BRAF V600E and Redifferentiation Therapy in Radioiodine-refractory Papillary Thyroid Cancer

NCT03363347 | Completed

• 1 other identifier: S-206/2005
• Study Type: observational
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Thyroid Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Parameter tumor size

  7 years

• Parameter thyroglobulin levels (serum Tg)

  7 years

• Parameter radioiodine-uptake (RI-Uptake)

  7 years

Study Arms (2)

Radioiodine refractory papillary thyroid cancer

Patients with radioiodine refractory papillary thyroid cancer who received redifferentiation therapy with retinoid acid.

Drug: Redifferentiation with retinoid acid

Radioiodine sensitive papillary thyroid cancer

Patients who were in remission after one or two radioiodine therapies.

Interventions

Redifferentiation with retinoid acid DRUG

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.

Radioiodine refractory papillary thyroid cancer

Eligibility Criteria

• Age: 24 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may not qualify if:

• DTC other than PTC
• patients lost to follow-up
• other redifferentiation therapy than retinoids
• anaplastic or medullary thyroid cancer
• benign thyroid disease, no available FFPE tissue
• more than two RITs in the control group
• insufficient clinical information.

Sponsors & Collaborators

• Heidelberg University: lead

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Study Officials

• Stefan Kopf, MD

  Head of the Clinical Study Center for Diabetes Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Clinical Study Center for Diabetes Research

Study Record Dates

• First Submitted: November 20, 2017
• First Posted: December 6, 2017
• Study Start: January 1, 2008
• Primary Completion: December 31, 2014
• Study Completion: December 31, 2014
• Last Updated: December 6, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share