Prognostic Value of Tumor Deposits for Patients With Papillary Thyroid Carcinoma

NCT06051838 | Completed

• 1 other identifier: NFEC-2023-326
• Study Type: observational
• Target: 541
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Exploring the Prognostic Value of Tumor Deposits PTC Patients

Keywords

tumor deposits, extranodal extension, papillary thyroid carcinoma, lymph node metastasis, prognosis.

Outcome Measures

Primary Outcomes (1)

• disease-free survival (DFS) after diagnosis

  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 Outcomes (1)

• Disease recurrence

  between 2015 and 2021

Study Arms (2)

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.

Procedure: surgery

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.

Procedure: surgery

Interventions

surgery PROCEDURE

if the patients is TD positive, we recommond careful surgery and pathological examination.

Non-TD cohort; TD cohort

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• (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.

You may not qualify if:

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

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

Location

MeSH Terms

Conditions

Extranodal Extension; Thyroid Cancer, Papillary; Lymphatic Metastasis

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Neoplasm Metastasis; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adenocarcinoma, Papillary; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Thyroid Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Study Officials

• Shangtong Lei

  Nanfang Hospital, Southern Medical University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 18, 2023
• First Posted: September 25, 2023
• Study Start: November 1, 2022
• Primary Completion: February 28, 2023
• Study Completion: March 30, 2023
• Last Updated: September 25, 2023

Record last verified: 2023-09

Locations

CN (1)