NCT07695974

Brief Summary

The goal of this observational study is to identify demographic and clinicopathological factors associated with disease recurrence in adults with histologically confirmed papillary thyroid carcinoma (PTC) who achieved an initial disease-free status after primary treatment. The main questions it aims to answer are: Which demographic and clinicopathological characteristics are associated with an increased risk of PTC recurrence? Researchers will compare patients who developed biochemical or structural recurrence with those who remained recurrence-free to assess the prognostic role of age, sex, tumor size, histological subtype, vascular invasion, capsular invasion, gross invasion of the prethyroid strap muscles, concomitant thyroiditis, multifocality, lymph-node status, and pathological stage. As this is a retrospective study, participants will not undergo any study-specific intervention or additional procedure. Researchers will review existing demographic, surgical, pathological, treatment, and follow-up data from a prospectively maintained institutional database. Follow-up data include serial serum thyroglobulin measurements, neck ultrasonography, recurrence, and disease-specific mortality.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,113

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2000

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 7, 2000

Completed
18.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2018

Completed
5.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2024

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

July 5, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 10, 2026

Completed
Last Updated

July 10, 2026

Status Verified

July 1, 2026

Enrollment Period

18.7 years

First QC Date

July 5, 2026

Last Update Submit

July 5, 2026

Conditions

Recurrence Free SurvivalPapillary Thyroid Carcinoma

Keywords

Papillary thyroid carcinomaDisease recurrencePrognostic factorsRisk stratification5-year follow-up

Outcome Measures

Primary Outcomes (1)

  • Recurrence

    biochemical or structural evidence of disease arising after the achievement of an initial disease-free status.

    From surgery to the end of follow-up (minimum of 60 months)

Study Arms (2)

Disease-free

The disease-free group included patients who achieved an initial disease-free status after primary treatment and showed no biochemical or structural evidence of recurrence during follow-up.

With recurrence

The recurrence group included patients who achieved an initial disease-free status after primary treatment and subsequently developed documented biochemical or structural recurrence.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consisted of adult patients treated for histologically confirmed papillary thyroid carcinoma at the Department of Surgery of Sapienza University of Rome, Policlinico Umberto I Hospital, between 2000 and 2018. Patients were identified from a prospectively maintained institutional database and had undergone primary surgical treatment and subsequent postoperative surveillance at the same tertiary referral center.

You may qualify if:

  • histologically confirmed diagnosis of papillary thyroid carcinoma
  • no history of previous neck surgery
  • availability of complete clinical, pathological, treatment, and follow-up data;
  • achievement of an initial disease-free status after primary treatment
  • minimum follow-up of 60 months for patients who remained recurrence-free

You may not qualify if:

  • histological diagnosis other than papillary thyroid carcinoma
  • previous neck surgery
  • incomplete clinical, pathological, treatment, or follow-up records
  • follow-up shorter than 60 months in patients without recurrence
  • biochemical or structural evidence of persistent disease after initial treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sapienza University of Rome - Policlinico Umberto I Hospital

Roma, 00161, Italy

Location

MeSH Terms

Conditions

Thyroid Cancer, Papillary

Condition Hierarchy (Ancestors)

Adenocarcinoma, PapillaryAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsThyroid NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Study Officials

  • Eleonora Lori, MD

    University of Roma La Sapienza

    PRINCIPAL INVESTIGATOR

  • Salvatore Sorrenti, MD, PhD

    University of Roma La Sapienza

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 5, 2026

First Posted

July 10, 2026

Study Start

January 7, 2000

Primary Completion

August 31, 2018

Study Completion

January 15, 2024

Last Updated

July 10, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)