NCT04336696

Brief Summary

study assigned into three groups, Group I was the control group operated by total thyroidectomy and retrospectively followed, where the other two groups Operated by Total thyroidectomy and central neck dissection. Recurrence Free Survival (RFS) was the main issue of the study and calculated as the time from date of surgery to date of relapse or the most recent follow-up contact that patient was known as relapse-free, Study exclusively studied the outcome and advantage of central neck dissection

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
199

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

November 2, 2016

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

April 1, 2020

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 3, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 7, 2020

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 3, 2020

Completed
Last Updated

April 7, 2020

Status Verified

April 1, 2020

Enrollment Period

3.4 years

First QC Date

April 1, 2020

Last Update Submit

April 2, 2020

Conditions

Papillary Thyroid Carcinoma

Keywords

papillary carcinomarecurrence of PTCRadio-iodine therapy for PTC

Outcome Measures

Primary Outcomes (1)

  • recurrence free survival

    recurrence free survival calculated from first day of diagnosis

    21 months

Study Arms (2)

Comparison between the studied groups regarding management.

ACTIVE COMPARATOR

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.

Procedure: Total thyroidectomy and central neck dissection

Recurrence free survival

OTHER

patients with total thyroidectomy only had shorter recurrence free survival

Procedure: Total thyroidectomy and central neck dissection

Interventions

Total thyroidectomy and central neck dissectionPROCEDURE
Comparison between the studied groups regarding management.Recurrence free survival

Eligibility Criteria

Age42 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age ≥20 years, Histopathology proved PTC, with no lymph nodes detected (N0)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zagazig University Hospitals

Zagazig, 13, Egypt

RECRUITING

Related Publications (2)

  • 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.

    PMID: 25590215RESULT

  • 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.

    PMID: 29750323RESULT

MeSH Terms

Conditions

Thyroid Cancer, PapillaryCarcinoma, Papillary

Condition Hierarchy (Ancestors)

Adenocarcinoma, PapillaryAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsThyroid NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteHead and Neck NeoplasmsEndocrine System DiseasesThyroid DiseasesNeoplasms, Squamous Cell

Central Study Contacts

Bassem M Sieda

CONTACT

drbassemmostafa@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
guuartor of study, only participant
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: prospective cohort study
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor of general surgery, Faculty of medicine

Study Record Dates

First Submitted

April 1, 2020

First Posted

April 7, 2020

Study Start

November 2, 2016

Primary Completion

April 3, 2020

Study Completion

May 3, 2020

Last Updated

April 7, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will share

after aprovel, recommendation of study will be shared with other researchers

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
1 year

Locations

EG(1)