Active Surveillance Versus Surgery in Thyroid Papillary Microcarcinoma
NCT ID: NCT04129281
Last Updated: 2023-03-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2019-01-23
2024-02-23
Brief Summary
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Detailed Description
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A further objective is to identify events associated with high risk of local recurrence and distant metastases.
Patients will be randomized to surgery or active surveillance. Patients who refuse the randomization process will be followed according to the treatment choice according to clinical practice.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Surgery
Surgery
Surgery
Surgery acconding to clinical practice
Active surveillance
Follow up
No interventions assigned to this group
Interventions
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Surgery
Surgery acconding to clinical practice
Eligibility Criteria
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Inclusion Criteria
* Suspicious nodule \< or = or 13 mm in the maximum size of thyroid ultrasound (not older than 3 months after the screening visit)
* Cytology consistent with the TIR4 or TIR 5 class
* Sieric TSH in th standard range (with or without levo-tyroxin therapy)
* Normal string motility to fibrolaringoscopy
* Written informed consent
Exclusion Criteria
* Calcitonin increase above normal levels
* Clinical or instrumental evidence of locoregional lymph node metastases (central or laterocervical compartment) or remote
* any Contraindications to surgery
18 Years
ALL
No
Sponsors
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National Cancer Institute, Naples
OTHER
Responsible Party
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Principal Investigators
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Luciano Pezzullo
Role: PRINCIPAL_INVESTIGATOR
IRCCS Study Principal Investigator
Locations
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Istitute Nazionale Tumori - Fondazione G. Pascale
Napoli, , Italy
Countries
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Central Contacts
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Other Identifiers
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MITICA
Identifier Type: -
Identifier Source: org_study_id
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