Prognostic Value of Tumor Deposits for Patients With Papillary Thyroid Carcinoma

Sponsor
Nanfang Hospital, Southern Medical University (Other)
Overall Status
Completed
CT.gov ID
NCT06051838
Collaborator
(none)
541
1
4.9
110.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: surgery

Study Design

Study Type:
Observational
Actual Enrollment :
541 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Prognostic Value of Tumor Deposits for Patients With Papillary Thyroid Carcinoma: a Retrospective Cohort Study
Actual Study Start Date :
Nov 1, 2022
Actual Primary Completion Date :
Feb 28, 2023
Actual Study Completion Date :
Mar 30, 2023

Arms and Interventions

Arm 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.

Procedure: surgery
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.

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

Outcome Measures

Primary Outcome Measures

  1. disease-free survival (DFS) after diagnosis [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.

Secondary Outcome Measures

  1. Disease recurrence [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Nanfang Hospital, Southern Medical University Guangzhou Guangdong China 510515

Sponsors and Collaborators

  • Nanfang Hospital, Southern Medical University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nanfang Hospital, Southern Medical University
ClinicalTrials.gov Identifier:
NCT06051838
Other Study ID Numbers:
  • NFEC-2023-326
First Posted:
Sep 25, 2023
Last Update Posted:
Sep 25, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Nanfang Hospital, Southern Medical University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 25, 2023