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Minimally Invasive Treatments of the Thyroid

ConditionPapillary Thyroid Microcarcinoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorEuropean Institute of Oncology

About this trial

This is a prospective cohort study to test Minimally Invasive Treatments of the Thyroid (MITT) as potential alternative to surgery in patients with Papillary Thyroid MicroCarcinoma (PTMC)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients > 18years

Patients with diagnosis of papillary thyroid microcarcinoma, citologically proven, suitable for MITT.

Written informed consent must be signed and dated by the patient and the investigator prior to inclusion.

Patients must be accessible for follow-up

Disqualifiers

Tumors > 1 cm, other citological type, refusal of MITT, unsuitable for MITT, unmanageable coagulative disorders

Patients with psychiatric, addictive, or any disorder, which compromises ability to give informed consent for participation in this study

Trial population

Patients with thyroid diseases suitable for "Minimally Invasive Treatments of the Thyroid (MITT)" as potential alternative to surgery

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • image-guided thermal ablation

    Procedure/Surgery

    image-guided thermal ablation in patients with diagnosis of micropapillary thyroid carcinoma

Treatment groups

270 Participants
are divided into 1 treatment group
Group A: image-guided thermal ablation1 intervention

Trial outcomes

Primary outcomes

1

The proportion of patients with major complications occurring within one month after the date of intervention

Complications will be reported according to modified Society of Interventional Radiology (SIR) classification

Time frame
1 month

Secondary outcomes

1

Percentage of patients with local recurrence at 10 years

Evaluation of disease free survival (DFS): percentage of patient whith a local recurrence at 10 years of follow up

Time frame
10 years
2

Percentage of patients with distant metastasis at 10 years

Evaluation of disease free survival (DFS): percentage of patient whith distant metastasis at 10 years of follow up

Time frame
10 years
3

Percentage of patients died at 10 years

Evaluation of Overall Survival (OS): Percentage of patients died at 10 years

Time frame
10 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

European Institute of Oncology

Lead sponsor

Source ClinicalTrials.gov
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