MOLecular Characterization and Treatment of THYroid Carcinoma on Struma Ovarii

NCT04053114 | Withdrawn

• 2 other identifiers: IB2018-MOLTHYSOMR 0016040319
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ovarian Cancer

Keywords

Ovarian teratoma; struma ovarii; thyroid carcinoma; next generation sequencing

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Retrospective cohort

Tissue samples

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

Interventions

DNA and RNA extraction from FFPE or frozen tissue sample OTHER

Next generation sequencing (NGS)

Retrospective cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

French women older than 18 years old with a TCSO registered in the French " Rare malignant gynecologic tumors " network from 2007 to 2017.

You may qualify if:

• 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.

You may not qualify if:

• \- Patient lost to follow up.

Sponsors & Collaborators

• Institut Bergonié: lead

Study Sites (1)

Institut Bergonié

Bordeaux, Aquitaine, 33076, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Frozen or FFPE tumoral specimens suitable for DNA and RNA extraction.

MeSH Terms

Conditions

Ovarian Neoplasms; Teratoma, Ovarian; Struma Ovarii; Thyroid Neoplasms

Interventions

DNA

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Teratoma; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Head and Neck Neoplasms; Thyroid Diseases

Intervention Hierarchy (Ancestors)

Nucleic Acids; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Anne FLOQUET, MD

  Institut Bergonié

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2019
• First Posted: August 12, 2019
• Study Start: January 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)