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Impact of BRAFV600E Intratumor Heterogeneity on the Efficacy of Tyrosine Kinase Inhibitors in the Treatment of Radioiodine-resistant Thyroid Cancer


N/A
N/A
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Open (Enrolling)
Both
Differentiated Thyroid Cancer

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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

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