- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04336696
Is Routine Dissection of Central Lymph Node Necessary for Papillary Thyroid Carcinoma, T1-2 N0?
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
informed consent taken, study was a prospective cohort study, with controlled group a retrospectively. patients ablated by total thyroidectomy only who failed to achieve ablation with the first dose of iodine 131I may be dynamically risk stratified as high-risk category and managed aggressively. N0 patients will benefit and ablated by total thyroidectomy and prophylactic central neck dissection, PCND decreases the residual, increase the RFS and patients without residual do not need adjuvant RAI therapy except in high risk group. Histological grading, size of the primary tumour, the extension of PTC, the extent of surgery were found to be a strong predicting factor for recurrence-free survival
Locoregional recurrence cases always found more in male patients aged more than 45 years old. Size of the primary tumour and the extent of surgery was a significant factor for RFS,
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Bassem M Sieda
- Email: drbassemmostafa@yahoo.com
Study Locations
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Zagazig, Egypt, 13
- Recruiting
- Zagazig University Hospitals
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Contact:
- Bassem M Sieda
- Email: drbassemmostafa@yahoo.com
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Contact:
- Bassem M Sieda, phd
- Phone Number: 00966541900039
- Email: drbassemmostafa@yahoo.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age ≥20 years, Histopathology proved PTC, with no lymph nodes detected (N0)
Exclusion Criteria:
- Younger age ≤20 years. Prior thyroidectomy, previous radiation exposure, postoperative radioactive iodine therapy, Histopathology report of any type of malignancy other than PTC or patients did not complete their postoperative follow-up period. PTC With N1 or N2
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Comparison between the studied groups regarding management.
The postoperative RAI scan after 1 month, showed a positive residual tumour in lateral LN in 70 patients in the controlled group and 13 patients in Group II, 8 patients in group III.
In group I, Patients with residuals were submitted to RAI ablation.
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Other: Recurrence free survival
patients with total thyroidectomy only had shorter recurrence free survival
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
recurrence free survival
Time Frame: 21 months
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recurrence free survival calculated from first day of diagnosis
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21 months
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Viola D, Materazzi G, Valerio L, Molinaro E, Agate L, Faviana P, Seccia V, Sensi E, Romei C, Piaggi P, Torregrossa L, Sellari-Franceschini S, Basolo F, Vitti P, Elisei R, Miccoli P. Prophylactic central compartment lymph node dissection in papillary thyroid carcinoma: clinical implications derived from the first prospective randomized controlled single institution study. J Clin Endocrinol Metab. 2015 Apr;100(4):1316-24. doi: 10.1210/jc.2014-3825. Epub 2015 Jan 15.
- Kim K, Kim JH, Park IS, Rho YS, Kwon GH, Lee DJ. The Updated AJCC/TNM Staging System for Papillary Thyroid Cancer (8th Edition): From the Perspective of Genomic Analysis. World J Surg. 2018 Nov;42(11):3624-3631. doi: 10.1007/s00268-018-4662-2.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0000-0002-9836-9580
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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