To hear about similar clinical trials, please enter your email below
Trial Title:
Impact of BRAFV600E Intratumor Heterogeneity in Thyroid Cancer Treated With Tyrosine Kinase Inhibitors
NCT ID:
NCT01700699
Condition:
Differentiated Thyroid Cancer
Conditions: Official terms:
Thyroid Neoplasms
Thyroid Diseases
Conditions: Keywords:
thyroid cancer
tyrosine kinase inhibitors
BRAF
Sorafenib
Pazopanib
Sunitinib
Cabozantinib
Study type:
Observational
Overall status:
Unknown status
Study design:
Time perspective:
Retrospective
Summary:
- Background: BRAFV600E is the most frequent oncogene in differentiated thyroid cancer
(DTC) occurring in about 50% of cases. Clinical trials with tyrosine kinase
inhibitors (TKI) with specific activity against BRAF in metastatic
radioiodine-resistant DTC (MRR-DTC) are ongoing. Very recently it has been
demonstrated that DTC often consists of a mixture of tumor cells with wild-type and
mutant BRAF. The subclonal occurrence of BRAFV600E in MRR-DTC could disable the
therapy with BRAF targeted TKI and be responsible of the frequent defeats of this
treatment. A therapeutic strategy based upon BRAF inhibitors in tumors bearing
subclonal BRAFV600E could be initially successful hitting the tumor cells expressing
the oncogene, and after the initial tumor growth arrest and/or shrinkage, the
oncogene negative cells insensitive or less sensitive to the treatment, could
restart the growth of the tumor causing the progression of the disease and the
escape from the clinical response.
- Aims: To determine the impact of subclonal BRAFV600E on the efficacy of BRAF
inhibitors in the treatment of MRR-DTC.
- Study design: Primary tumor tissues will be analyzed for the presence of BRAFV600E
by pyrosequencing or other quantitative assay. If available, synchronous metastases
and post-therapy metachronous metastases will be analyzed as well. The clinical
response will be determined according to RECIST, and the association with the
percentage of BRAFV600E alleles will be evaluated. Attention will be paid to the
possible difference of BRAFwild-type/BRAFV600E ratio between primary tumors and
synchronous metastases, primary tumors and post-therapy metachronous metastases, and
between responsive and resistant synchronous tumor lesions.
Criteria for eligibility:
Study pop:
primary care clinic
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Medicine and Surgery, Univeristy of Salerno
Address:
City:
Baronissi
Zip:
84081
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Mario Vitale, MD
Phone:
+39 089672539
Email:
mavitale@unisa.it
Investigator:
Last name:
Mario Vitale, MD
Email:
Principal Investigator
Start date:
October 2012
Completion date:
October 2013
Lead sponsor:
Agency:
University of Salerno
Agency class:
Other
Source:
University of Salerno
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01700699
