CarcinomaPhase 2/3NCT01149161
Extent of Central Lymph Node Dissection in Papillary Thyroid Microcarcinoma
A Phase 2/3 study testing Routine central neck dissection in people with Carcinoma, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Occult lymph node metastasis is common in micro papillary thyroid cancer. However, the role of lymph node dissection in the treatment of microPTC remains controversial. The investigators want to investigate the usefulness routine central dissection and sentinel lymph node biopsy in prognosis of micro PTC. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Carcinoma
- What is being tested?
- Routine central neck dissection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2009to Dec 2020
- Phase
- Phase 2/3
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- papillary carcinoma of thyroid (less than 4cm)
- no evidence of lymph node metastasis in preoperative work-up result
- the patients who accept this study
Who cannot join
- large thyroid cancer( > 4cm)
- morbid
- anticoagulation agent usage
- endoscopic or robotic thyroid operation
- evidence of lymph node metastasis or extrathyroidal extension in preoperative US and CT scan
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, 135-710
Jee Soo Kim, M.D., Ph.D., 82-2-3410-3479
About this study
Official title: Sentinel Lymph Node Biopsy in the Thyroid Carcinoma; Randomized, Prospective Study
Occult lymph node metastasis is common in micro papillary thyroid cancer. However, the role of lymph node dissection in the treatment of microPTC remains controversial. The investigators want to investigate the usefulness routine central dissection and sentinel lymph node biopsy in prognosis of micro PTC. This is a prospective randomized control study. The investigators started this study from May of 2009 and this study will be continued until Dec. 2011.
Read the detailed description
The investigators will assign all patients to three groups; no dissection group (Group I), sentinel lymph node biopsy only group (Group II) and routine central neck dissection group (Group III). At first, to know the necessity of routine central neck node dissection for micro PTC,the investigators will compare the result of group I and group III. Additionally, the investigators can analyze the usefulness of sentinel lymph node biopsy for substitution of routine central neck node dissection for micro PTC.
- Conditions
- Carcinoma
- Being tested
- Routine central neck dissection
- Keywords
- neck dissection, sentinel lymph node, Carcinoma, Papillary, thyroid, dissection
- Medical subject headings
- Carcinoma, Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine central neck dissectionProcedure or surgery
Level VI neck node dissection during thyroid operation
| Study group | Role | What they receive |
|---|---|---|
| C group | Active comparator | Routine central neck dissection Receives: Procedure: Routine central neck dissection |
| N group | No intervention | No central neck node dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Is routine neck node dissection necessary in micro PTC?
To see the necessity of routine neck node dissection in micro PTC, we will compare the recurrence rate and other complication (e.g. hoarseness and hypocalcemia) between group I(no dissection) and group III(routine dissection) after completion of study(after 5 year f/u).
To check the safety of this study, our result will be checked by korea institutional reveiw board every one year.
Measured: Until 5 year follow-up. (Dec. 2016)
Secondary outcomes (1)
The efficacy of sentinel lymph node biopsy in micro PTC
Measured: Until 5 year follow-up. (Dec. 2016)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2010 (estimated)
- Study startMay 2009
- Primary completionDec 2017 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CarcinomaStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jee soo Kim, Samsung Medical Center
- Investigators
- Jee Soo Kim, M.D., Ph.D., Study chair, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01149161
- Sponsor's protocol ID
- 2009-02-017
- Status last verified
- Apr 2016
- First submitted
- 2 Jun 2010
- Last updated
- 21 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sentinel Lymph Node Biopsy in the Thyroid Carcinoma; Randomized, Prospective Study
- ClinicalTrials.gov ID
- NCT01149161
- Acronym / sponsor ID
- 2009-02-017
- Conditions
- Carcinoma
- Keywords
- neck dissection, sentinel lymph node, Carcinoma, Papillary, thyroid, dissection
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 23 Jun 2010 (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.
Occult lymph node metastasis is common in micro papillary thyroid cancer. However, the role of lymph node dissection in the treatment of microPTC remains controversial. The investigators want to investigate the usefulness routine central dissection and sentinel lymph node biopsy in prognosis of micro PTC. This is a prospective randomized control study. The investigators started this study from May of 2009 and this study will be continued until Dec. 2011.
Detailed description
The investigators will assign all patients to three groups; no dissection group (Group I), sentinel lymph node biopsy only group (Group II) and routine central neck dissection group (Group III). At first, to know the necessity of routine central neck node dissection for micro PTC,the investigators will compare the result of group I and group III. Additionally, the investigators can analyze the usefulness of sentinel lymph node biopsy for substitution of routine central neck node dissection for micro PTC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| C group | Active comparator | Procedure: Routine central neck dissectionRoutine central neck dissection |
| N group | No intervention | –No central neck node dissection |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- papillary carcinoma of thyroid (less than 4cm)
- no evidence of lymph node metastasis in preoperative work-up result
- the patients who accept this study
Key exclusion criteria (5 listed)
- large thyroid cancer( > 4cm)
- morbid
- anticoagulation agent usage
- endoscopic or robotic thyroid operation
- evidence of lymph node metastasis or extrathyroidal extension in preoperative US and CT scan
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 |
|---|---|---|
| Routine central neck dissectionLevel VI neck node dissection during thyroid operation | Procedure or surgery | C group |
Primary outcome
Is routine neck node dissection necessary in micro PTC?
Time frame: Until 5 year follow-up. (Dec. 2016)
To see the necessity of routine neck node dissection in micro PTC, we will compare the recurrence rate and other complication (e.g. hoarseness and hypocalcemia) between group I(no dissection) and group III(routine dissection) after completion of study(after 5 year f/u). To check the safety of this study, our result will be checked by korea institutional reveiw board every one year.
1 secondary outcome
The efficacy of sentinel lymph node biopsy in micro PTC
Time frame: Until 5 year follow-up. (Dec. 2016)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2016.
- Individual participant dataSharing planned: No
Related trials for Carcinoma
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 1
Study of Preoperative Radiation Therapy in Participants With Resectable Recurrent Abdominal Adrenocortical Carcinoma
Adrenocortical Carcinoma (ACC), Recurrent Adrenocortical Carcinoma (ACC)
Active, not recruitingPhase 2
Treating Muscle-invasive Bladder Cancer With A Non-surgical Method Consisting of Anti-PD-1 Therapy and Chemoradiation
Muscle-Invasive Bladder Carcinoma, Programmed Cell Death Protein 1 Inhibitor
RecruitingPhase 2/3
Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7
Advanced Non-Small Cell Lung Cancer, Metastatic Non-Small Cell Lung Cancer
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.
Jee Soo Kim, M.D., Ph.D. study chair
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Routine central neck dissection in people with Carcinoma, 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 3 inclusion and 5 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 21 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jee Soo Kim, M.D., Ph.D. (82-2-3410-3479, js0507.kim@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Is routine neck node dissection necessary in micro PTC? (time frame: Until 5 year follow-up. (Dec. 2016)). 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 21 Apr 2016.