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Study of Clinical Outcomes of Thyroid Cancer

Multicenter, Prospective, Observational Study of Clinical Outcomes of Thyroid Cancer

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04031339
Acronym
ITCO
Enrollment
15000
Registered
2019-07-24
Start date
2013-01-01
Completion date
2025-01-31
Last updated
2023-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroid Neoplasms

Keywords

papillary thyroid cancer, follicular thyroid cancer, poorly differentiated thyroid cancer, anaplastic thyroid cancer, medullary thyroid cancer

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.

Interventions

PROCEDUREStandard treatment

e.g., surgery, radioiodine therapy, systemic treatments (multikinase inhibitors), surveillance

Sponsors

Italian Thyroid Cancer Observatory (ITCO) Foundation
CollaboratorUNKNOWN
Catholic University of the Sacred Heart
CollaboratorOTHER
University of Roma La Sapienza
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Disease persistence or recurrenceUp to 10 years from the primary treatmentComposite 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

MeasureTime frameDescription
Disease persistence after 12-18 months from the primary treatment12-18 months from the primary treatmentRate 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 \[PET\])
Disease recurrence after 3, 5 and 10 years from the primary treatment3, 5 and 10 years from the primary treatmentRate 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 \[PET\])
Response to primary therapy1, 3, 5 and 10 years after therapyResponse 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 \[PET\])
Response to secondary treatments1, 3, 5 and 10 years after therapyResponse 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 \[PET\])

Countries

Italy

Contacts

Primary ContactCosimo Durante, MD,PhD
cosimo.durante@uniroma1.it
Backup ContactGiorgio Grani, MD,PhD
giorgio.grani@uniroma1.it

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026