- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06051838
Prognostic Value of Tumor Deposits for Patients With Papillary Thyroid Carcinoma
Prognostic Value of Tumor Deposits for Patients With Papillary Thyroid Carcinoma: a Retrospective Cohort Study
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510515
- Nanfang Hospital, Southern Medical University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
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
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
Investigators
- Principal Investigator: Shangtong Lei, Nanfang Hospital, Southern Medical University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Endocrine System Diseases
- Endocrine Gland Neoplasms
- Thyroid Diseases
- Head and Neck Neoplasms
- Neoplastic Processes
- Neoplasm Metastasis
- Adenocarcinoma, Papillary
- Carcinoma
- Thyroid Neoplasms
- Thyroid Cancer, Papillary
- Extranodal Extension
Other Study ID Numbers
- NFEC-2023-326
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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