A Retrospective Observational Study Comparing Two Different Treatment Options in Thyroid Cancer Patients With T4 Tumours

March 19, 2015 updated by: Genzyme, a Sanofi Company

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
144

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hannover, Germany
        • Hanover University School of Medicine
      • München, Germany
        • Klinikum Großhadern
  • Italy
      • Bologna, Italy
        • Policlinico S.Orsola-Malpighi
      • Padova, Italy
        • Instituto Oncologico Veneto
      • Rome, Italy
        • Istituti Fisioterapici Ospitalieri (IFO)
  • Portugal
      • Coimbra, Portugal
        • Portuguese Institute of Oncology
  • Spain
      • Cordoba, Spain
        • Hospital Universitario Reina Sofia
      • Granada, Spain
        • Hospital Universitario Virgen de Las Nieves
      • Valencia, Spain
        • Hospital Universitario Dr Peset

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Historical records at clinical sites will be reviewed in a systematic fashion to identify eligible patients.

Description

Inclusion Criteria:

Historical records from patients who meet all of the following criteria will be eligible for inclusion in this retrospective evaluation:

  1. Male or female patients living or deceased, aged 18 years or older at the time of first ablation for thyroid cancer.
  2. 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.
  3. Undergone a near-total or total thyroidectomy on or after 01 January 2000
  4. Undergone first ablation of thyroid remnants with high activity 131I (≥28 mCi or ≥ 1.036 GBq).
  5. 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).

  6. 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.

Exclusion Criteria:

Historical records from patients who meet any of the following criteria will be excluded from this retrospective evaluation:

  1. 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.
  2. Received any iodine-containing contrast agents within 3 months prior to first ablative activity of 131I administered.
  3. Used amiodarone within the 2 years prior to first ablative activity of 131I administered.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Thyrogen and 131I
Patients were previously treated with Thyrogen in conjunction with a high ablative activity of 131I.
Drug: Thyrogen
0.9 mg IM, administrated for 2 consecutive days
Drug: 131I
28 mCi or ≥ 1.036 GBq.
Thyroid Hormone Withdrawal and 131I
Patients were previously treated with Thyroid hormone withdrawal (THW) in conjunction with a high ablative activity of 131I.
Drug: 131I
28 mCi or ≥ 1.036 GBq.
Other: Thyroid Hormone Withdrawal
Stop taking hormone therapy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
First ablation success rate by Diagnostic Whole Body Scan (DxWBS)
Time Frame: at least 6 months after administration of first ablation activity of 131I
at least 6 months after administration of first ablation activity of 131I

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
First ablation success rate based on stimulated Thyroglobulin (Tg) levels
Time Frame: at least 6 months after administration of first ablation activity of 131I
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
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.
Exploratory safety assessment in patients with T4 tumour for first ablation of thyroid remnants based on historical records.
Within 30 days of treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Genzyme, a Sanofi Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 26, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 26, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 29, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 23, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • THYR04910

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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