Date: 2014-11-18
Type of information: Initiation of the trial
phase:
Announcement: initiation of the trial
Company: Diaxonhit (France)
Product: Dx15
Action
mechanism: DX15 is a molecular test based on transcriptomic signatures. In 2012, the Caisse Nationale d\'Assurance Maladie (French CMS) found that 7,270 thyroid ablations were performed in France, while identified nodules that were analyzed post-surgery were benign. To avoid such unnecessary, costly and invasive surgeries, a sample from the suspicious nodule is collected by fine needle aspiration and analyzed by a cytopathologist. However, approximately 20% of such analyses remain inconclusive since the benign or malignant status cannot be determined. The objective of DX15 is to perform a more detailed molecular analysis of indeterminate samples in order to minimize unnecessary surgeries.
Disease: thyroid cancer
Therapeutic area: Cancer - Oncology - Diagnostic
Country: France
Trial
details: The CITHY clinical study (Cytologie Indéterminée de la THYroïde - indeterminate thyroid cytology) is a multicenter prospective diagnostic study. The main objective of this blind study is to validate the diagnostic performance of DX15 molecular test on transcriptomic signatures, previously identified on separate cohorts of samples,for the determination of the malignant or benign status of thyroid nodules which cytology proved indeterminate. The target population includes categories III (atypia of indeterminate significance or follicular lesion of indeterminate significance (AUS / FLUS)) and IV (follicular neoplasm or suspicion of follicular neoplasm (FN / SFN)) of the Bethesda classification. This study received a favorable opinion from the Ethics Committee on July 1, 2014 and authorization from
ANSM (French health authority) on August 6, 2014.
The study plans to include about 1000 patients in twenty European investigation centers, all experts in the diagnosis and monitoring of thyroid cancer. All patients will be followed until obtaining the malignancy or benignity status of nodules, that will be subject to cytology following a fine needle aspiration, by histological analysis of the surgical specimen or, in its absence, of clinical monitoring. The duration of the inclusion period is estimated at about 14 months. Monitoring of patients who underwent surgery will be performed until histological results are provided. For no-surgery patients, monitoring will last for a minimum of one year from inclusion. The clinical assessment of patients without surgery will continue for up to 12 months after the last patient enters the study in order to benefit from extended follow-up for patients entering early into the study. Given the length of monitoring, the total duration of the study should be approximately 26 months from the first recruitment.
Latest
news: * On November 18, 2014, Diaxonhit, a French leader in specialty in-vitro diagnostics for transplantation, infectious diseases and cancer, announced that the clinical study for the validation of Dx15, a molecular test for thyroid cancer, recently started. The goal of Dx15 is to enable surgeons to assess the benign or malignant status of a thyroid nodule when cytological analysis remains indeterminate. Diaxonhit is the sponsor of this study entitled CITHY (Cytologie Indéterminée de la THYroïde - Indeterminate Thyroid Cytology), which received a favorable opinion from regulatory authorities. As of October 31, 2014, the first patients were already included in France.
The company successfully completed the first two phases of development of DX15. During an initial feasibility study, more than 200 biomarkers that showed a statistically significant difference between benign and malignant nodules, were first identified. It was followed by an identification phase in which several very promising transcriptomic signatures were selected, with different molecular profiles than those of US competitors. With the CITHY clinical study, the final stage of development aims at determining DX15 clinical
performance on a statistically significant basis. In this context, the CITHY study will recruit approximately 1,000 patients in twenty European clinical centers, all experts in the diagnosis and monitoring of thyroid cancer.
