The main objective of the research is to differentiate between benign and malignant thyroid nodules using the GC-IMS for the analysis of breath, urine and blood in a (multicenter) study and reduce the amount of unnecessary surgery.
ID
Source
Brief title
Condition
- Thyroid gland disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary parameters of diagnostic accuracy will be sensitivity, positivity,
and ROC-AUC (Area Under the Curve of the Receiver Operating Characteristics
curve) of the GC-IMS model for detecting thyroid malignancy.
Secondary outcome
Secondary outcomes: A database will be maintained with patient characteristics,
quality of life and emotional burden questionnaires, and surgical complications
(hypoparathyroidism, bleeding, wound infection, damage to the vocal cord nerve,
duration of the hospital stay) with accompanying clavien-dindo classification.
The number of unnecessary surgeries will be evaluated.
Refusing to participate in the study will be tracked to evaluate patient
acceptance of the Aeonose in clinical practice. Participating patients will
assess the convenience of using the Aeonose by means of a VAS scale.
Sensitivity and specificity of molecular diagnostics (BRAF mutation) on the
cytology of thyroid punctures, urine and blood after regular blood sampling
will be evaluated. Tissue obtained from the patients will be examined.
Background summary
Patients with a suspected thyroid nodule face an invasive and patient
unfriendly diagnostic work-up to obtain better insight in the chances of
malignancy of their nodule. Therefore, patients undergo ultrasound of the
thyroid gland followed by fine-needle aspiration for cytology (FNAC). The
latter, resulting in the Bethesda classification, is considered as the golden
standard procedure for diagnosis. In case of Bethesda III cytology, 82-94% of
the surgeries are superfluous because the thyroid nodules appear to be benign
after resection. This happens in Bethesda IV in 60-90% and Bethesda V in 40-55%
of all thyroid surgeries. Unnecessary surgery exposes patients to unnecessary
risks related to surgery. Most common thyroid surgery complications are damage
to the recurrent laryngeal nerve and/or parathyroid gland. This study is of
relevance because it aims at reducing unnecessary diagnostic procedures, such
as a diagnostic hemithyroidectomy, and thereby reducing the risk of unnecessary
harm to patients with a suspected thyroid nodule.
Study objective
The main objective of the research is to differentiate between benign and
malignant thyroid nodules using the GC-IMS for the analysis of breath, urine
and blood in a (multicenter) study and reduce the amount of unnecessary
surgery.
Study design
Prospective (multicenter) observational study.
Study burden and risks
This study has no specific benefits for the participating patients. Possible
side effects during measurements,with the sampling bags, are dizziness and
nausea, usually due to hyperventilation. Other side effects are hypo- or hyper
salivation during measurements. Blood will be collected during regular
pre-operative blood collection, resulting in no extra skin puncture.
Furthermore two quick to answer questionnaires as well as a short case report
form (CRF) will be filled in by the participating patients. Using the Aeonose
as a non-invasive, rapid and inexpensive diagnostic tool could be a major
benefit for patients with thyroid nodules due to the faster and less invasive
diagnostic process. Benefits for patients with benign thyroid diseases include
the possibility to resign from unnecessary invasive treatments such as
(diagnostic) surgery.
P. Debyelaan 25
Maastricht 6229 HX
NL
P. Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
- Thyroid nodule requiring additional diagnostic follow-up (TI-RADS/Bethesda)
- Patients with thyroid problems requiring surgery (e.g. goiter)
- Breath collection before undergoing cytological puncture or at least 3 days
after cytological puncture pre-operatively.
- > 18 year.
- Signed informed consent,
Exclusion criteria
- Other underlying malignancy, (less than 5 years ago), basal cell carcinoma
not included
- Unable to participate due to comorbidities (e.g. COPD)
- Not understanding the information
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | https://www.kanker.nl/trials/1085 |
| CCMO | NL76036.068.21 |