Thyroid CancerNCT03363347
BRAF V600E and Redifferentiation Therapy in Radioiodine-refractory Papillary Thyroid Cancer
An observational study of Thyroid Cancer, run by Heidelberg University.
Trial 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). Read more about this study
- Who is it for?
- Ages 24 to 69 years
- Conditions the study is for
- Thyroid Cancer
- What is being tested?
- Redifferentiation with retinoid acid
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2008to 31 Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
None listed.
Who cannot join
- 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.
About this study
Official title: Association Between BRAF V600E and Redifferentiation Therapy in Patients With Radioiodine-refractory Papillary Thyroid Cancer
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
- Being tested
- Redifferentiation with retinoid acid
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Redifferentiation with retinoid acidDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Radioiodine refractory papillary thyroid cancer | Patients with radioiodine refractory papillary thyroid cancer who received redifferentiation therapy with retinoid acid. Receives: Drug: Redifferentiation with retinoid acid | |
| Radioiodine sensitive papillary thyroid cancer | Patients who were in remission after one or two radioiodine therapies. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 years
Secondary outcomes (3)
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).
Measured: 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.
Measured: 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.
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2017
- Study start1 Jan 2008
- Primary completion31 Dec 2014
- Study completion31 Dec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefan Kopf MD, Heidelberg University
- Investigators
- Stefan Kopf, MD, Principal investigator, Head of the Clinical Study Center for Diabetes Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03363347
- Sponsor's protocol ID
- S-206/2005
- Status last verified
- Nov 2017
- First submitted
- 20 Nov 2017
- Last updated
- 6 Dec 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between BRAF V600E and Redifferentiation Therapy in Patients With Radioiodine-refractory Papillary Thyroid Cancer
- ClinicalTrials.gov ID
- NCT03363347
- Acronym / sponsor ID
- S-206/2005
- Conditions
- Thyroid Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- 1 Jan 2008 (actual)
- Primary completion
- 31 Dec 2014 (actual)
- Study completion
- 31 Dec 2014 (actual)
- First posted
- 6 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radioiodine refractory papillary thyroid cancer | – | Drug: Redifferentiation with retinoid acidPatients with radioiodine refractory papillary thyroid cancer who received redifferentiation therapy with retinoid acid. |
| Radioiodine sensitive papillary thyroid cancer | – | –Patients who were in remission after one or two radioiodine therapies. |
Who may qualify
- Ages
- 24 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Redifferentiation with retinoid acidIn 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. | Drug | Radioiodine refractory papillary thyroid cancer |
Primary outcome
Response to radioiodine therapy after redifferentiation
Time frame: 7 years
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.
3 secondary outcomes
Parameter tumor size
Time frame: 7 years
Parameter thyroglobulin levels (serum Tg)
Time frame: 7 years
Parameter radioiodine-uptake (RI-Uptake)
Time frame: 7 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Kopf, MD principal investigator
Head of the Clinical Study Center for Diabetes Research
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Cancer, run by Heidelberg University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response to radioiodine therapy after redifferentiation (time frame: 7 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2017.