Thyroid CancerPhase 3NCT00795782
Prophylactic Central Lymph Node Dissection in Papillary Thyroid Microcarcinoma
A Phase 3 study testing Prophylactic central lymph node dissection in people with Thyroid Cancer, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to determine whether the prophylactic ipsilateral central lymph node dissection is equally effective in the management of papillary thyroid microcarcinoma(PTMC) to the bilateral central lymph node dissection. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Thyroid Cancer
- What is being tested?
- Prophylactic central lymph node dissection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 258 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2009to Jun 2014
- Phase
- Phase 3
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18 to 70
- Sonographically node-negative cytology confirmed thyroid papillary carcinoma
- Tumor size less than 1 cm in sonography
- Tumor confined to the one lobe of the thyroid gland
- One who provides the informed consent
Who cannot join
- History of radiation treatment to head and neck area
- History of other malignancy except thyroid cancer
- Poor performance status (ECOG 3-4)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prophylactic Central Lymph Node Dissection in Papillary Thyroid Microcarcinoma: A Prospective Randomized Controlled Trial
The purpose of this study is to determine whether the prophylactic ipsilateral central lymph node dissection is equally effective in the management of papillary thyroid microcarcinoma(PTMC) to the bilateral central lymph node dissection.
Read the detailed description
The extent, the advantage and disadvantage of prophylactic central lymph node dissection was not fully established up to now in papillary thyroid microcarcinoma.
Prophylactic bilateral central lymph node dissection can give a important clinical information about the status of lymph nodes, and possibly guide a further adjuvant treatment. However, it causes high postoperative morbidity, including hypocalcemia and hoarseness. In this respect, some advocate no central lymph node dissection in prophylactic settings.
Thus, we aimed to prove the efficacy of prophylactic ipsilateral central lymph node dissection in thyroid papillary microcarcinoma, compared to the bilateral dissection and no dissection.
Type of Study design: Prospective randomized, controlled double-blinded (to subjects and observers) study.
Group I: Limited/ipsilateral central lymph node dissection (UniCND) Group II: Comprehensive/bilateral central lymph node dissection (BiCND) Group III: No central lymph node dissection (NoCND)
Outcomes: vocal cord palsy, hypocalcemia, locoregional recurrence, distant metastasis
- Conditions
- Thyroid Cancer
- Being tested
- Prophylactic central lymph node dissection
- Keywords
- Papillary thyroid carcinoma, Lymph node dissection, Lymph node metastasis, Prophylactic node dissection, Central lymph node metastasis
- Medical subject headings
- Thyroid Neoplasms, Thyroid Cancer, Papillary, Lymphatic Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prophylactic central lymph node dissectionProcedure or surgery
prophylactic ipsilateral versus bilateral central lymph node dissection
| Study group | Role | What they receive |
|---|---|---|
| UniCND | Experimental | Limited/ipsilateral central lymph node dissection Receives: Procedure: Prophylactic central lymph node dissection |
| BiCND | Active comparator | Comprehensive/bilateral central lymph node dissection Receives: Procedure: Prophylactic central lymph node dissection |
| NoCND | No intervention | No central lymph node dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence (Thyroglobulin level, antiTG level, results of follow-up imaging tools)
Measured: 3 year after initial treatment
Secondary outcomes (1)
Postoperative complications(hypocalcemia, hoarseness)
Measured: up to 3 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2008 (estimated)
- Study startJan 2009
- Primary completionJun 2012
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 258 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Han-Sin Jeong, MD, PhD, Principal investigator, Samsung Medical Center, Department of Otorhinolaryngology-Head and Neck Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00795782
- Sponsor's protocol ID
- 2008-09-048
- Status last verified
- Jul 2011
- First submitted
- 19 Nov 2008
- Last updated
- 15 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Son YI, Jeong HS, Baek CH, Chung MK, Ryu J, Chung JH, So YK, Jang JY, Choi J. Extent of prophylactic lymph node dissection in the central neck area of the patients with papillary thyroid carcinoma: comparison of limited versus comprehensive lymph node dissection in a 2-year safety study. Ann Surg Oncol. 2008 Jul;15(7):2020-6. doi: 10.1245/s10434-008-9928-8. Epub 2008 May 6.
PubMed 18459004
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Central Lymph Node Dissection in Papillary Thyroid Microcarcinoma: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00795782
- Acronym / sponsor ID
- 2008-09-048
- Conditions
- Thyroid Cancer
- Keywords
- Papillary thyroid carcinoma, Lymph node dissection, Lymph node metastasis, Prophylactic node dissection, Central lymph node metastasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 258 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 21 Nov 2008 (estimated)
- 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 purpose of this study is to determine whether the prophylactic ipsilateral central lymph node dissection is equally effective in the management of papillary thyroid microcarcinoma(PTMC) to the bilateral central lymph node dissection.
Detailed description
The extent, the advantage and disadvantage of prophylactic central lymph node dissection was not fully established up to now in papillary thyroid microcarcinoma.
Prophylactic bilateral central lymph node dissection can give a important clinical information about the status of lymph nodes, and possibly guide a further adjuvant treatment. However, it causes high postoperative morbidity, including hypocalcemia and hoarseness. In this respect, some advocate no central lymph node dissection in prophylactic settings.
Thus, we aimed to prove the efficacy of prophylactic ipsilateral central lymph node dissection in thyroid papillary microcarcinoma, compared to the bilateral dissection and no dissection.
Type of Study design: Prospective randomized, controlled double-blinded (to subjects and observers) study.
Group I: Limited/ipsilateral central lymph node dissection (UniCND) Group II: Comprehensive/bilateral central lymph node dissection (BiCND) Group III: No central lymph node dissection (NoCND)
Outcomes: vocal cord palsy, hypocalcemia, locoregional recurrence, distant metastasis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| UniCND | Experimental | Procedure: Prophylactic central lymph node dissectionLimited/ipsilateral central lymph node dissection |
| BiCND | Active comparator | Procedure: Prophylactic central lymph node dissectionComprehensive/bilateral central lymph node dissection |
| NoCND | No intervention | –No central lymph node dissection |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: 18 to 70
- Sonographically node-negative cytology confirmed thyroid papillary carcinoma
- Tumor size less than 1 cm in sonography
- Tumor confined to the one lobe of the thyroid gland
- One who provides the informed consent
Key exclusion criteria (3 listed)
- History of radiation treatment to head and neck area
- History of other malignancy except thyroid cancer
- Poor performance status (ECOG 3-4)
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 |
|---|---|---|
| Prophylactic central lymph node dissectionprophylactic ipsilateral versus bilateral central lymph node dissection | Procedure or surgery | BiCND, UniCND |
Primary outcome
Recurrence (Thyroglobulin level, antiTG level, results of follow-up imaging tools)
Time frame: 3 year after initial treatment
1 secondary outcome
Postoperative complications(hypocalcemia, hoarseness)
Time frame: up to 3 years after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2016.
- Background: PubMed 18459004Son YI, Jeong HS, Baek CH, Chung MK, Ryu J, Chung JH, So YK, Jang JY, Choi J. Extent of prophylactic lymph node dissection in the central neck area of the patients with papillary thyroid carcinoma: comparison of limited versus comprehensive lymph node dissection in a 2-year safety study. Ann Surg Oncol. 2008 Jul;15(7):2020-6. doi: 10.1245/s10434-008-9928-8. Epub 2008 May 6.
- 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.
Han-Sin Jeong, MD, PhD principal investigator
Samsung Medical Center, Department of Otorhinolaryngology-Head and Neck Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Prophylactic central lymph node dissection in people with Thyroid Cancer, run by Samsung Medical Center at 1 site in South Korea.
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 5 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: finished, as of the sponsor's last update on 15 Apr 2016. 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 South Korea. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence (Thyroglobulin level, antiTG level, results of follow-up imaging tools) (time frame: 3 year after initial treatment). 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 NCT00795782, which also lists 1 linked publication.
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 15 Apr 2016.