Trial Information
Impact of BRAFV600E Intratumor Heterogeneity on the Efficacy of Tyrosine Kinase Inhibitors in the Treatment of Radioiodine-resistant Thyroid Cancer
Inclusion Criteria:
- subjects any sex any age with metastatic or unresectable thyroid carcinoma treated
with tyrosine kinase inhibitors
- evidence of measurable disease by Response Evaluation Criteria in Solid Tumors
(RECIST)
- availability of study end points including best response, duration of response, and
time to disease progression (based on RECIST), clinical progression, or death
- availability of tumor tissue samples, frozen or formaldehyde fixed-paraffin embedded
from block, genomic DNA already extracted from tumor tissue
Exclusion Criteria:
- concurrent Hashimoto's thyroiditis
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Retrospective
Outcome Measure:
Percentage of BRAFV600E alleles in tumor tissue before TKI treatment
Outcome Time Frame:
within 1 month after the patient has entered the study
Safety Issue:
No
Principal Investigator
Mario Vitale, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Univeristy of Salerno, Italy
Authority:
Italy: Ethics Committee
Study ID:
BRAF-TKI-DTC1
NCT ID:
NCT01700699
Start Date:
October 2012
Completion Date:
October 2013
Related Keywords:
- Differentiated Thyroid Cancer
- thyroid cancer
- tyrosine kinase inhibitors
- BRAF
- Sorafenib
- Pazopanib
- Sunitinib
- Cabozantinib
- Thyroid Neoplasms
- Thyroid Diseases