Pediatric and Adolescent Differentiated Thyroid CarcinomaCPSO-TCNCT06592118
Clinical and Surgical Outcomes of Thyroid Carcinoma in Children and Adolescents
An observational study of Pediatric and Adolescent Differentiated Thyroid Carcinoma and SEER Database Analysis, run by Dezhou Hospital Qilu Hospital of Shandong University.
Trial summary
This study aims to investigate the differences in clinical characteristics, causes of death, long-term survival, and surgical approaches between pediatric and adolescent follicular and papillary carcinoma by exploring data from the SEER database. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Pediatric and Adolescent Differentiated Thyroid Carcinoma, SEER Database Analysis
- What is being tested?
- Different Pathological Types (FTC vs PTC)
- How many people
- 3,068 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2000to 31 Aug 2024
- 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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The study population consists of pediatric and adolescent patients, aged 1 to 18 years, who have been diagnosed with Follicular Thyroid Carcinoma (FTC) or Papillary Thyroid Carcinoma (PTC). These patients were identified from a comprehensive database containing clinical, pathological, and surgical records.The population spans a diverse demographic, representing various ethnicities, genders, and geographical locations. This cohort was selected to ensure a thorough investigation of the differences in clinical presentations, surgical outcomes, and prognostic factors between the two types of thyroid carcinoma within the pediatric and adolescent age groups.
Who may be able to join
- Pathologically confirmed diagnosis of Follicular Thyroid Carcinoma (FTC) or Papillary Thyroid Carcinoma (PTC).
- Age range: Pediatric and adolescent patients (ages 1-18 years).
Who cannot join
- Patients with incomplete survival and clinical information.
About this study
Official title: Clinical Profiles, Surgical Strategies, and Outcomes of Follicular and Papillary Thyroid Carcinoma in Pediatric and Adolescent Populations: A Retrospective Comparative Study
This study aims to investigate the differences in clinical characteristics, causes of death, long-term survival, and surgical approaches between pediatric and adolescent follicular and papillary carcinoma by exploring data from the SEER database. The research is designed as a retrospective cohort study, primarily focused on collecting and comparing data to identify key disparities and outcomes between these two patient groups. It is anticipated that the findings will provide valuable insights into the management and prognosis of these cancers in younger populations, contributing to more targeted and effective treatment strategies.
Read the detailed description
This study is a retrospective cohort analysis aimed at elucidating the differences between pediatric and adolescent patients diagnosed with follicular and [specific type] carcinoma, utilizing data sourced from the SEER (Surveillance, Epidemiology, and End Results) database. The focus of the research is on a comprehensive comparison of various clinical aspects, including demographic characteristics, tumor features, treatment modalities, and survival outcomes.
Key areas of investigation include the examination of clinical characteristics such as tumor size, location, and stage at diagnosis, as well as treatment approaches including surgery types and their impact on patient outcomes. Additionally, the study will assess the causes of death and overall survival rates among these young patients, aiming to identify any significant prognostic factors.
By leveraging the robust and extensive data available in the SEER database, this study seeks to uncover critical insights into the management of follicular and [specific type] carcinoma in pediatric and adolescent populations. The findings are expected to contribute to the development of more tailored and effective therapeutic strategies, ultimately improving long-term survival and quality of life for affected patients.
- Being tested
- Different Pathological Types (FTC vs PTC)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Different Pathological Types (FTC vs PTC)Other
Also called Different Pathological Types
Comprehensive Comparison of Pediatric and Adolescent Follicular Thyroid Carcinoma and Papillary Thyroid Carcinoma Patients
| Study group | Role | What they receive |
|---|---|---|
| FTC | Pediatric and Adolescent Patients with Follicular Thyroid Carcinoma Receives: Other: Different Pathological Types (FTC vs PTC) | |
| PTC | Pediatric and Adolescent Patients with Papillary Thyroid Carcinoma Receives: Other: Different Pathological Types (FTC vs PTC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Time from diagnosis until death from any cause.
Measured: Up to 20 years post-diagnosis
T (Tumor) - Primary Tumor
T describes the size and/or extent of the primary tumor, T values typically range from T0 to T4, where T0 indicates no evidence of a primary tumor (not detectable), and T4 indicates a large tumor that has significantly invaded surrounding tissues.
Measured: Perioperatively/Periprocedurally
N (Nodes) - Regional Lymph Nodes
The N staging will classify the extent of lymph node involvement as follows: N0 indicates no lymph node metastasis, N1a indicates metastasis to central compartment lymph nodes, and N1b indicates metastasis to lateral neck lymph nodes.
Measured: Perioperatively/Periprocedurally
M (Metastasis) - Distant Metastasis
M describes whether cancer has spread to other parts of the body (distant metastasis). M values are usually M0 or M1, where M0 indicates no distant metastasis, and M1 indicates the presence of distant metastasis.
Measured: Within one month after the diagnosis of thyroid carcinoma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Jan 2000
- Primary completion31 Dec 2020
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pediatric and Adolescent Differentiated Thyroid CarcinomaStudies of the same condition, open and under way.
- 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
- 3,068 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dezhou Hospital Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tao Zhang, MD, Study director, Qilu Hospital of Shandong University Dezhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06592118
- Sponsor's protocol ID
- DZSRMYYZC2024095
- Acronym
- CPSO-TC
- Status last verified
- Sep 2024
- First submitted
- 4 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Yes, individual participant data (IPD) will be made available to other researchers under a formal data-sharing agreement.
Publications
Cistaro A, Quartuccio N, Garganese MC, Villani MF, Altini C, Pizzoferro M, Piccardo A, Cabria M, Massollo M, Maghnie M, Campenni A, Siracusa M, Baldari S, Panareo S, Urso L, Bartolomei M, De Palma D, Grossi A, Mazzoletti A, Dondi F, Bertagna F, Giubbini R, Albano D. Prognostic factors in children and adolescents with differentiated thyroid carcinoma treated with total thyroidectomy and RAI: a real-life multicentric study. Eur J Nucl Med Mol Imaging. 2022 Mar;49(4):1374-1385. doi: 10.1007/s00259-021-05586-8. Epub 2021 Oct 19.
PubMed 34664092de Souza Reis R, Gatta G, de Camargo B. Thyroid carcinoma in children, adolescents, and young adults in Brazil: A report from 11 population-based cancer registries. PLoS One. 2020 May 1;15(5):e0232416. doi: 10.1371/journal.pone.0232416. eCollection 2020.
PubMed 32357198Moleti M, Aversa T, Crisafulli S, Trifiro G, Corica D, Pepe G, Cannavo L, Di Mauro M, Paola G, Fontana A, Calapai F, Cannavo S, Wasniewska M. Global incidence and prevalence of differentiated thyroid cancer in childhood: systematic review and meta-analysis. Front Endocrinol (Lausanne). 2023 Sep 19;14:1270518. doi: 10.3389/fendo.2023.1270518. eCollection 2023.
PubMed 37795368Liu Y, Meng T, Ma S, Zheng Y, Miao Y, Zhang T. Clinical characteristics, surgical approaches, and prognosis of follicular and papillary thyroid cancer in children and adolescents: a retrospective cohort study. Pediatr Surg Int. 2025 Feb 28;41(1):89. doi: 10.1007/s00383-025-05990-3.
PubMed 40019558
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Profiles, Surgical Strategies, and Outcomes of Follicular and Papillary Thyroid Carcinoma in Pediatric and Adolescent Populations: A Retrospective Comparative Study
- ClinicalTrials.gov ID
- NCT06592118
- Acronym / sponsor ID
- CPSO-TC / DZSRMYYZC2024095
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,068 participants (actual)
- Lead sponsor
- Dezhou Hospital Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 1 Jan 2000 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 19 Sep 2024 (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.
This study aims to investigate the differences in clinical characteristics, causes of death, long-term survival, and surgical approaches between pediatric and adolescent follicular and papillary carcinoma by exploring data from the SEER database. The research is designed as a retrospective cohort study, primarily focused on collecting and comparing data to identify key disparities and outcomes between these two patient groups. It is anticipated that the findings will provide valuable insights into the management and prognosis of these cancers in younger populations, contributing to more targeted and effective treatment strategies.
Detailed description
This study is a retrospective cohort analysis aimed at elucidating the differences between pediatric and adolescent patients diagnosed with follicular and [specific type] carcinoma, utilizing data sourced from the SEER (Surveillance, Epidemiology, and End Results) database. The focus of the research is on a comprehensive comparison of various clinical aspects, including demographic characteristics, tumor features, treatment modalities, and survival outcomes.
Key areas of investigation include the examination of clinical characteristics such as tumor size, location, and stage at diagnosis, as well as treatment approaches including surgery types and their impact on patient outcomes. Additionally, the study will assess the causes of death and overall survival rates among these young patients, aiming to identify any significant prognostic factors.
By leveraging the robust and extensive data available in the SEER database, this study seeks to uncover critical insights into the management of follicular and [specific type] carcinoma in pediatric and adolescent populations. The findings are expected to contribute to the development of more tailored and effective therapeutic strategies, ultimately improving long-term survival and quality of life for affected patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FTC | – | Other: Different Pathological Types (FTC vs PTC)Pediatric and Adolescent Patients with Follicular Thyroid Carcinoma |
| PTC | – | Other: Different Pathological Types (FTC vs PTC)Pediatric and Adolescent Patients with Papillary Thyroid Carcinoma |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study population consists of pediatric and adolescent patients, aged 1 to 18 years, who have been diagnosed with Follicular Thyroid Carcinoma (FTC) or Papillary Thyroid Carcinoma (PTC). These patients were identified from a comprehensive database containing clinical, pathological, and surgical records.The population spans a diverse demographic, representing various ethnicities, genders, and geographical locations. This cohort was selected to ensure a thorough investigation of the differences in clinical presentations, surgical outcomes, and prognostic factors between the two types of thyroid carcinoma within the pediatric and adolescent age groups.
Key inclusion criteria (2 listed)
- Pathologically confirmed diagnosis of Follicular Thyroid Carcinoma (FTC) or Papillary Thyroid Carcinoma (PTC).
- Age range: Pediatric and adolescent patients (ages 1-18 years).
Key exclusion criteria (1 listed)
- Patients with incomplete survival and clinical information.
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 |
|---|---|---|
| Different Pathological Types (FTC vs PTC)Also: Different Pathological TypesComprehensive Comparison of Pediatric and Adolescent Follicular Thyroid Carcinoma and Papillary Thyroid Carcinoma Patients | Other | FTC, PTC |
Primary outcome
Overall Survival (OS)
Time frame: Up to 20 years post-diagnosis
Time from diagnosis until death from any cause.
T (Tumor) - Primary Tumor
Time frame: Perioperatively/Periprocedurally
T describes the size and/or extent of the primary tumor, T values typically range from T0 to T4, where T0 indicates no evidence of a primary tumor (not detectable), and T4 indicates a large tumor that has significantly invaded surrounding tissues.
N (Nodes) - Regional Lymph Nodes
Time frame: Perioperatively/Periprocedurally
The N staging will classify the extent of lymph node involvement as follows: N0 indicates no lymph node metastasis, N1a indicates metastasis to central compartment lymph nodes, and N1b indicates metastasis to lateral neck lymph nodes.
M (Metastasis) - Distant Metastasis
Time frame: Within one month after the diagnosis of thyroid carcinoma
M describes whether cancer has spread to other parts of the body (distant metastasis). M values are usually M0 or M1, where M0 indicates no distant metastasis, and M1 indicates the presence of distant metastasis.
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 19 Sep 2024.
- Background: PubMed 34664092Cistaro A, Quartuccio N, Garganese MC, Villani MF, Altini C, Pizzoferro M, Piccardo A, Cabria M, Massollo M, Maghnie M, Campenni A, Siracusa M, Baldari S, Panareo S, Urso L, Bartolomei M, De Palma D, Grossi A, Mazzoletti A, Dondi F, Bertagna F, Giubbini R, Albano D. Prognostic factors in children and adolescents with differentiated thyroid carcinoma treated with total thyroidectomy and RAI: a real-life multicentric study. Eur J Nucl Med Mol Imaging. 2022 Mar;49(4):1374-1385. doi: 10.1007/s00259-021-05586-8. Epub 2021 Oct 19.
- Background: PubMed 32357198de Souza Reis R, Gatta G, de Camargo B. Thyroid carcinoma in children, adolescents, and young adults in Brazil: A report from 11 population-based cancer registries. PLoS One. 2020 May 1;15(5):e0232416. doi: 10.1371/journal.pone.0232416. eCollection 2020.
- Background: PubMed 37795368Moleti M, Aversa T, Crisafulli S, Trifiro G, Corica D, Pepe G, Cannavo L, Di Mauro M, Paola G, Fontana A, Calapai F, Cannavo S, Wasniewska M. Global incidence and prevalence of differentiated thyroid cancer in childhood: systematic review and meta-analysis. Front Endocrinol (Lausanne). 2023 Sep 19;14:1270518. doi: 10.3389/fendo.2023.1270518. eCollection 2023.
- Derived from this study: PubMed 40019558Liu Y, Meng T, Ma S, Zheng Y, Miao Y, Zhang T. Clinical characteristics, surgical approaches, and prognosis of follicular and papillary thyroid cancer in children and adolescents: a retrospective cohort study. Pediatr Surg Int. 2025 Feb 28;41(1):89. doi: 10.1007/s00383-025-05990-3.
- Individual participant dataSharing planned: Yes. Yes, individual participant data (IPD) will be made available to other researchers under a formal data-sharing agreement.
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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.
Tao Zhang, MD study director
Qilu Hospital of Shandong University Dezhou
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric and Adolescent Differentiated Thyroid Carcinoma and SEER Database Analysis, run by Dezhou Hospital Qilu Hospital of Shandong University.
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 2 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Overall Survival (OS) (time frame: Up to 20 years post-diagnosis). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06592118, which also lists 4 linked publications.
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 19 Sep 2024.