Thyroid CancerPhase 3NCT00794053
The Usefulness of Staining Lymph Nodes During Operations for Cancer Thyroid in Detecting the Nodes That Have Cancer
A Phase 3 study testing detecting lymph node metastasis by staining in people with Thyroid Cancer and Lymph Node Metastasis, run by University of Alexandria at 1 site in Egypt.
Trial summary
Detection of lymph nodes starting to be involved by cancer spreading from the thyroid gland during operation is useful. It saves the patient from having a second operation to remove these nodes later on when they become obvious. The problem is that there are many lymph nodes around the gland. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thyroid Cancer, Lymph Node Metastasis
- What is being tested?
- detecting lymph node metastasis by staining
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- Dec 2002to Apr 2009
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient diagnosed to have differentiated thyroid carcinoma and has no detectable cervical lymphadenopathy.
Who cannot join
- Previous neck surgery, pregnancy and known hypersensitivity to the dye used.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Alexandria University Hospitals
Alexandria, Alexandria Governorate, 110226
About this study
Official title: The Role of Sentinel Lymph Node Biopsy (SLNB) In the Management of Differentiated Thyroid Cancer
Detection of lymph nodes starting to be involved by cancer spreading from the thyroid gland during operation is useful. It saves the patient from having a second operation to remove these nodes later on when they become obvious. The problem is that there are many lymph nodes around the gland. The theory is that only one node will get the first spill of the tumour cells.
In this study the investigators are trying to use an inert colored material to inject into the tumour. This should run in the same path as the tumour cells and should therefore stain the one lymph node that will be affected first should the tumour spread.
The stained lymph node is excised and examined instantaneously for tumour affection. If it is found to be affected by the tumour, then the operation is extended to include removal of all its fellow lymph nodes. If it is found to be free from the tumour, then this patient does not have tumour spread.
Read the detailed description
The study includes 45 consecutive patients diagnosed as differentiated thyroid cancer by clinical examination and/or fine needle aspiration cytology (FNAC).
Exclusion criteria are: previous neck surgery, pregnancy and known hypersensitivity to the dye used.
An informed consent was obtained from all the patients. Peroperative workup includes history taking, clinical examination, relevant laboratory investigations including thyroid hormone assay, ultrasonography of the neck with special emphasis on the thyroid focal lesion and cervical lymph nodes. FNAC was attempted in all patients.
All patients were then subjected to operation:
A systematized surgical approach was adopted for the purpose of the study: this started by collar incision, development of sub-platysmal skin flaps and separation of strap muscles in the midline. This was followed by exposure of the thyroid gland; identification of the thyroid tumour; injection of the dye into the tumour; waiting for the dye to reach the lymph nodes; identifying the stained node; labeling it as the sentinel node (SLN); performing total thyroidectomy and bilateral central neck dissection.
The resected specimen was fixed by formaldehyde, stained with hematoxylin and eosin and examined with light microscopy.
If the SLN was found to be free of malignant deposits, it was further examined by immunohistochemical staining.
Statistical analysis: Descriptive statistics were used to analyze demographic data. Sensitivity, specificity and predictive value of the SLN were calculated.
The histopathological report of the excised specimen was considered the criterion standard.
- Conditions
- Thyroid Cancer, Lymph Node Metastasis
- Being tested
- detecting lymph node metastasis by staining
- Keywords
- Sentinel lymph node, thyroid cancer, neck dissection
- Medical subject headings
- Thyroid Neoplasms, Lymphatic Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
detecting lymph node metastasis by stainingProcedure or surgery
Also called sentinel lymph node detection, staging of thyroid cancer
this started by collar incision, development of sub-platysmal skin flaps and separation of strap muscles in the midline. This was followed by exposure of the thyroid gland; identification of the thyroid tumour; injection of the dye into the tumour; waiting for the dye to reach the lymph nodes; identifying the stained node; labeling it as the sentinel node (SLN); performing total thyroidectomy and bilateral central neck dissection.
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | The members in this group will undergo intervention by having surgery and lymph node detection by dye staining Receives: Procedure: detecting lymph node metastasis by staining |
What is being measured
The primary outcome is the main question the study is designed to answer.
The lymph nodes around the thyroid tumour will be removed and examined under microscopy in all study subjects to verify that the stained node is a true representative to the state of lymph nodes as regards tumour spread
Measured: the lymph nodes removed during the surgery will be examined the next day of the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2008 (estimated)
- Study startDec 2002
- Primary completionDec 2008
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CancerStudies 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 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alexandria
- Sponsor type
- University, hospital or other
- Investigators
- Yasser M Hamza, A Professor, Principal investigator, University of Alexandria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00794053
- Sponsor's protocol ID
- UAlexandria
- Status last verified
- Jul 2009
- First submitted
- 18 Nov 2008
- Last updated
- 15 Jul 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Sentinel Lymph Node Biopsy (SLNB) In the Management of Differentiated Thyroid Cancer
- ClinicalTrials.gov ID
- NCT00794053
- Acronym / sponsor ID
- UAlexandria
- Conditions
- Thyroid Cancer, Lymph Node Metastasis
- Keywords
- Sentinel lymph node, thyroid cancer, neck dissection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of AlexandriaUniversity, hospital or other
- Study start
- Dec 2002
- Primary completion
- Dec 2008 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 19 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.
Detection of lymph nodes starting to be involved by cancer spreading from the thyroid gland during operation is useful. It saves the patient from having a second operation to remove these nodes later on when they become obvious. The problem is that there are many lymph nodes around the gland. The theory is that only one node will get the first spill of the tumour cells.
In this study the investigators are trying to use an inert colored material to inject into the tumour. This should run in the same path as the tumour cells and should therefore stain the one lymph node that will be affected first should the tumour spread.
The stained lymph node is excised and examined instantaneously for tumour affection. If it is found to be affected by the tumour, then the operation is extended to include removal of all its fellow lymph nodes. If it is found to be free from the tumour, then this patient does not have tumour spread.
Detailed description
The study includes 45 consecutive patients diagnosed as differentiated thyroid cancer by clinical examination and/or fine needle aspiration cytology (FNAC).
Exclusion criteria are: previous neck surgery, pregnancy and known hypersensitivity to the dye used.
An informed consent was obtained from all the patients. Peroperative workup includes history taking, clinical examination, relevant laboratory investigations including thyroid hormone assay, ultrasonography of the neck with special emphasis on the thyroid focal lesion and cervical lymph nodes. FNAC was attempted in all patients.
All patients were then subjected to operation:
A systematized surgical approach was adopted for the purpose of the study: this started by collar incision, development of sub-platysmal skin flaps and separation of strap muscles in the midline. This was followed by exposure of the thyroid gland; identification of the thyroid tumour; injection of the dye into the tumour; waiting for the dye to reach the lymph nodes; identifying the stained node; labeling it as the sentinel node (SLN); performing total thyroidectomy and bilateral central neck dissection.
The resected specimen was fixed by formaldehyde, stained with hematoxylin and eosin and examined with light microscopy.
If the SLN was found to be free of malignant deposits, it was further examined by immunohistochemical staining.
Statistical analysis: Descriptive statistics were used to analyze demographic data. Sensitivity, specificity and predictive value of the SLN were calculated.
The histopathological report of the excised specimen was considered the criterion standard.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Procedure: detecting lymph node metastasis by stainingThe members in this group will undergo intervention by having surgery and lymph node detection by dye staining |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patient diagnosed to have differentiated thyroid carcinoma and has no detectable cervical lymphadenopathy.
Key exclusion criteria (1 listed)
- Previous neck surgery, pregnancy and known hypersensitivity to the dye used.
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 |
|---|---|---|
| detecting lymph node metastasis by stainingAlso: sentinel lymph node detection, staging of thyroid cancerthis started by collar incision, development of sub-platysmal skin flaps and separation of strap muscles in the midline. This was followed by exposure of the thyroid gland; identification of the thyroid tumour; injection of the dye into the tumour; waiting for the dye to reach the lymph nodes; identifying the stained node; labeling it as the sentinel node (SLN); performing total thyroidectomy and bilateral central neck dissection. | Procedure or surgery | study group |
Primary outcome
The lymph nodes around the thyroid tumour will be removed and examined under microscopy in all study subjects to verify that the stained node is a true representative to the state of lymph nodes as regards tumour spread
Time frame: the lymph nodes removed during the surgery will be examined the next day of the operation
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 Jul 2009.
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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.
Yasser M Hamza, A Professor principal investigator
University of Alexandria
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 detecting lymph node metastasis by staining in people with Thyroid Cancer and Lymph Node Metastasis, run by University of Alexandria 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: finished, as of the sponsor's last update on 15 Jul 2009. 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.
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?
The lymph nodes around the thyroid tumour will be removed and examined under microscopy in all study subjects to verify that the stained node is a true representative to the state of lymph nodes as regards tumour spread (time frame: the lymph nodes removed during the surgery will be examined the next day of the operation). 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 15 Jul 2009.