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| ID | Type | Description | Link |
|---|---|---|---|
| Protocol Ver October 2020 | Other Identifier | UW Madison | |
| A539711 | Other Identifier | UW Madison | |
| SMPH/SURGERY/ENDOCRINE | Other Identifier | UW Madison |
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This pilot project will randomize a small sample of patients about to undergo surgery for their autoimmune, inflammatory thyroid disease, and determine if a short course of prednisone alters the inflammation of the gland and makes surgery less difficult. It will enroll 30 participants who will each be on study for up to 7 months.
Graves' disease and Hashimoto's thyroiditis are autoimmune conditions affecting the thyroid gland. Surgery to remove the thyroid gland in these patients may be complicated by the inflammatory nature of these diseases. Prednisone is a steroid medication used to decrease inflammation of the thyroid gland in other disease states such as sub-acute thyroiditis, but has not been used systematically to reduce inflammation in patients about to undergo surgery.
This is a pilot project that proposes to randomize a small sample of patients about to undergo surgery for their autoimmune, inflammatory thyroid disease, and determine if a short course of prednisone alters the inflammation of the gland and makes surgery less difficult. This could potentially lead to better outcomes for these patients, as well as increased time to recovery and improved quality of life.
This project proposes to administer short quality of life surveys at three time points, as well as draw additional labs to measure inflammation and antibody levels at times when patients will already be getting labs drawn for clinical purposes. The purpose of this study is to generate preliminary data from which a larger, blinded, placebo-controlled trial could be designed.
These specific aims are:
Determine the benefits and safety of preoperatively administered prednisone for patients with autoimmune thyroid disease undergoing thyroidectomy on:
Longitudinally assess the impact of surgical treatment on QoL in patients with autoimmune thyroid disease
Update: Protocol amendment approved on 10-22-2020: Study team decided to omit the aim 'antibody-mediated cytokine levels' from the protocol and consent process as it became cost-prohibitive for processing and storage fees. Cytokine levels are not something typically collected or tracked in the course of clinical care, and may not be relevant. Study can proceed without this aim and will not alter the main outcome measures of antibody levels and difficulty of the operation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Steroids | Active Comparator | Participants randomized to the steroid arm will be given a prescription for prednisone 20mg daily for 7 days prior to surgery, otherwise, pre-operative standard of care |
|
| No Steroids | No Intervention | Pre-operative Standard of Care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prednisone | Drug | used to reduce inflammation |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Thyroid Difficulty Scale Score | The surgeon will fill out the "Thyroid Difficulty Scale" at the conclusion of the operation. This is a 4-item survey to rate the vascularity, friability, mobility, and glandular size of the thyroid. The total possible range of scores from 4-20, higher scores indicate increased difficulty in thyroid surgery | surgery occurs up to 4 weeks, data collected a conclusion of operation |
| Percent Change From Baseline Mean in Autoantibody Levels | Autoantibodies that may be positive include: Thyroglobulin Antibody [TgAb], Thyroid peroxidase antibody [TPO], Thyroid Stimulating Ig antibody [TSI], and/or Thyrotropin Receptor antibody [TRAb]. Any that were positive pre-op will be measured at each time point. Baseline level will be 1. | baseline measure day of surgery (up to 4 weeks), up to 6 weeks (2 weeks post-op), up to 10 weeks (6 weeks post-op), up to 30 weeks (6 months post-op) |
| Change in Antibody-mediated Cytokine Levels | Antibody-mediated cytokine levels will be measured using a 10 cytokine panel from Luminex. Cytokines that have been implicated in other autoimmune disease include: IFN-gamma (BR29), IL-6 (BR13), IL-10 (BR22), IL-13 (BR47), IL-15 (BR63), IL-17A (BR42), and VEGF-C (BR38). | baseline (2-4 weeks prior to surgery), up to 4 weeks (Post Operative Day 1), up to 6 weeks (2 weeks post-op), up to 30 weeks (6 months post-op) |
| Change in Short Form Health Survey (SF-12) Mental Component Score (MCS) | The SF-12 is a 12-item quality of life survey to understand how the participant feels and how well they are able to do their normal activities, it is composed of the mental component score and the physical component score. Each is scored on a scale of 0-100, with higher numbers indicating higher quality of life. | baseline (2-4 weeks prior to surgery), up to 10 weeks (6 weeks post-op), up to 30 weeks (6 months post-op) |
| Measure | Description | Time Frame |
|---|---|---|
| Ultrasound Doppler Quantification of Blood Flow | baseline (2-4 weeks prior to surgery), up to 4 weeks (Post Operative Day 1) | |
| Surgical Complications: Parathyroid Hormone (PTH) Level | PTH is measured right after surgery to determine whether the nearby parathyroid glands were injured during surgery. Low PTH levels immediately after surgery are concerning for symptomatic low calcium levels, either temporarily or permanent, after thyroidectomy. Normal PTH is typically between 20-70. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dawn K Elfenbein | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin Hospital and Clinics | Madison | Wisconsin | 53792 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Steroids | Participants randomized to the steroid arm will be given a prescription for prednisone 20mg daily for 7 days prior to surgery, otherwise, pre-operative standard of care Prednisone: used to reduce inflammation |
| FG001 | No Steroids | Pre-operative Standard of Care |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Steroids | Participants randomized to the steroid arm will be given a prescription for prednisone 20mg daily for 7 days prior to surgery, otherwise, pre-operative standard of care Prednisone: used to reduce inflammation |
| BG001 | No Steroids |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Thyroid Difficulty Scale Score | The surgeon will fill out the "Thyroid Difficulty Scale" at the conclusion of the operation. This is a 4-item survey to rate the vascularity, friability, mobility, and glandular size of the thyroid. The total possible range of scores from 4-20, higher scores indicate increased difficulty in thyroid surgery | Posted | Mean | Standard Deviation | score on a scale | surgery occurs up to 4 weeks, data collected a conclusion of operation |
|
up to 6 months post-operatively
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Steroids | Participants randomized to the steroid arm will be given a prescription for prednisone 20mg daily for 7 days prior to surgery, otherwise, pre-operative standard of care Prednisone: used to reduce inflammation |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| insomnia | Psychiatric disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dawn Elfenbein, MD, MPH, FACS | University of Wisconsin - Madison School of Medicine and Public Health | (608) 263-1387 | elfenbein@surgery.wisc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 22, 2020 | Sep 20, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013959 | Thyroid Diseases |
| D001327 | Autoimmune Diseases |
| D006111 | Graves Disease |
| D050031 | Hashimoto Disease |
| ID | Term |
|---|---|
| D004700 | Endocrine System Diseases |
| D007154 | Immune System Diseases |
| D005094 | Exophthalmos |
| D009916 | Orbital Diseases |
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| ID | Term |
|---|---|
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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randomized controlled pilot study
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| Change in Short Form Health Survey (SF-12) Physical Component Score (PCS) |
The SF-12 is a 12-item quality of life survey to understand how the participant feels and how well they are able to do their normal activities, it is composed of the mental component score and the physical component score. Each is scored on a scale of 0-100, with higher numbers indicating higher quality of life. |
| baseline (2-4 weeks prior to surgery), up to 10 weeks (6 weeks post-op), up to 30 weeks (6 months post-op) |
| Change in Thyroid-specific Quality of Life Patient-reported Outcome Measure for Benign Thyroid Disorders (ThyPRO) Score | The ThyPRO survey is a quality of life measure designed to evaluate how thyroid disease has affected the participant's life. It is a 39-item survey that was scored from 0-4, higher scores indicate worse quality of life. | baseline (2-4 weeks prior to surgery), up to 10 weeks (6 weeks post-op), up to 30 weeks (6 months post-op) |
| immediately after surgery (baseline for all participants) |
| Number of Participants With Surgical Complications: Recurrent Laryngeal Nerve (RLN) Injury | up to 4 weeks (Post Operative Day 1) |
Pre-operative Standard of Care |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Number of Participants with Body Mass Index greater than or equal to 35 | Body Mass Index (BMI) is a person's weight in kilograms divided by their height in meters squared. BMI over 30 is characterized as obese. | Count of Participants | Participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| Diagnosis | Count of Participants | Participants |
|
Pre-operative Standard of Care
|
|
| Primary | Percent Change From Baseline Mean in Autoantibody Levels | Autoantibodies that may be positive include: Thyroglobulin Antibody [TgAb], Thyroid peroxidase antibody [TPO], Thyroid Stimulating Ig antibody [TSI], and/or Thyrotropin Receptor antibody [TRAb]. Any that were positive pre-op will be measured at each time point. Baseline level will be 1. | Posted | Mean | Standard Deviation | percent change from baseline mean | baseline measure day of surgery (up to 4 weeks), up to 6 weeks (2 weeks post-op), up to 10 weeks (6 weeks post-op), up to 30 weeks (6 months post-op) |
|
|
|
| Primary | Change in Antibody-mediated Cytokine Levels | Antibody-mediated cytokine levels will be measured using a 10 cytokine panel from Luminex. Cytokines that have been implicated in other autoimmune disease include: IFN-gamma (BR29), IL-6 (BR13), IL-10 (BR22), IL-13 (BR47), IL-15 (BR63), IL-17A (BR42), and VEGF-C (BR38). | Investigators did not collect cytokines, as originally planned, as they did not have the storage space or equipment they initially thought. | Posted | baseline (2-4 weeks prior to surgery), up to 4 weeks (Post Operative Day 1), up to 6 weeks (2 weeks post-op), up to 30 weeks (6 months post-op) |
|
|
| Primary | Change in Short Form Health Survey (SF-12) Mental Component Score (MCS) | The SF-12 is a 12-item quality of life survey to understand how the participant feels and how well they are able to do their normal activities, it is composed of the mental component score and the physical component score. Each is scored on a scale of 0-100, with higher numbers indicating higher quality of life. | Posted | Mean | Standard Deviation | score on a scale | baseline (2-4 weeks prior to surgery), up to 10 weeks (6 weeks post-op), up to 30 weeks (6 months post-op) |
|
|
|
| Primary | Change in Short Form Health Survey (SF-12) Physical Component Score (PCS) | The SF-12 is a 12-item quality of life survey to understand how the participant feels and how well they are able to do their normal activities, it is composed of the mental component score and the physical component score. Each is scored on a scale of 0-100, with higher numbers indicating higher quality of life. | Posted | Mean | Standard Deviation | score on a scale | baseline (2-4 weeks prior to surgery), up to 10 weeks (6 weeks post-op), up to 30 weeks (6 months post-op) |
|
|
|
| Primary | Change in Thyroid-specific Quality of Life Patient-reported Outcome Measure for Benign Thyroid Disorders (ThyPRO) Score | The ThyPRO survey is a quality of life measure designed to evaluate how thyroid disease has affected the participant's life. It is a 39-item survey that was scored from 0-4, higher scores indicate worse quality of life. | Not all participants provided survey data for all time points. | Posted | Mean | Full Range | score on a scale | baseline (2-4 weeks prior to surgery), up to 10 weeks (6 weeks post-op), up to 30 weeks (6 months post-op) |
|
|
|
| Secondary | Ultrasound Doppler Quantification of Blood Flow | Investigators were unable to come up with a system to quantify doppler flow, so data were not collected | Posted | baseline (2-4 weeks prior to surgery), up to 4 weeks (Post Operative Day 1) |
|
|
| Secondary | Surgical Complications: Parathyroid Hormone (PTH) Level | PTH is measured right after surgery to determine whether the nearby parathyroid glands were injured during surgery. Low PTH levels immediately after surgery are concerning for symptomatic low calcium levels, either temporarily or permanent, after thyroidectomy. Normal PTH is typically between 20-70. | Posted | Mean | Standard Deviation | pg/mL | immediately after surgery (baseline for all participants) |
|
|
|
| Secondary | Number of Participants With Surgical Complications: Recurrent Laryngeal Nerve (RLN) Injury | Posted | Count of Participants | Participants | up to 4 weeks (Post Operative Day 1) |
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 9 |
| 14 |
| EG001 | No Steroids | Pre-operative Standard of Care | 0 | 16 | 0 | 16 | 2 | 16 |
| mood changes | Psychiatric disorders | Systematic Assessment |
|
| Gastrointestinal Upset | Gastrointestinal disorders | Systematic Assessment |
|
| increased appetite | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Nerve Injury | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Shortness of Breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | Systematic Assessment |
|
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| D005128 |
| Eye Diseases |
| D006042 | Goiter |
| D006980 | Hyperthyroidism |
| D013967 | Thyroiditis, Autoimmune |
| D013966 | Thyroiditis |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| surgery to 6 months post-op |
|
| 6 months post-op |
|
| 6 months post-op |
|
| 6 weeks post-op |
|
|
| 6 months post-op |
|
|