Clinical Validation of a Predictive Model for the Presence of Cervical Lymph Node Metastasis in Papillary Thyroid Cancer
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Cancer, Cancer, Endocrine |
| Therapuetic Areas: | Endocrinology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/5/2017 |
| Start Date: | April 1, 2015 |
| End Date: | May 31, 2017 |
This research study is performed to compare the accuracy of two methods of lymph node
evaluation: research method versus standard method. Standard method is what is usually
performed as standard of care where the radiologist evaluates the images overall and decides
whether each node seen should or should not be biopsied. In the research method, a second
radiologist will evaluate the ultrasound images of the lymph nodes separately, and use a
small specific checklist of ultrasound appearance to determine whether each node should or
should not be biopsied. Results of both the standard and research method will be used to
decide which node(s), if any should be biopsied. Neck ultrasound examination, lymph node
evaluation by standard method and subsequent lymph node biopsy are part of the standard
clinical care. It is less likely but possible that the research method may identify
additional lymph nodes for biopsy to check if that lymph node contains thyroid cancer.
evaluation: research method versus standard method. Standard method is what is usually
performed as standard of care where the radiologist evaluates the images overall and decides
whether each node seen should or should not be biopsied. In the research method, a second
radiologist will evaluate the ultrasound images of the lymph nodes separately, and use a
small specific checklist of ultrasound appearance to determine whether each node should or
should not be biopsied. Results of both the standard and research method will be used to
decide which node(s), if any should be biopsied. Neck ultrasound examination, lymph node
evaluation by standard method and subsequent lymph node biopsy are part of the standard
clinical care. It is less likely but possible that the research method may identify
additional lymph nodes for biopsy to check if that lymph node contains thyroid cancer.
Inclusion Criteria:
- Diagnosis of PTC and at least one sonographic examination of the cervical lymph
nodes.
- Patients can only be included in the study once. Thus, if they have two sonographic
examinations, only one can be included in the study results.
- All patients who fit the study criteria after the start of the study will be
included, using the first sonographic exam as the study exam.
Exclusion Criteria:
- Lymph node with oval shape, hypoechoic cortex, smooth border, hyperechoic hilum and
hilar Doppler flow by ultrasound are considered to be normal and be excluded from
FNAB per standard clinical practice.
- Lymph node less than 5 mm in short axis on ultrasound.
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