THY-CANC: Impact of Conventional Treatments and Clinical Variables on Thyroid Cancer

Sponsor

Istituto Auxologico Italiano (Other)

Overall Status

Recruiting

CT.gov ID

NCT05752604

Collaborator

(none)

3,000

Enrollment

Location

235.9

Anticipated Duration (Months)

12.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

DTC has a generally favorable prognosis. The possibility to discriminate between patients with aggressive tumors and those with a more indolent behavior may reduce the need for unnecessary treatments. Aim of this observational study is to evaluate how anamnestic, clinical, and histopathological variables may influence the outcome of the enrolled patients, both regarding morbidity and mortality and in terms of therapeutic choices. The study aims to evaluate the prognostic impact of the therapeutic interventions in terms of efficacy and regarding the appearance of adverse events.

Condition or Disease	Intervention/Treatment	Phase
Thyroid Cancer

Study Design

Study Type:

Observational

Anticipated Enrollment :

3000 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Retrospective and Prospective Evaluation of the Impact of Innovative and Conventional Treatments and of Clinical Variables on the Outcome of Thyroid Cancer

Actual Study Start Date :

Jul 12, 2022

Anticipated Primary Completion Date :

Mar 8, 2032

Anticipated Study Completion Date :

Mar 8, 2042

Outcome Measures

Primary Outcome Measures

Dynamic risk stratification [one year from the primary treatment]
impact of the different variables on the DRS
Dynamic risk stratification [five years from the primary treatment]
impact of the different variables on the DRS
Dynamic risk stratification [ten years from the primary treatment]
impact of the different variables on the DRS
Progression-free survival [one year from the primary treatment]
impact of the different variables on the PFS in patients treated with TKI for advanced thyroid cancer
Progression-free survival [five years from the primary treatment]
impact of the different variables on the PFS in patients treated with TKI for advanced thyroid cancer
Progression-free survival [ten years from the primary treatment]
impact of the different variables on the PFS in patients treated with TKI for advanced thyroid cancer
Overall survival [one year from the primary treatment]
impact of the different variables on the OS in patients treated with TKI for advanced thyroid cancer
Overall survival [five years from the primary treatment]
impact of the different variables on the OS in patients treated with TKI for advanced thyroid cancer
Overall survival [ten years from the primary treatment]
impact of the different variables on the OS in patients treated with TKI for advanced thyroid cancer

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

thyroid cancer diagnosis

Exclusion Criteria:

patients unable to sign informed consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Istituto Auxologico Italiano, IRCCS	Milan		Italy	20149

Sponsors and Collaborators

Istituto Auxologico Italiano

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Istituto Auxologico Italiano

ClinicalTrials.gov Identifier:

NCT05752604

Other Study ID Numbers:

05C212

First Posted:

Mar 2, 2023

Last Update Posted:

Mar 2, 2023

Last Verified:

Feb 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Thyroid Neoplasms

Thyroid Diseases

Study Results

No Results Posted as of Mar 2, 2023