Objective: The purpose of this study is to compare the diagnostic surgical rate of a matched control group, derived from a retrospective review of patients without GEC testing, with a prospective GEC tested group.
ID
Source
Brief title
Condition
- Thyroid gland disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters/endpoints: The primary study endpoint is the comparison
of diagnostic surgical rates between the historical control group (the
retrospective review of patients without GEC testing) and a prospective group
in which the GEC test is added to the regular clinical management of patients
with cytologically indeterminate nodules enrolled in this study.
Secondary outcome
Clinical data will be collected.
Background summary
Rationale: Approximately 15 to 30% of thyroid nodules evaluated by means of
fine-needle aspirate biopsy (FNAB) are not clearly benign or malignant.
Patients with cytological indeterminate nodules (Bethesda III/IV) are often
referred for diagnostic surgery, though most of these nodules prove to be
benign. A novel diagnostic test that measures the expression of 167 genes (the
Afirma gene expression classifier (GEC)) has shown to identify many benign
thyroid nodules accurately when FNA results were cytological indeterminate.
Study objective
Objective: The purpose of this study is to compare the diagnostic surgical rate
of a matched control group, derived from a retrospective review of patients
without GEC testing, with a prospective GEC tested group.
Study design
Study design: We will perform a retrospective study to describe the clinical
management of patients undergoing thyroid fine needle aspirate biopsy resulting
in an indeterminate cytopathology diagnoses (Bethesda III/IV) in the absence of
molecular diagnostic testing. The operative rate within the first year after
FNAB will be calculated for this retrospective cohort. Next, prospectively,
patients with indeterminate cytopathology will be offered GEC testing in the
absence of other reasons to operate. Clinician(s) will receive the test result
to incorporate into clinical decision making, and patients will then receive
care as decided locally. Primary outcome is the percentage of patients who
underwent diagnostic surgery. Prospective cases will be matched against
historical controls. Matching will be performed blinded to the management
outcome after FNA. The subjects will be matched according to the following
characteristics: Age, gender, FNA result and hospital. Factors influencing the
decision regarding surgery such as ultrasound characteristics, cytopathology
and clinical findings, will be evaluated.
Study burden and risks
There are no extra risks associated with the GEC test other than the risks of
FNA. Considering the major impact of surgery on quality of life, a significant
reduction in the number of diagnostic surgeries will benefit a lot of patients.
It will also prevent life-long replacement with levothyroxine which is often
required after diagnostic surgery. The GEC test result is added to the regular
clinical management as one of several factors for clinical decision making. A
benign GEC result reduces the risk of malignancy to less than 6% justifying a
wait and see policy in the majority of patients. This is currently the standard
of care for patients with a Bethesda II FNA result, with have the same
malignancy risk. All patients with a GEC benign result will be closely
monitored with repeat ultrasound after 6 months and then annually for at least
5 years.
's-Gravendijkwal 230
Rotterdam 3015CE
NL
's-Gravendijkwal 230
Rotterdam 3015CE
NL
Listed location countries
Age
Inclusion criteria
Patients will be eligible for inclusion in the study if the following criteria are met:
1. Patient with FNAB of a thyroid nodule with a Bethesda III or IV cytopathology diagnosis
2. Patient age at the time of FNAB was 18 or older
3. No adjunctive molecular testing has been performed on the thyroid nodule
4. There are no other reasons for which surgery is planned regardless of the cytopathologial results.
Exclusion criteria
1. Patient has other nodule(s) in thyroid known to have diagnosis of Bethesda V or VI cytopathology, or pathological lymphnodes indicative of thyroid malignancy.
2. Surgery is already likely or planned regardless of the FNAB result due to cosmesis, rapid nodule growth, symptoms, patient request or physician recommendation
3. There are reasons for which surgery not applicable regardless of the cytopathologial results.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL54010.078.15 |
| OMON | NL-OMON27479 |