Status:
UNKNOWN
Clinical Validation of a Molecular Signature to Detect Cancer in Thyroid Nodules With Indeterminate Cytology
Lead Sponsor:
Diaxonhit
Conditions:
Thyroid Nodule
Thyroid Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
1. Principal objective: The primary objective of this study is to validate the diagnostic performance of a Dx15 molecular test based on molecular transcriptomic signatures previously identified in...
Detailed Description
The study is intended for patients for whom a fine-needle aspiration biopsy of thyroid nodule/nodules is medically indicated for the detection of thyroid cancer. Fine-needle aspiration biopsy should p...
Eligibility Criteria
Inclusion
- Patient selection criteria:
- Men or women aged 18 years or older,
- Patient presenting with at least one thyroid nodule for which a fine needle aspiration biopsy is indicated for the diagnosis of thyroid cancer,
- Patient covered by a social security program or benefiting from a comparable program,
- Patient having signed a written informed consent form to participate in the study. N.B.: the patient must also have signed a specific form for mutation analyses.
- Patient inclusion criteria:
- Selection criteria,
- Patient having undergone a fine-needle aspiration biopsy of a thyroid nodule, the cytological results of which should be classified according to the Bethesda criteria,
- Patient whose surgical specimen is likely to have undergone histological analysis (benign/malignant) or at least a follow-up and monitoring program allowing diagnosis.
- Non-inclusion criteria:
- Adults over 18 years of age who are under legal protection or are unable to give their consent,
- Patient taking part in another clinical trial likely to affect thyroid function, in the previous month or during the screening process,
- Patients currently receiving treatment for cancer or in remission for less than two years (except basal or squamous cell skin cancers),
- Patient presenting with multinodular goitre with no dominant module, i.e. a nodule easily identifiable on imaging and which can monitored throughout the study,
- Patient not likely to comply with the protocol and, in particular, not to be followed up by the investigating centre throughout the study,
- Clinically significant, acute and/or unstable disease, which, in the investigator's opinion, is likely to interfere significantly with patient evaluations and follow-up during the study.
Exclusion
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT02225509
Start Date
October 1 2014
Last Update
October 24 2014
Active Locations (1)
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1
Angers, France