Exploring the Prognostic Value of Tumor Deposits PTC PatientsNCT06051838
Prognostic Value of Tumor Deposits for Patients With Papillary Thyroid Carcinoma
An observational study of Exploring the Prognostic Value of Tumor Deposits PTC Patients, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Exploring the Prognostic Value of Tumor Deposits PTC Patients
- What is being tested?
- surgery
- Type of treatment
- Surgery or procedure
- How many people
- 541 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2022to 30 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- patients with previous history of neck irradiation or other systematic cancers; (2) patients died of unrelated diseases.
Trial locations and contacts
1 site in 1 country.
China1 site
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
About this study
Official title: 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.
- Being tested
- surgery
- Keywords
- tumor deposits, extranodal extension, papillary thyroid carcinoma, lymph node metastasis, prognosis.
- Medical subject headings
- Extranodal Extension, Thyroid Cancer, Papillary, Lymphatic Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgeryProcedure or surgery
if the patients is TD positive, we recommond careful surgery and pathological examination.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: between 2015 and 2021
Secondary outcomes (1)
Disease recurrence
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.
Measured: between 2015 and 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start1 Nov 2022
- Primary completion28 Feb 2023
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exploring the Prognostic Value of Tumor Deposits PTC PatientsStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 541 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shangtong Lei, Principal investigator, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06051838
- Sponsor's protocol ID
- NFEC-2023-326
- Status last verified
- Sep 2023
- First submitted
- 18 Sep 2023
- Last updated
- 25 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Tumor Deposits for Patients With Papillary Thyroid Carcinoma: a Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT06051838
- Acronym / sponsor ID
- NFEC-2023-326
- Keywords
- tumor deposits, extranodal extension, papillary thyroid carcinoma, lymph node metastasis, prognosis.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 541 participants (actual)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 25 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TD cohort | – | Procedure: surgeryTumor 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. |
| Non-TD cohort | – | Procedure: surgeryTumor 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- patients with previous history of neck irradiation or other systematic cancers; (2) patients died of unrelated diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surgeryif the patients is TD positive, we recommond careful surgery and pathological examination. | Procedure or surgery | Non-TD cohort, TD cohort |
Primary outcome
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.
1 secondary outcome
Disease recurrence
Time frame: between 2015 and 2021
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2023.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shangtong Lei principal investigator
Nanfang Hospital, Southern Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Exploring the Prognostic Value of Tumor Deposits PTC Patients, run by Nanfang Hospital, Southern Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disease-free survival (DFS) after diagnosis (time frame: between 2015 and 2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2023.