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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thyrogen and 131I | Patients were previously treated with Thyrogen in conjunction with a high ablative activity of 131I. |
| |
| Thyroid Hormone Withdrawal and 131I | Patients were previously treated with Thyroid hormone withdrawal (THW) in conjunction with a high ablative activity of 131I. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thyrogen | Drug | 0.9 mg IM, administrated for 2 consecutive days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| First ablation success rate by Diagnostic Whole Body Scan (DxWBS) | at least 6 months after administration of first ablation activity of 131I |
| Measure | Description | Time Frame |
|---|---|---|
| First ablation success rate based on stimulated Thyroglobulin (Tg) levels | at least 6 months after administration of first ablation activity of 131I | |
| First ablation success rate based on historical records | at least 6 months after administration of first ablation activity of 131I |
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Inclusion Criteria:
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).
Historical records are available confirming ablation results by:
Exclusion Criteria:
Historical records from patients who meet any of the following criteria will be excluded from this retrospective evaluation:
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Historical records at clinical sites will be reviewed in a systematic fashion to identify eligible patients.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Genzyme, a Sanofi Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hanover University School of Medicine | Hanover | Germany | ||||
| Klinikum Großhadern |
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| 131I |
| Drug |
28 mCi or ≥ 1.036 GBq. |
|
| Thyroid Hormone Withdrawal | Other | Stop taking hormone therapy |
|
| 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. | Within 30 days of treatment. |
| München |
| Germany |
| Policlinico S.Orsola-Malpighi | Bologna | Italy |
| Instituto Oncologico Veneto | Padova | Italy |
| Istituti Fisioterapici Ospitalieri (IFO) | Rome | Italy |
| Portuguese Institute of Oncology | Coimbra | Portugal |
| Hospital Universitario Reina Sofía | Córdoba | Spain |
| Hospital Universitario Virgen de las Nieves | Granada | Spain |
| Hospital Universitario Dr Peset | Valencia | Spain |
| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004700 | Endocrine System Diseases |
| D013959 | Thyroid Diseases |
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| ID | Term |
|---|---|
| D057073 | Thyrotropin Alfa |
| ID | Term |
|---|---|
| D013972 | Thyrotropin |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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