Prognostic Value of Tumor Deposits for Patients With Papillary Thyroid Carcinoma

September 18, 2023 updated by: Nanfang Hospital, Southern Medical University

Prognostic Value of Tumor Deposits for Patients With Papillary Thyroid Carcinoma: a Retrospective Cohort Study

Tumor deposits (TD), nodules in the peritumoral adipose tissue with no architectural residue of lymph node, which is a definition often being confusing to the extranodal extension (ENE), have been described in several malignancies and linked to a worse prognosis. In gastric cancer and colon cancer, TD and ENE should be distinguished and collected separately in 8th AJCC manual. However, in thyroid cancer, TD as a collection variable was absence in both the 8th AJCC manual and the 2015 ATA guideline. This is a study that revealed the presence of TD by reviewing a large number of papillary thyroid carcinoma (PTC) specimens and explored its prognostic value by constructing a nomogram to accurately predict disease-free survival in PTC patients.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

541

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Nanfang Hospital, Southern Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Five hundred and forty-one PTC patients were enrolled in this study. Their clinicopathological characteristics are shown in Table 1. The study population consisted of 186 (34.4%) males and 355 (65.6%) females, with median (IQR) age of 40 [31 to 50]. Of the patients, 13.3% were older than 55 years old. Median follow-up time after surgery was 35 months (IQR, 27 to 42 months).

TD was identified in 87 (16.1%) patients (TD-positive cohort). The rest of patients (n = 454, 83.9%) were not found with TD (Non-TD cohort). Female proportion was smaller in the TD positive cohort than in Non-TD cohort (51.7% vs 68.3%; p = 0.009). TD cohort has a higher proportion of age over 55 years than Non-TD cohort (20.7% vs 11.9%, p = 0.041). No differences in body mass index (BMI) (23.03 vs 23.22 kg/m2, p = 0.221) was observed between the TD cohort and Non-TD cohort.

Description

Inclusion Criteria:

(1) patients with histopathologically confirmed PTC and sections stored in the pathology department; (2) patients underwent lobectomy or total thyroidectomy and central lymph node dissection with or without lateral neck dissection; (3) patients cooperated to provide follow-up information after surgery.

Exclusion Criteria:

(1) patients with previous history of neck irradiation or other systematic cancers; (2) patients died of unrelated diseases.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
TD cohort
Tumor deposits (TD) positive group, which was determinded by the pathologists at department of pathology. Any tumor mass, either circumscribed or with irregular contours, devoid of lymph node architecture was identified as a tumor deposit.
if the patients is TD positive, we recommond careful surgery and pathological examination.
Non-TD cohort
Tumor deposits (TD) negative group, which was determinded by the pathologists at department of pathology. No visiblet umor mass, either circumscribed or with irregular contours, devoid of lymph node architecture in the sections of specimens from these patients.
if the patients is TD positive, we recommond careful surgery and pathological examination.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
disease-free survival (DFS) after diagnosis
Time Frame: between 2015 and 2021
The primary outcome was disease-free survival (DFS) after diagnosis, with endpoints as tumor locoregional recurrence, distant metastasis, and disease-specific death. If a patient was deceased, the cause of death was confirmed by the death certificate or the hospitalization record to identify disease-specific death.
between 2015 and 2021

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease recurrence
Time Frame: between 2015 and 2021
Disease recurrence was defined as recurrent or persistent PTC identified with standard biochemical, cytological, histological, and radiographical criteria. In this study, tumor locoregional recurrence was defined as combined biochemical (serum thyroglobulin) and structural recurrences.
between 2015 and 2021

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Shangtong Lei, Nanfang Hospital, Southern Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2022

Primary Completion (Actual)

February 28, 2023

Study Completion (Actual)

March 30, 2023

Study Registration Dates

First Submitted

September 18, 2023

First Submitted That Met QC Criteria

September 18, 2023

First Posted (Actual)

September 25, 2023

Study Record Updates

Last Update Posted (Actual)

September 25, 2023

Last Update Submitted That Met QC Criteria

September 18, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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