- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02561533
Detection of BRAF Mutation on FNAB From Papillary Thyroid Carcinoma
Immunohistochemical Detection of the BRAFV600E Mutation on Cytological Specimen in PTC
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The BRAF mutation is reported to be present in approximately 50% of papillary thyroid carcinomas (PTC). The mutation has been associated with poor prognosis and more advanced disease stage. Therefore, pre-operative detection of the BRAF-V600E mutation may be of clinical interest in order to individualize treatment of patients with BRAF positive PTC.
FNABs are performed immediately before the thyroid operation, and BRAF-V600E detection using VE1 is performed on clots. The VE1 stain is compared to the mutation status of the removed cancer or control tissue using the Cobas test.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Aarhus C, Denmark, 8000
- Aarhus University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Bethesda system of reporting thyroid cytology (BSRTC) group 5-6 on pre-operative FNAB from the nodule (>1cm)
- Undergoing thyroid surgery (histology of index nodule)
Exclusion Criteria:
- Not undergoing thyroid surgery
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BRAF immunohistochemistry (IHC)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immunohistochemical detection of BRAF mutation on fine needle aspiration biopsy (FNAB)
Time Frame: 1 day
|
Mutations status correlated to histological diagnoses and mutation status on histological samples
|
1 day
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TIHCDBMTC1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Papillary Thyroid Carcinoma
-
National Cancer Institute (NCI)ExelixisCompletedRecurrent Thyroid Gland Carcinoma | Poorly Differentiated Thyroid Gland Carcinoma | Stage I Thyroid Gland Papillary Carcinoma | Stage II Thyroid Gland Papillary Carcinoma | Stage III Thyroid Gland Papillary Carcinoma | Tall Cell Variant Thyroid Gland Papillary Carcinoma | Stage I Thyroid Gland... and other conditionsUnited States
-
National Cancer Institute (NCI)CompletedRecurrent Thyroid Gland Carcinoma | Stage I Thyroid Gland Papillary Carcinoma | Stage II Thyroid Gland Papillary Carcinoma | Stage III Thyroid Gland Papillary Carcinoma | Stage IV Thyroid Gland Papillary CarcinomaUnited States, Canada
-
Grupo Espanol de Tumores NeuroendocrinosMFARActive, not recruitingMetastatic Thyroid Cancer | Metastatic Thyroid Papillary Carcinoma | Metastatic Thyroid Follicular CarcinomaSpain
-
National Cancer Institute (NCI)Active, not recruitingPoorly Differentiated Thyroid Gland Carcinoma | Refractory Differentiated Thyroid Gland Carcinoma | Refractory Thyroid Gland Carcinoma | Follicular Variant Thyroid Gland Papillary Carcinoma | Tall Cell Variant Thyroid Gland Papillary Carcinoma | Differentiated Thyroid Gland Carcinoma | Thyroid... and other conditionsUnited States
-
National Cancer Institute (NCI)CompletedRecurrent Thyroid Gland Carcinoma | Stage III Thyroid Gland Papillary Carcinoma | Stage IV Thyroid Gland Papillary Carcinoma | Stage III Thyroid Gland Follicular Carcinoma | Stage IV Thyroid Gland Follicular CarcinomaUnited States
-
National Cancer Institute (NCI)CompletedRefractory Differentiated Thyroid Gland Carcinoma | Unresectable Thyroid Gland Carcinoma | Refractory Thyroid Gland Papillary Carcinoma | Refractory Thyroid Gland Follicular Carcinoma | Refractory Thyroid Gland Hurthle Cell CarcinomaUnited States, Canada
-
Academic and Community Cancer Research UnitedNational Cancer Institute (NCI)CompletedPoorly Differentiated Thyroid Gland Carcinoma | Recurrent Differentiated Thyroid Gland Carcinoma | Columnar Cell Variant Thyroid Gland Papillary Carcinoma | Follicular Variant Thyroid Gland Papillary Carcinoma | Metastatic Thyroid Gland Follicular Carcinoma | Metastatic Thyroid Gland Papillary... and other conditionsUnited States
-
Mayo ClinicNational Cancer Institute (NCI)RecruitingDifferentiated Thyroid Gland Carcinoma | Thyroid Gland Follicular Carcinoma | Thyroid Gland Papillary CarcinomaUnited States
-
The First Affiliated Hospital of Xiamen UniversityRecruitingRefractory Thyroid Gland Carcinoma | Refractory Thyroid Gland Papillary Carcinoma | Refractory Thyroid Gland Follicular Carcinoma | Refractory Thyroid Gland Hurthle Cell CarcinomaChina
-
Academic and Community Cancer Research UnitedNational Cancer Institute (NCI)Active, not recruitingRecurrent Thyroid Gland Carcinoma | Poorly Differentiated Thyroid Gland Carcinoma | Stage IV Thyroid Gland Follicular Carcinoma AJCC v7 | Stage IV Thyroid Gland Papillary Carcinoma AJCC v7 | Stage IVA Thyroid Gland Follicular Carcinoma AJCC v7 | Stage IVA Thyroid Gland Papillary Carcinoma AJCC... and other conditionsUnited States
Clinical Trials on BRAF detection on fine needle aspiration biopsy (FNAB)
-
Assistance Publique - Hôpitaux de ParisNot yet recruitingThermal Ablation | Thyroid Nodules | Fine Needle Aspiration Biopsy
-
Washington University School of MedicineSociety for Surgical Oncologists; Sysmex America, Inc.CompletedBreast NeoplasmsUnited States
-
Washington University School of MedicineWithdrawnUveal Neoplasms | Choroid Neoplasms | Iris NeoplasmsUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingMalignant NeoplasmUnited States
-
AdventHealthUnknown
-
Kocaeli UniversityRecruiting
-
Sidney Kimmel Comprehensive Cancer Center at Johns...Terminated
-
Mayo ClinicMedtronicCompletedPancreatic CancerUnited States
-
Northwestern UniversityCompletedPancreatic Cancer | Lymphadenopathy | Gastrointestinal Stromal TumorUnited States