NCT02225509

Brief Summary

  • To assess the performance of the Dx15 test in samples collected during the study by fine-needle aspiration (FNA) in each and in all of the indeterminate Bethesda classification categories (categories III, IV and V: suspected malignancy)
  • To assess the performance of the TI-RADS ultrasonography score for diagnosing thyroid cancer in patients presenting with a thyroid nodule and having available cytological analysis results.
  • To check the potential of performance of the molecular signature as well as of its combination with other tests by applying it in a blind manner to samples collected from patients presenting with thyroid nodules and whose aspiration biopsy result is benign (Bethesda category II), malignant (Bethesda category VI) or non-diagnostic (Bethesda category I)
  • To assess the performance of mutation tests (isolated mutations, chromosomal rearrangements) for diagnosing thyroid cancer in patients presenting with a thyroid nodule and with available cytological results.
  • To estimate the performance of the combination of the Dx15 test result and other diagnostic tools such as mutation tests and/or the TI-RADS score to diagnose thyroid cancer in patients presenting with a thyroid nodule and having an indeterminate cytology result (especially AUS/FLUS and FN/SFN). The combination of Dx15 diagnostic test results with other study parameters will also be considered in order to establish the option of an algorithmic approach for the diagnosis of thyroid cancer.
  • To compare the results of cytological and histological analyses obtained in the centres and by centralised reading and assessment of the impact of its results on the other study analyses and parameters.
  • Additional analyses deemed relevant on the basis of various parameters and data collected during the study.
  • Objective of exploratory research:
  • The use of all or part of the FNA samples for the purpose of research as part of thyroid cancers, especially with the objective of optimising or identifying additional molecular signatures.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 26, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Last Updated

October 24, 2014

Status Verified

October 1, 2014

Enrollment Period

2.2 years

First QC Date

August 19, 2014

Last Update Submit

October 23, 2014

Conditions

Thyroid NoduleThyroid Cancer

Keywords

Thyroid cancerThyroid cancer diagnosticThyroid noduleFine needle aspiration biopsyIndeterminate cytological resultMolecular diagnosticTranscriptomicsMolecular signature

Outcome Measures

Primary Outcomes (1)

  • Proportion of correct classifications for defining the malignant or benign nature of a FNA biopsy in patients with thyroid nodules and an indeterminate cytology for Bethesda categories III and IV.

    The primary endpoint criterion will be the proportion of correct classifications for defining the malignant or benign nature of a fine-needle aspiration biopsy carried out in patients presenting with thyroid nodules and an indeterminate cytology for Bethesda categories III and IV. The results obtained with the signature will be compared to the histology results of the surgical specimen or, failing that, to the results of the monitoring program implemented by the clinician.

    Time to thyroid surgery specimen analysis or clinical follow-up of the patient (min. 12 months or up to the last patient last visit of the study)

Secondary Outcomes (4)

  • Performance of mutations analyses versus histological results or clinical follow up outcome

    Time to thyroid surgery specimen analysis or clinical follow-up of the patient (min. 12 months or up to the last patient last visit of the study)

  • Performance of TIRADS scores versus histological results or clinical follow up outcome

    Time to thyroid surgery specimen analysis or clinical follow-up of the patient (min. 12 months or up to the last patient last visit of the study)

  • Combination of Dx15 test results with one or more other study parameters results versus histological results or clinical follow up outcome

    Time to thyroid surgery specimen analysis or clinical follow-up of the patient (min. 12 months or up to the last patient last visit of the study)

  • Any additional relevant descriptive analyses based on data or set of data recorded during the study

    Time to thyroid surgery specimen analysis or clinical follow-up of the patient (min. 12 months or up to the last patient last visit of the study)

Study Arms (1)

Patients with thyroid nodules

OTHER

Patients with thyroid nodules with an indication for FNA biopsy to detect thyroid cancer. These patients will undergo FNA at the time of first visit and also when considered necessary by the clinician during the course of the study.

Procedure: FNA biopsy for thyroid nodule(s)

Interventions

FNA biopsy for thyroid nodule(s)PROCEDURE

The study is intended for patients for whom a FNA biopsy of thyroid nodule/nodules is medically indicated for the detection of thyroid cancer. FNA biopsy should preferably be carried out under ultrasound guidance. The FNA samples will be collected either from the remaining material of FNA or there will be dedicated FNA sample in order to ensure an adequate quantity of material for molecular analysis. The patients will also be invited to take part in the mutation study in a separate consent form. The samples of enrolled patients will be sent to the Diaxonhit Genomics Laboratory and analysed using Diaxonhit technology after checking the quantity and quality of the samples. Enrolled patients whose samples are inadequate in terms of quantity or quality for the various molecular tests will not be considered for the study. If necessary, mutation analyses can be carried out anonymously by an independent French laboratory and under the supervision of Diaxonhit.

Patients with thyroid nodules

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Angers, France

RECRUITING

MeSH Terms

Conditions

Thyroid NoduleThyroid Neoplasms

Interventions

Biopsy, Fine-Needle

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Intervention Hierarchy (Ancestors)

Biopsy, NeedleBiopsyCytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativePuncturesInvestigative Techniques

Central Study Contacts

Olivier SOL, MD

CONTACT

+33153947700olivier.sol@diaxonhit.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2014

First Posted

August 26, 2014

Study Start

October 1, 2014

Primary Completion

December 1, 2016

Last Updated

October 24, 2014

Record last verified: 2014-10

Locations

FR(1)