Thyroid CancerNCT01736163
A Retrospective Observational Study Comparing Two Different Treatment Options in Thyroid Cancer Patients With T4 Tumours
An observational study of Thyroid Cancer, run by Genzyme, a Sanofi Company at 9 sites in 4 countries.
Trial summary
The study is to demonstrate non-inferior thyroid remnant first ablation success of Thyrogen and 131I compared to thyroid hormone withdrawal (THW) and 131I in patients with T4 tumour based on historical diagnostic whole body scan (DxWBS) records. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Cancer
- What is being tested?
- Thyrogen, 131I and Thyroid Hormone Withdrawal
- How many people
- 144 participants
- Where
- 9 sitesin 4 countries
- Study dates
- May 2012to Aug 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Historical records at clinical sites will be reviewed in a systematic fashion to identify eligible patients.
Who may be able to join
- Historical records from patients who meet all of the following criteria will be eligible for inclusion in this retrospective evaluation:
- Male or female patients living or deceased, aged 18 years or older at the time of first ablation for thyroid cancer.
- Diagnosed with a well-differentiated T4 tumour (defined as a primary tumour of any size that extends beyond the thyroid capsule [this may be referred to as TNM classification T4, N0-1, M0-1]). This excludes unusual histological types such as oncocytic (Hurthle cell carcinoma), tall cell, sclerosing or cribriform thyroid cancers.
- Undergone a near-total or total thyroidectomy on or after 01 January 2000
- Undergone first ablation of thyroid remnants with high activity 131I (≥28 mCi or ≥ 1.036 GBq).
- Undergone first 131I ablation for the T4 tumour using either Thyrogen (0.9 mg IM on 2 consecutive days) or THW stimulation. This excludes use of non-standard Thyrogen regimens (i.e., had a regimen of Thyrogen other than the standard 0.9 mg IM on 2 consecutive days or received Thyrogen in combination with THW).
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- Historical records are available confirming ablation results by:
- DxWBS using small activity (≥2 mCi or 74 MBq) of iodine 131I (or 123I) performed at least 6 months after administration of the first ablation activity of 131I and/or
- Stimulated Tg measured at least 6 months after administration of the first ablation activity of 131I.
Who cannot join
- Historical records from patients who meet any of the following criteria will be excluded from this retrospective evaluation:
- Received propylthiouracil, methimazole, vitamins or supplements containing kelp or iodine (taking a multivitamin that does not contain iodine or kelp is acceptable), medications that significantly affect iodine handling such as high dose corticosteroids, high dose diuretics, or lithium in the 45 days before administration of first ablative activity of 131I.
- Received any iodine-containing contrast agents within 3 months prior to first ablative activity of 131I administered.
- Used amiodarone within the 2 years prior to first ablative activity of 131I administered.
Trial locations and contacts
9 sites in 4 countries.
9 sites in 4 countries
Italy3 sites
Policlinico S.Orsola-Malpighi
Bologna
Instituto Oncologico Veneto
Padova
Istituti Fisioterapici Ospitalieri (IFO)
Rome
Spain3 sites
Hospital Universitario Reina Sofía
Córdoba
Hospital Universitario Virgen de las Nieves
Granada
Hospital Universitario Dr Peset
Valencia
Germany2 sites
Hanover University School of Medicine
Hanover
Klinikum Großhadern
München
About this study
Official title: A Retrospective, Non-interventional Study of Patients With T4 Tumours Comparing the Thyroid Remnant Ablation Success Following Thyrogen and 131I Administration Versus Thyroid Hormone Withdrawal and 131I Administration
The study is to demonstrate non-inferior thyroid remnant first ablation success of Thyrogen and 131I compared to thyroid hormone withdrawal (THW) and 131I in patients with T4 tumour based on historical diagnostic whole body scan (DxWBS) records.
- Conditions
- Thyroid Cancer
- Being tested
- Thyrogen, 131I, Thyroid Hormone Withdrawal
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThyrogenDrug
0.9 mg IM, administrated for 2 consecutive days
131IDrug
28 mCi or ≥ 1.036 GBq.
Thyroid Hormone WithdrawalOther
Stop taking hormone therapy
| Study group | Role | What they receive |
|---|---|---|
| Thyrogen and 131I | Patients were previously treated with Thyrogen in conjunction with a high ablative activity of 131I. Receives: Drug: Thyrogen; Drug: 131I | |
| Thyroid Hormone Withdrawal and 131I | Patients were previously treated with Thyroid hormone withdrawal (THW) in conjunction with a high ablative activity of 131I. Receives: Drug: 131I; Other: Thyroid Hormone Withdrawal |
What is being measured
The primary outcome is the main question the study is designed to answer.
First ablation success rate by Diagnostic Whole Body Scan (DxWBS)
Measured: at least 6 months after administration of first ablation activity of 131I
Secondary outcomes (3)
First ablation success rate based on stimulated Thyroglobulin (Tg) levels
Measured: at least 6 months after administration of first ablation activity of 131I
First ablation success rate based on historical records
Measured: at least 6 months after administration of first ablation activity of 131I
Number of adverse events of Thyrogen and 131I arm and THW and 131I arm
Exploratory safety assessment in patients with T4 tumour for first ablation of thyroid remnants based on historical records.
Measured: Within 30 days of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2012 (estimated)
- Study startMay 2012
- Primary completionAug 2012
- Study completionAug 2012
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
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genzyme, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Genzyme, a Sanofi Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01736163
- Sponsor's protocol ID
- THYR04910
- Status last verified
- Mar 2015
- First submitted
- 26 Nov 2012
- Last updated
- 23 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective, Non-interventional Study of Patients With T4 Tumours Comparing the Thyroid Remnant Ablation Success Following Thyrogen and 131I Administration Versus Thyroid Hormone Withdrawal and 131I Administration
- ClinicalTrials.gov ID
- NCT01736163
- Acronym / sponsor ID
- THYR04910
- Conditions
- Thyroid Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 29 Nov 2012 (estimated)
- 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.
The study is to demonstrate non-inferior thyroid remnant first ablation success of Thyrogen and 131I compared to thyroid hormone withdrawal (THW) and 131I in patients with T4 tumour based on historical diagnostic whole body scan (DxWBS) records.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thyrogen and 131I | – | Drug: Thyrogen, Drug: 131IPatients were previously treated with Thyrogen in conjunction with a high ablative activity of 131I. |
| Thyroid Hormone Withdrawal and 131I | – | Drug: 131I, Other: Thyroid Hormone WithdrawalPatients were previously treated with Thyroid hormone withdrawal (THW) in conjunction with a high ablative activity of 131I. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Historical records at clinical sites will be reviewed in a systematic fashion to identify eligible patients.
Key inclusion criteria (9 listed)
- Historical records from patients who meet all of the following criteria will be eligible for inclusion in this retrospective evaluation:
- Male or female patients living or deceased, aged 18 years or older at the time of first ablation for thyroid cancer.
- Diagnosed with a well-differentiated T4 tumour (defined as a primary tumour of any size that extends beyond the thyroid capsule [this may be referred to as TNM classification T4, N0-1, M0-1]). This excludes unusual histological types such as oncocytic (Hurthle cell carcinoma), tall cell, sclerosing or cribriform thyroid cancers.
- Undergone a near-total or total thyroidectomy on or after 01 January 2000
- Undergone first ablation of thyroid remnants with high activity 131I (≥28 mCi or ≥ 1.036 GBq).
Key exclusion criteria (4 listed)
- Historical records from patients who meet any of the following criteria will be excluded from this retrospective evaluation:
- Received propylthiouracil, methimazole, vitamins or supplements containing kelp or iodine (taking a multivitamin that does not contain iodine or kelp is acceptable), medications that significantly affect iodine handling such as high dose corticosteroids, high dose diuretics, or lithium in the 45 days before administration of first ablative activity of 131I.
- Received any iodine-containing contrast agents within 3 months prior to first ablative activity of 131I administered.
- Used amiodarone within the 2 years prior to first ablative activity of 131I administered.
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 |
|---|---|---|
| Thyrogen0.9 mg IM, administrated for 2 consecutive days | Drug | Thyrogen and 131I |
| 131I28 mCi or ≥ 1.036 GBq. | Drug | Thyrogen and 131I, Thyroid Hormone Withdrawal and 131I |
| Thyroid Hormone WithdrawalStop taking hormone therapy | Other | Thyroid Hormone Withdrawal and 131I |
Primary outcome
First ablation success rate by Diagnostic Whole Body Scan (DxWBS)
Time frame: at least 6 months after administration of first ablation activity of 131I
3 secondary outcomes
First ablation success rate based on stimulated Thyroglobulin (Tg) levels
Time frame: at least 6 months after administration of first ablation activity of 131I
First ablation success rate based on historical records
Time frame: at least 6 months after administration of first ablation activity of 131I
Number of adverse events of Thyrogen and 131I arm and THW and 131I arm
Time frame: Within 30 days of treatment.
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 23 Mar 2015.
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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.
Medical Monitor study director
Genzyme, a Sanofi Company
9 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Cancer, run by Genzyme, a Sanofi Company at 9 sites in 4 countries.
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 9 inclusion and 4 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 23 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Italy, Spain, Germany, Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
First ablation success rate by Diagnostic Whole Body Scan (DxWBS) (time frame: at least 6 months after administration of first ablation activity of 131I). 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 23 Mar 2015.