The Butterfly-study: The Detection of Thyroid Cancer via VOCs using GC-IMS

Recruiting

Conditions: Thyroid Cancer
10043739

Registration Number: NL-OMON51970

Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 1500

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

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary parameters of diagnostic accuracy will be sensitivity, positivity,<br /><br>and ROC-AUC (Area Under the Curve of the Receiver Operating Characteristics<br /><br>curve) of the GC-IMS model for detecting thyroid malignancy. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes: A database will be maintained with patient characteristics,<br /><br>quality of life and emotional burden questionnaires, and surgical complications<br /><br>(hypoparathyroidism, bleeding, wound infection, damage to the vocal cord nerve,<br /><br>duration of the hospital stay) with accompanying clavien-dindo classification.<br /><br>The number of unnecessary surgeries will be evaluated.<br /><br>Refusing to participate in the study will be tracked to evaluate patient<br /><br>acceptance of the Aeonose in clinical practice. Participating patients will<br /><br>assess the convenience of using the Aeonose by means of a VAS scale.<br /><br>Sensitivity and specificity of molecular diagnostics (BRAF mutation) on the<br /><br>cytology of thyroid punctures, urine and blood after regular blood sampling<br /><br>will be evaluated. Tissue obtained from the patients will be examined. </p><br>