NCT06154863

Brief Summary

The aim of this study is to assess the recurrence-free survival (RFS) rate and recurrence-related factors, especially the relationship between RFS and RAI dose, in patients who received RAI after thyroidectomy.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 22, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 4, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

1 year

First QC Date

November 22, 2023

Last Update Submit

February 16, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Assessment of recurrence-free survival after RAI therapy in patients with thyroid cancer.

    Assessment of recurrence-free survival after radioactive iodine-131 therapy in patients with differentiated thyroid carcinoma.

    2 years

Secondary Outcomes (1)

  • Correlation analysis of I-131 SPECT/CT uptake parameters with the success ablation treatment of thyroid remnant.

    2 years

Other Outcomes (3)

  • Assessment of Prognostic significance of pathological data post thyroidectomy in thyroid cancer.

    2 years

  • Assessment of Prognostic significance of anti-thyroglobulin level in differentiated thyroid cancer.

    2 years

  • Assessment of Prognostic significance of thyroglobulin level in differentiated thyroid cancer.

    2 years

Interventions

RAIDRUG

Radioactive iodine

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients with differentiated thyroid cancer underwent total thyroidectomy.

You may qualify if:

  • Patients with DTC (differentiated thyroid cancer) who underwent total or subtotal thyroidectomy without distant metastasis and gross residual tumors.
  • Followed by ablation with RAI and underwent post RAI whole body scan.
  • Having baseline TG (thyroglobulin), Anti-TG antibodies (anti thyroglobulin) and neck US.
  • Patients with lymph node metastasis will be included if their lymph nodes had been dissected and no unresectable disease remained.

You may not qualify if:

  • Patients who received RAI and missed follow-up.
  • Patients with no surgical or pathological data.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Vigneri R, Malandrino P, Vigneri P. The changing epidemiology of thyroid cancer: why is incidence increasing? Curr Opin Oncol. 2015 Jan;27(1):1-7. doi: 10.1097/CCO.0000000000000148.

    PMID: 25310641BACKGROUND
  • Sawka AM, Carty SE, Haugen BR, Hennessey JV, Kopp PA, Pearce EN, Sosa JA, Tufano RP, Jonklaas J. American Thyroid Association Guidelines and Statements: Past, Present, and Future. Thyroid. 2018 Jun;28(6):692-706. doi: 10.1089/thy.2018.0070. Epub 2018 Apr 26.

    PMID: 29698130BACKGROUND
  • Ruel E, Thomas S, Dinan M, Perkins JM, Roman SA, Sosa JA. Adjuvant radioactive iodine therapy is associated with improved survival for patients with intermediate-risk papillary thyroid cancer. J Clin Endocrinol Metab. 2015 Apr;100(4):1529-36. doi: 10.1210/jc.2014-4332. Epub 2015 Feb 2.

    PMID: 25642591BACKGROUND
  • Jeong SY, Lee SW, Kim WW, Jung JH, Lee WK, Ahn BC, Lee J. Clinical outcomes of patients with T4 or N1b well-differentiated thyroid cancer after different strategies of adjuvant radioiodine therapy. Sci Rep. 2019 Apr 3;9(1):5570. doi: 10.1038/s41598-019-42083-3.

    PMID: 30944403BACKGROUND
  • Lee SH, Roh JL, Gong G, Cho KJ, Choi SH, Nam SY, Kim SY. Risk Factors for Recurrence After Treatment of N1b Papillary Thyroid Carcinoma. Ann Surg. 2019 May;269(5):966-971. doi: 10.1097/SLA.0000000000002710.

    PMID: 29462007BACKGROUND

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 22, 2023

First Posted

December 4, 2023

Study Start

March 1, 2024

Primary Completion

March 1, 2025

Study Completion

March 1, 2026

Last Updated

February 20, 2024

Record last verified: 2024-02