Papillary Thyroid CarcinomaNCT04336696
Is Routine Dissection of Central Lymph Node Necessary for Papillary Thyroid Carcinoma, T1-2 N0?
A study testing Total thyroidectomy and central neck dissection in people with Papillary Thyroid Carcinoma, run by Bassem Mohamed Sieda at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 42 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Papillary Thyroid Carcinoma
- What is being tested?
- Total thyroidectomy and central neck dissection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 199 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Nov 2016to 3 May 2020
- Phase
- Interventional
- 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 42 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age ≥20 years, Histopathology proved PTC, with no lymph nodes detected (N0)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Bassem M Sieda contact
Egypt1 site, 1 recruiting
- Recruiting
Zagazig University Hospitals
Zagazig, 13
Bassem M Sieda, phd, 00966541900039, drbassemmostafa@yahoo.com
Bassem M Sieda, drbassemmostafa@yahoo.com
About this study
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
Read the 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,
- Conditions
- Papillary Thyroid Carcinoma
- Being tested
- Total thyroidectomy and central neck dissection
- Keywords
- papillary carcinoma, recurrence of PTC, Radio-iodine therapy for PTC
- Medical subject headings
- Thyroid Cancer, Papillary, Carcinoma, Papillary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total thyroidectomy and central neck dissectionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Total thyroidectomy and central neck dissection |
| Recurrence free survival | Other | patients with total thyroidectomy only had shorter recurrence free survival Receives: Procedure: Total thyroidectomy and central neck dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence free survival
recurrence free survival calculated from first day of diagnosis
Measured: 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2020
- Study start2 Nov 2016
- Primary completion3 Apr 2020 (estimated)
- Study completion3 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Papillary 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- prospective cohort study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 199 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bassem Mohamed Sieda
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Bassem Mohamed Sieda, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04336696
- Sponsor's protocol ID
- 0000-0002-9836-9580
- Status last verified
- Apr 2020
- First submitted
- 1 Apr 2020
- Last updated
- 7 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: after aprovel, recommendation of study will be shared with other researchers
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.
PubMed 25590215Kim 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.
PubMed 29750323
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Routine Dissection of Central Lymph Node Necessary for Papillary Thyroid Carcinoma, T1-2 N0?
- ClinicalTrials.gov ID
- NCT04336696
- Acronym / sponsor ID
- 0000-0002-9836-9580
- Conditions
- Papillary Thyroid Carcinoma
- Keywords
- papillary carcinoma, recurrence of PTC, Radio-iodine therapy for PTC
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 199 participants (estimated)
- Lead sponsor
- Bassem Mohamed SiedaOther government
- Study start
- 2 Nov 2016 (actual)
- Primary completion
- 3 Apr 2020 (estimated)
- Study completion
- 3 May 2020 (estimated)
- First posted
- 7 Apr 2020 (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.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- prospective cohort study
| Arm | Type | Receives |
|---|---|---|
| Comparison between the studied groups regarding management. | Active comparator | Procedure: Total thyroidectomy and central neck dissectionThe 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. |
| Recurrence free survival | Other | Procedure: Total thyroidectomy and central neck dissectionpatients with total thyroidectomy only had shorter recurrence free survival |
Who may qualify
- Ages
- 42 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Age ≥20 years, Histopathology proved PTC, with no lymph nodes detected (N0)
Key exclusion criteria (1 listed)
- 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
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 |
|---|---|---|
| Total thyroidectomy and central neck dissection | Procedure or surgery | Comparison between the studied groups regarding management., Recurrence free survival |
Primary outcome
recurrence free survival
Time frame: 21 months
recurrence free survival calculated from first day of diagnosis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2020.
- Results publication: PubMed 25590215Viola 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.
- Results publication: PubMed 29750323Kim 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.
- Individual participant dataSharing planned: Yes. after aprovel, recommendation of study will be shared with other researchers
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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.
Bassem M Sieda contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total thyroidectomy and central neck dissection in people with Papillary Thyroid Carcinoma, run by Bassem Mohamed Sieda at 1 site in Egypt.
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: status not confirmed, as of the sponsor's last update on 7 Apr 2020. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bassem M Sieda (drbassemmostafa@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrence free survival (time frame: 21 months). 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 NCT04336696, which also lists 2 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 7 Apr 2020.