Association Between BRAF V600E and Redifferentiation Therapy in Patients With Radioiodine-refractory Papillary Thyroid Cancer
Sponsor study identifier
observational
25
0 countries
N/A
Study Start
January 1, 2008
Actual (reported)Primary Completion
December 31, 2014
Actual (reported)Study Completion
December 31, 2014
Actual (reported)Papillary thyroid cancer (PTC) is the most common neoplasia in the thyroid gland. The combination of surgery, followed by radioiodine therapy (RIT) and thyroid-stimulating hormone (TSH) suppressive therapy is usually a curative option for differentiated thyroid cancer (DTC). Although DTC has a good prognosis generally, it is problematic when dedifferentiation is suspected and radioiodine refractoriness presumed. One possible therapy option for redifferentiation is the pretreatment with retinoids. From 2008 to 2014 there were 13 patients with PTC who were treated with retinoids after thyroidectomy before a further course of radioiodine. A recent study has shown that the efficacy of Selumetinib, another option for redifferentiation depends on the mutational status of the treated patient. In this retrospective study the investigators looked for a similar association between BRAF V600E and redifferentiation therapy with retinoids. As retinoids have fewer side effects compared to TKI, it is worth performing studies to assess the importance of genetic marker for the response and to estimate the chances of this specific patient collective. BRAF V600E seems to be associated with better long-term response after redifferentiation therapy with 13-cis RA in RAI-R PTC. Therefore, evaluation of BRAF mutational status prior to redifferentiation therapy could be beneficial for predicting response.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2014
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2008
Actual (reported)December 31, 2014
Actual (reported)December 31, 2014
Actual (reported)November 20, 2017
Actual (reported)December 6, 2017
Actual (reported)Response to radioiodine therapy after redifferentiation
Redifferentiation therapy was performed using 13-cis RA (Isotretinoin, Roaccutan®) with a daily dose of orally 1,5mg/kg for up to two months. For assessment of clinical outcome of 13-cis retinoic acid treatment three parameters, tumor size, thyroglobulin levels and radioiodine uptake were considered in a graduated model.
7 years
Parameter tumor size
7 years
Parameter thyroglobulin levels (serum Tg)
7 years
Parameter radioiodine-uptake (RI-Uptake)
7 years
Patients with radioiodine refractory papillary thyroid cancer who received redifferentiation therapy with retinoid acid.
Patients who were in remission after one or two radioiodine therapies.
In this retrospective study, patients with radioiodine refractory papillary thyroid cancer routinely received (clinical indication, no study medication was given) retinoid acid for redifferentiation prior to further course of radioiodine therapy.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Twelve patients with radioiodine-refractory papillary thyroid cancer were treated with retinoic acid before a further course of radioiodine therapy. One patient had to be excluded from the analysis due to missing data in this retrospective analysis. Furthermore, they were compared with twelve patients with radioiodine-sensitive thyroid cancer who were considered as cured after a maximum of two radioiodine therapies.
Stefan Kopf, MD
Head of the Clinical Study Center for Diabetes Research
25 participants (actual enrollment reported by the registry).
First Submitted
November 20, 2017
First Posted
December 6, 2017
Study Start
January 1, 2008
Actual (reported)Evaluating the Safety and Efficacy of Oral Lenvatinib in Medullary and Iodine-131 Refractory, Unresectable Differentiated Thyroid Cancers, Stratified by Histology
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Primary Completion
December 31, 2014
Actual (reported)Study Completion
December 31, 2014
Actual (reported)Last Updated
December 6, 2017
Record last verified: 2017-11
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Source: ClinicalTrials.gov.
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