Treatment of THYroid Carcinoma on Struma Ovarii

Ovarian Cancer Clinical Trial

— MOLTHYSO  

Official title:

MOLecular Characterization and Treatment of THYroid Carcinoma on Struma Ovarii

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04053114
• Other study ID #: IB2018-MOLTHYSO
• Secondary ID: MR 0016040319
• Status: Not yet recruiting
• Start date: September 2019
• Est. completion date: May 2020

Study information

• Verified date: July 2019
• Source: Institut Bergonié
• Contact: Anne FLOQUET, MD
• Phone: +33 5.56.33.33.33
• Email: a.floquet[@]bordeaux.unicancer.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: May 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Ovarian Cancer
• Thyroid Neoplasms

Intervention

Other:
• DNA and RNA extraction from FFPE or frozen tissue sample
Next generation sequencing (NGS)

Locations

Country	Name	City	State
France	Institut Bergonié	Bordeaux	Aquitaine

Sponsors (1)

Lead Sponsor	Collaborator
Institut Bergonié

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Age of diagnostic (years)		At baseline (first treatment)
Secondary	Comorbidities		At baseline (first treatment)
Secondary	FIGO stage		At baseline (first treatment)
Secondary	Histologic type		At baseline (first treatment)
Secondary	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
Secondary	Prognostic factors	Find prognostic factors	At baseline (first treatment)
Secondary	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)
Secondary	Focus on ALK translocation	Assessed by FISH in the TCSO tissue samples	At baseline (first treatment)
Secondary	Focus on TERT mutation	Assessed by Sanger sequencing in the TCSO tissue samples	At baseline (first treatment)
Secondary	Comparison of the tissue samples genomic profile with the Thyroid carcinoma TCGA genomic profile		At baseline (first treatment)
Secondary	Comparison between TCSO tissue samples genomic profile and benign SO tissue samples genomic profile		At baseline (first treatment)