Observational Study on Thyroid Tumors and EvaLuation of the roLe of New pOntential Predictive/Prognostic Factors

NCT07064369 | Enrolling By Invitation

• 1 other identifier: 6506
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The OTELLO Study is a monocentric, ambispective observational study that systematically analyzes the clinical, laboratory, anatomopathological, and molecular characteristics of patients with thyroid neoplasms treated at the Agostino Gemelli University Hospital - IRCCS. Study Objectives The primary goal is to identify prognostic and predictive factors that can enhance the clinical and therapeutic management of thyroid cancer patients at any disease stage. The analysis aims to integrate biological tumor characteristics with clinical and therapeutic data to identify significant correlations between these parameters and disease progression. Study Design and Patient Cohorts The study includes two distinct cohorts: Historical (retrospective) cohort: This group includes patients previously treated for thyroid neoplasms from January 1, 2010, to the date of study approval. Data from these patients will be analyzed to evaluate long-term outcomes and identify potential predictors of treatment response. Prospective cohort: This group includes patients newly diagnosed with thyroid cancer who will be enrolled over a 60-month period from the study's approval. These patients will undergo systematic monitoring to assess disease progression and therapy effectiveness. Data Collection and Analysis The study will collect and examine data on: Clinical characteristics: Including sex, age at diagnosis, comorbidities, hereditary syndromes, and performance status. Laboratory data: Including tumor markers and metabolic parameters relevant to disease characterization. Anatomopathological aspects: Such as histological tumor type, pathological staging, lymphovascular or perineural invasion, and other indicators of tumor aggressiveness. Molecular profiles: Evaluated through genetic alterations and biomarkers with potential prognostic and predictive value. Statistical and Methodological Approach An advanced statistical approach will be used to assess the impact of collected variables on patient outcomes. The analysis will include: Comparative analyses of patient groups based on clinical and biological characteristics. Survival analysis, estimating overall survival (OS) and progression-free survival (PFS) using Kaplan-Meier curves and log-rank tests. Multivariate regression models to identify independent factors associated with prognosis and treatment response. Ethical Considerations and Regulatory Compliance The study will be conducted in compliance with ethical and regulatory guidelines, including the Declaration of Helsinki, Good Clinical Practice (GCP) by ICH, and Italian regulations on observational studies. Patient data will be anonymized and securely stored, ensuring confidentiality. As a non-interventional study, no experimental drugs or procedures will be administered. However, molecular and immunohistochemical analyses will be performed on tumor tissue samples already available or collected during standard clinical practice. Study Timeline and Expected Outcomes The prospective cohort enrollment will continue until 2029, after which statistical analyses will be completed, and study results will be published. The collected data will provide valuable insights for optimizing the clinical management of thyroid cancer patients, supporting the development of increasingly personalized diagnostic and therapeutic strategies.

Conditions

Carcinoma of Head/Neck

Keywords

thyroid; thyroid carcinoma

Outcome Measures

Primary Outcomes (1)

• overall survival

  The time interval (expressed in months) between the date of disease diagnosis and the date of death from any cause. For patients who have not experienced an event by the date of the last follow-up, the observation period will be censored at that date.

  February 2025 - September 2029

Secondary Outcomes (1)

• DoR, PFS, RR, DCR, Tolerability

  February 2025 - September 2029

Study Arms (2)

Historical (Retrospective) Cohort

The medical records of patients diagnosed with thyroid neoplasms and followed at the Medical Oncology Unit of the Fondazione Policlinico Universitario Agostino Gemelli (FPG) - IRCCS from January 1, 2010, until the date of study approval will be screened for retrospective analysis. Cases that meet the inclusion and exclusion criteria will be selected, and their medical records will be reviewed by the investigators to collect the required information. For patients who are still alive, they will be contacted to discuss the study and, if they agree to participate, they will be asked to sign the informed consent (IC) and the data privacy consent form

Prospective Cohort

Patients diagnosed with thyroid neoplasms who present to the Medical Oncology Unit of the Fondazione Policlinico Universitario Agostino Gemelli (FPG) - IRCCS after the protocol approval date and within the following 60 months will be screened. If they meet the inclusion and exclusion criteria, they will be enrolled in the study after signing the informed consent (IC) and the data privacy consent form.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of patients diagnosed with thyroid neoplasms who are being followed at the Medical Oncology Unit of the Fondazione Policlinico Universitario Agostino Gemelli (FPG) - IRCCS. The study includes both a historical (retrospective) cohort and a prospective cohort. Retrospective Cohort: All patients diagnosed with thyroid cancer or who initiated treatment for thyroid cancer at the Medical Oncology Unit of FPG - IRCCS between January 1, 2010, and the date of study approval will be screened for enrollment. Prospective Cohort: All patients who receive a thyroid cancer diagnosis or initiate treatment at the Medical Oncology Unit of FPG - IRCCS during the 60 months following the study approval date will be screened for enrollment.

You may qualify if:

• Histological diagnosis of thyroid neoplasm, any subtype.
• Age ≥ 18 years.
• Signed informed consent (IC) for living patients.
• Signed data privacy consent for living patients.
• At least one follow-up visit after the initial oncology consultation.

You may not qualify if:

• Lack of clinical data sufficient to determine survival (primary endpoint of the study).
• Absence of a histological diagnosis.
• Failure to sign the informed consent.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS - UCSC

Roma, Italy

Location

Related Publications (1)

• Sumana BS, Shashidhar S, Shivarudrappa AS. Galectin-3 Immunohistochemical Expression in Thyroid Neoplasms. J Clin Diagn Res. 2015 Nov;9(11):EC07-11. doi: 10.7860/JCDR/2015/16277.6760. Epub 2015 Nov 1.

  PMID: 26673516 BACKGROUND

MeSH Terms

Conditions

Thyroid Diseases; Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine System Diseases; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms

Study Officials

• Giovanni Schinzari, Prof

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: July 14, 2025
• Study Start: February 28, 2025
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: July 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)