An observational study in Thyroid Cancer, sponsored by Heidelberg University. Completed. Open to participants aged 24 Years to 69 Years. Per ClinicalTrials.gov, last updated 2017-12-06.
Sponsored by Heidelberg University · Observational
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.
819 studies on the registry are indexed under Thyroid Neoplasms; 216 are open to participants now.
This study's enrollment of 25 is below the median of 160 across 267 observational studies indexed under Thyroid Neoplasms.
Browse Thyroid Neoplasms studies →Heidelberg University is the lead sponsor of 287 studies on the registry; 19 are open to participants now.
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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.
Eligible criteria for radioiodine-refractory patients included:
Eligible criteria for radioiodine-sensitive patients included:
Exclusion criteria
Patients with radioiodine refractory papillary thyroid cancer who received redifferentiation therapy with retinoid acid.
Drug: Redifferentiation 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.
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.
Time frame: 7 years
Parameter tumor size
Tumor size was evaluated form CT, MRI, or FDG-PET/CT imaging, comparing results before and after redifferentiation and RIT, results were evaluated using Response Evaluation Criteria in Solid Tumors (RECIST).
Time frame: 7 years
Parameter thyroglobulin levels (serum Tg)
Non-stimulated serum Tg level (in ng/ml) before redifferentiation therapy was compared with the first Tg level after redifferentiation and RIT. A stable Tg level was defined as ≤10% difference.
Time frame: 7 years
Parameter radioiodine-uptake (RI-Uptake)
Recovery of RI-Uptake was evaluated from the post-therapy whole body scan in comparison to the lesions in CT, MRI, or FDG-PET/CT imaging before redifferentiation. Optimal uptake was defined as intensive accumulation of radioiodine in all tumor lesions. When not all lesions accumulate radioiodine or the signal was weak it was considered as suboptimal uptake.
Time frame: 7 years
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