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MOLecular Characterization and Treatment of THYroid Carcinoma on Struma Ovarii (MOLTHYSO)

I

Institut Bergonié

Status

Unknown

Conditions

Ovarian Cancer

Treatments

Other: DNA and RNA extraction from FFPE or frozen tissue sample

Study type

Observational

Funder types

Other

Identifiers

NCT04053114
MR 0016040319 (Other Identifier)
IB2018-MOLTHYSO

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

20 participants in 1 patient group

Retrospective cohort
Description:
Tissue samples
Treatment:
Other: DNA and RNA extraction from FFPE or frozen tissue sample

Trial contacts and locations

1

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Central trial contact

Simone MATHOULIN-PELISSIER, MD, PhD; Anne FLOQUET, MD

Data sourced from clinicaltrials.gov

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