MOLecular Characterization and Treatment of THYroid Carcinoma on Struma Ovarii

NCT04053114 — Withdrawn, Institut Bergonié

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RegistryNCT04053114, acronym MOLTHYSO
StatusWithdrawn - Principal investigator left the investigational center and nobody took over.
Study typeObservational
SponsorInstitut Bergonié (Other)
ConditionsOvarian Cancer
InterventionsDNA and RNA extraction from FFPE or frozen tissue sample (Other)
Datesstart 2019-01-01 (estimated), primary completion 2020-12-01 (estimated), completion 2020-12-01 (estimated), first posted 2019-08-12, last updated 2025-08-29
Locations1 site in France

Related Papers Related Patents Related Grants Related Experts
All trials for Ovarian Cancer All trials of DNA and RNA extraction from FFPE or frozen tissue sample

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Retrospective cohortOther: DNA and RNA extraction from FFPE or frozen tissue sampleTissue samples
  • DNA and RNA extraction from FFPE or frozen tissue sample (Other): Next generation sequencing (NGS)

+Outcome measures

Primary outcomes

  • 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

+Eligibility

Sex: Female, ages: 18 Years to any

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.

+Locations (1)

FacilityCityCountryStatus
Institut BergoniéBordeaux, AquitaineFrance

+Investigators

  • Anne FLOQUET, MD, Principal investigator, Institut Bergonié