Papillary Thyroid CancerpCNDNCT04076514
The Role of Central Neck Dissection in Stage N0 Papillary Thyroid Carcinoma
An observational study of Papillary Thyroid Cancer, run by Assiut University at 1 site in Egypt.
Trial summary
The benefits of prophylactic central neck dissection (pCND) remain controversial in clinically node-negative (cN0) papillary thyroid carcinoma (PTC). This study main goal is to investigate benefits of prophylactic central neck dissection in clinically node-negative papillary thyroid carcinoma. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Papillary Thyroid Cancer
- What is being tested?
- central neck dissection
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2020to 1 Nov 2020
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: patients with papillary thyroid carcinoma with clinically negative lymph node who undergo total thyroidectomy and central neck dissetion in assiut university hospital, department of general surgery.
Who may be able to join
- patients with papillary thyroid cancer with clinically node negative.
Who cannot join
- patients with clinical evidence of nodal metastases.
- patients with a previous history of thyroidectomy.
- patients with mixed-type papillary thyroid cancer.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ahmed Kamel
Asyut, Asyut Governorate
ahmed kamel ali, 00201021259455
About this study
The benefits of prophylactic central neck dissection (pCND) remain controversial in clinically node-negative (cN0) papillary thyroid carcinoma (PTC). This study main goal is to investigate benefits of prophylactic central neck dissection in clinically node-negative papillary thyroid carcinoma.
Read the detailed description
Papillary thyroid carcinoma (PTC) is the most common type of differentiated thyroid carcinoma. Recurrence rate is still high. The standard management is total thyroidectomy. regional lymph node metastasis is noted in recurrent cases. Some studies stated benefits of central neck dissection in orevention of recurrence and others said there is no benefits. so prophylactic central neck dissection (pCND) remain controversial in clinically node-negative (cN0) papillary thyroid carcinoma (PTC).
- Conditions
- Papillary Thyroid Cancer
- Being tested
- central neck dissection
- Medical subject headings
- Thyroid Cancer, Papillary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
central neck dissectionProcedure or surgery
dissection of central cervical lymph node grope in low grade papillary thyroid cancer
| Study group | Role | What they receive |
|---|---|---|
| patients with node negative papillary thyroid carcinoma | Not described Receives: Procedure: central neck dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence metastatic lymph node in patients with clinically node-negative thyroid carcinoma who underwent total thyroidectomy with central neck dissection
numbers of positive histopathological lymph node biopsies postoperative
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2019
- Study start1 Sep 2020 (estimated)
- Primary completion30 Sep 2020 (estimated)
- Study completion1 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Papillary Thyroid CancerStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Kamel Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04076514
- Sponsor's protocol ID
- Ahmed1712
- Acronym
- pCND
- Status last verified
- Jul 2020
- First submitted
- 28 Aug 2019
- Last updated
- 14 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Central Neck Dissection in Stage N0 Papillary Thyroid Carcinoma
- ClinicalTrials.gov ID
- NCT04076514
- Acronym / sponsor ID
- pCND / Ahmed1712
- Conditions
- Papillary Thyroid Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 1 Nov 2020 (estimated)
- First posted
- 3 Sep 2019 (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.
The benefits of prophylactic central neck dissection (pCND) remain controversial in clinically node-negative (cN0) papillary thyroid carcinoma (PTC). This study main goal is to investigate benefits of prophylactic central neck dissection in clinically node-negative papillary thyroid carcinoma.
Detailed description
Papillary thyroid carcinoma (PTC) is the most common type of differentiated thyroid carcinoma. Recurrence rate is still high. The standard management is total thyroidectomy. regional lymph node metastasis is noted in recurrent cases. Some studies stated benefits of central neck dissection in orevention of recurrence and others said there is no benefits. so prophylactic central neck dissection (pCND) remain controversial in clinically node-negative (cN0) papillary thyroid carcinoma (PTC).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with node negative papillary thyroid carcinoma | – | Procedure: central neck dissection |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with papillary thyroid carcinoma with clinically negative lymph node who undergo total thyroidectomy and central neck dissetion in assiut university hospital, department of general surgery.
Key inclusion criteria (1 listed)
- patients with papillary thyroid cancer with clinically node negative.
Key exclusion criteria (3 listed)
- patients with clinical evidence of nodal metastases.
- patients with a previous history of thyroidectomy.
- patients with mixed-type papillary thyroid cancer.
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 |
|---|---|---|
| central neck dissectiondissection of central cervical lymph node grope in low grade papillary thyroid cancer | Procedure or surgery | patients with node negative papillary thyroid carcinoma |
Primary outcome
the incidence metastatic lymph node in patients with clinically node-negative thyroid carcinoma who underwent total thyroidectomy with central neck dissection
Time frame: 12 months
numbers of positive histopathological lymph node biopsies postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Papillary Thyroid Cancer, run by Assiut University 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 3 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 14 Jul 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 ahmed kamel ali (00201021259455, ahmed01155@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence metastatic lymph node in patients with clinically node-negative thyroid carcinoma who underwent total thyroidectomy with central neck dissection (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jul 2020.