Study of Clinical Outcomes of Thyroid Cancer

Recruiting

• Conditions: Thyroid Neoplasms

• Registration Number: NCT04031339
• Lead Sponsor: University of Roma La Sapienza

Brief Summary

The Italian Thyroid Cancer Observatory (ITCO) repository was established to collect data on thyroid cancer management in a prospective and consecutive series of newly-diagnosed patients, enrolled in centers uniformly distributed across the nation.

Detailed Description

Little information is available on current practices in the treatment of thyroid cancer: a web-based thyroid cancer database was created to collect real-life data. The participants' network include tertiary referral centers operating at the national level, as well as smaller hospital-based units with local or regional recruitment areas.

Study Timeline

• Study Start: 2013-01-01
• Study First Submitted: 2019-06-25
• Study First Submitted QC: 2019-07-23
• Study First Posted: 2019-07-24
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-08
• Last Update Posted: 2023-05-10
• Primary Completion: 2025-01
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15000

Inclusion Criteria

• pathologically confirmed thyroid cancer
• clinical follow-up including serum thyroglobulin (Tg) assays, circulating Tg antibodies, and high-resolution gray-scale and color Doppler US of the thyroid bed and cervical lymph node compartments. Additional imaging studies and/or fine-needle aspiration biopsy for cytology are ordered at the examiner's discretion in accordance with evidence-based guidelines
• entire follow-up at a participating clinical center.

Exclusion Criteria

• patients referred to the recruiting centers ≥12 months from the primary treatment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease persistence or recurrence	Up to 10 years from the primary treatment	Composite event of disease persistence or recurrence during clinical follow-up, detected by any of the available imaging tools (neck sonography, computed tomography \[CT\], magnetic resonance imaging \[MRI\], or positron emission tomography \[PET\])

Secondary Outcome Measures

Name	Time	Method
Response to primary therapy	1, 3, 5 and 10 years after therapy	Response to primary treatment, evaluated according to the American Thyroid Association guidelines response to treatment: excellent response, biochemical incomplete response, indeterminate response, or structural incomplete response (combination of serum tumor markers and imaging tools, such as neck sonography, radioiodine whole body scan, computed tomography \[CT\], magnetic resonance imaging \[MRI\], or positron emission tomography \[PET\])
Disease recurrence after 3, 5 and 10 years from the primary treatment	3, 5 and 10 years from the primary treatment	Rate of disease recurrence after 3, 5 and 10 years from the primary treatment, detected by any of the available imaging tools (neck sonography, radioiodine whole body scan, computed tomography \[CT\], magnetic resonance imaging \[MRI\], or positron emission tomography \[PET\])
Disease persistence after 12-18 months from the primary treatment	12-18 months from the primary treatment	Rate of disease persistence after 12-18 months from the primary treatment, detected by any of the available imaging tools (neck sonography, radioiodine whole body scan, computed tomography \[CT\], magnetic resonance imaging \[MRI\], or positron emission tomography \[PET\])
Response to secondary treatments	1, 3, 5 and 10 years after therapy	Response to secondary treatments, evaluated according to the American Thyroid Association guidelines response to treatment: excellent response, biochemical incomplete response, indeterminate response, or structural incomplete response (combination of serum tumor markers and imaging tools, such as neck sonography, radioiodine whole body scan, computed tomography \[CT\], magnetic resonance imaging \[MRI\], or positron emission tomography \[PET\])

Trial Locations

Locations (35)

A.S.S.T. Grande Ospedale Metropolitano Niguarda; 🇮🇹 Milan, Milano, Italy

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico; 🇮🇹 Milan, Milano, Italy

IRCCS Ospedale San Raffaele; 🇮🇹 Milan, Milano, Italy

Ospedale Regina Apostolorum; 🇮🇹 Albano Laziale, RM, Italy

Ospedali Riuniti di Ancona; 🇮🇹 Ancona, Italy

Università degli Studi di Bari; 🇮🇹 Bari, Italy

Ospedale degli Infermi di Biella; 🇮🇹 Biella, Italy

Azienda Unità Sanitaria di Bologna - Ospedale Maggiore; 🇮🇹 Bologna, Italy

University of Bologna, S. Orsola Malpighi Hospital; 🇮🇹 Bologna, Italy

Università degli Studi di Brescia, Spedali Civili; 🇮🇹 Brescia, Italy

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