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Clinical Validation of a Molecular Signature to Detect Cancer in Thyroid Nodules With Indeterminate Cytology (CITHY)

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ClinicalTrials.gov Identifier: NCT02225509
Recruitment Status : Unknown
Verified October 2014 by Diaxonhit.
Recruitment status was:  Recruiting
First Posted : August 26, 2014
Last Update Posted : October 24, 2014
Sponsor:
Information provided by (Responsible Party):
Diaxonhit

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 distincts cohorts of samples to determine the malignant or benign profile of a thyroid nodule with indeterminate cytological analysis. The target population includes categories III [Follicular lesion of undetermined significance or Atypia of undetermined significance (FLUS/AUS)] and IV [Follicular neoplasm / Suspicious for follicular neoplasm (FN/SFN)] of the Bethesda classification.

    The expected target performance of the Dx15 molecular test in this target population is 95% for specificity with a lower limit of the 95% confidence interval of 87%, and 75% for sensitivity.

  2. Secondary objectives:

    • 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.
  3. 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.

Condition or disease Intervention/treatment Phase
Thyroid Nodule Thyroid Cancer Procedure: FNA biopsy for thyroid nodule(s) Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Clinical Validation of the Diagnostic Performance of a Molecular Signature to Determine the Malignant or Benign Profile of a Thyroid Nodule With Indeterminate Cytological Analysis
Study Start Date : October 2014
Estimated Primary Completion Date : December 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Thyroid

Arm Intervention/treatment
Patients with thyroid nodules
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)

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.





Primary Outcome Measures :
  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. [ Time Frame: 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) ]
    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.


Secondary Outcome Measures :
  1. Performance of mutations analyses versus histological results or clinical follow up outcome [ Time Frame: 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) ]
    Comparison of the results of mutation tests conducted under blind conditions and the histological results after re-reading or in patients involved in the monitoring programme (eg, the correlation of the presence of mutations with the presence of thyroid cancer diagnosed by histological analysis)

  2. Performance of TIRADS scores versus histological results or clinical follow up outcome [ Time Frame: 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) ]
    Predictive performances of the TI-RADS score by comparing the scores obtained with the histological results after reading or in patients involved in the monitoring programme (eg, verify if higher scores are correlated with an increased prevalence of cancer)

  3. Combination of Dx15 test results with one or more other study parameters results versus histological results or clinical follow up outcome [ Time Frame: 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) ]
    Diagnostic performances of the combination of the signature with other study tests and by comparing the scores from the combination of tests (ie, algorithm approach) with the histological results or the clinical follow-up outcome.

  4. Any additional relevant descriptive analyses based on data or set of data recorded during the study [ Time Frame: 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 other relevant statistical analysis based on data collected during the study can be carried out and will be listed in the statistical analysis plan of the study.

    • descriptive performance (sensitivity, specificity) of the Dx15 signature in any study subpopulation defined by data collected during the study (eg, male vs female; vs age range, vs different types of histology, vs existing thyroid familial history, vs specified type of thyroid mutations, vs volume of the thyroid nodule)
    • descriptive data regarding time from FNA analysis to surgery with regards to the Bethesda cytology score
    • descriptive data regarding prevalence of cancer vs thyroid nodule volume, TIRADS score and Bethesda results
    • comparison of cytology inter-reader performance (center vs central reading) globally and for each Bethesda score



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  1. 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.
  2. 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.
  3. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02225509


Contacts
Contact: Olivier SOL, MD +33153947700 olivier.sol@diaxonhit.com

Locations
France
Recruiting
Angers, France
Sponsors and Collaborators
Diaxonhit

Responsible Party: Diaxonhit
ClinicalTrials.gov Identifier: NCT02225509     History of Changes
Other Study ID Numbers: 2014-A00971-46
First Posted: August 26, 2014    Key Record Dates
Last Update Posted: October 24, 2014
Last Verified: October 2014

Keywords provided by Diaxonhit:
Thyroid cancer
Thyroid cancer diagnostic
Thyroid nodule
Fine needle aspiration biopsy
Indeterminate cytological result
Molecular diagnostic
Transcriptomics
Molecular signature

Additional relevant MeSH terms:
Thyroid Diseases
Thyroid Neoplasms
Thyroid Nodule
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms