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OpenTrials
Completed

NCT Number: NCT06051838

Prognostic Value of Tumor Deposits for Patients With Papillary Thyroid Carcinoma

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Surgery

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Nanfang Hospital, Southern Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 25, 2023
Registry last updated
Sep 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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