Trials / Withdrawn
WithdrawnNCT04053114
MOLecular Characterization and Treatment of THYroid Carcinoma on Struma Ovarii
- Status
- Withdrawn
- Phase
- —
- Study type
- Observational
- Enrollment
- 0 (actual)
- Sponsor
- Institut Bergonié · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | DNA and RNA extraction from FFPE or frozen tissue sample | Next generation sequencing (NGS) |
Timeline
- Start date
- 2019-01-01
- Primary completion
- 2020-12-01
- Completion
- 2020-12-01
- First posted
- 2019-08-12
- Last updated
- 2025-08-29
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT04053114. Inclusion in this directory is not an endorsement.