Niccola Piscitelli

Having had thyroid cancer when I was 27 years of age intrigued me to create this study.

Many patients with Thyroid Cancer undergo radioactive iodine ablation (RAI) to remove residual thyroid tissue after surgery.

Patients have to go through temporary thyroid hormone withdrawal 2-4 weeks before ablation, during this time hypothyroidism develops in the patients and reduces their quality of life.

Thyroid hormone withdrawal can be avoided with the use of the drug Thyrogen.

There is uncertainty if using Thyrogen reduces rates of ablation success & recurrence, especially with low dose of radioiodine.

This study is to determine if Caucasian female papillary thyroid cancer patients between the ages of 20-30 who undertake RAI with Thyrogen have a less chance of recurrence of cancer.

Data base articles: “Ablation with Low Dose Radioiodine &

Thyrotropin Alfa in Thyroid Cancer”, Ujjal Mallick, F.R.C.R, Clive Harmer, F.R.C.P, Beng Yap, F.R.C.P, May 2012

“Recombinant human-thyroid-stimulating hormone as an alternative for thyroid hormone withdrawal in thyroid cancer management”, Ming-Kai Chen, Idukala Doddammne, David Cheng, January 2010

“The use of recombinant Human Thyrotropin (Thyrogen) in the Diagnosis & treatment of Thyroid Cancer”, Leonides H. Duntas, July 2003

“Five year longitudinal evaluation of quality of life in a cohort of patients with Differentiated Thyroid Carcinoma”, Massimo Giusti, Melle Giula, Monica Fennocchio, November 2010

“Sick Leave for follow-up control in thyroid cancer patients: Comparison between stimulation with Thyrogen and Thyroid hormone withdrawal.”, Borget, I., May 2007

If Caucasian female patients between the ages of 20-30 with a history of papillary thyroid cancer use Thyrogen instead of going through thyroid hormone withdrawal during their radioactive iodine treatments (RAI) and whole body scans (WBS), then they have a better quality of life and less chance of recurrence or metastasis of cancer.

Patient population will be randomly selected from THYCA (Thyroid Cancer Survivor Network). Patients will be Caucasian, female and between the ages of 20-30.

The Control Group and Experimental Group will have 100 Caucasian female patients (between 20-30 years old) in each group who had papillary thyroid carcinoma, underwent a Total Thyroidectomy (TT) and are about to go through Radio Active Iodine Ablation (RAI).

The study will begin before their RAI treatment 1-6 months and after their TT. Thyroid hormone replacement will be ceased 4 weeks before RAI and low iodine diet will be administered. Same procedure for WBS.

Patients will undergo pre and post medical exams prior to RAI/WBS for both procedures. A cross-sectional longitudinal cohort study will be used to assess both groups over a 10 year period.

Both the control group and experimental group will be medically tracked by medical condition, and recurrence rate.

The patients will be monitored by physical exams, questionnaires about their health and their medical test results of scans completed over the 10 year period. This will monitor recurrence rates of cancer for both groups.

Web questionnaires will be available through THYCA website for each patient to record answers as to their health and medical progress. The questions will be mostly close-ended questions to determine if patients had any recurrence. A few open-ended questions will be asked to fill in any blanks or allow patients to embellish any missing info from closed-ended questions.

Doctor’s will monitor every patient and record their medical progress and prognosis over the 10 year study. All WBS scans and recurrence rate by thyroid area, lymph nodes, breast or colon cancer will be noted and statistically compared.

The mean and mode of the recurrence of cancer will be compared for both groups of patients.

Univariate Analysis will be used to acquire the averages of recurrence of cancer for each age group in the 2 groups will be compared and assessed as to if the Thyrogen group had fewer cancer recurrences over the 10 year study. Mode can also be analyzed to see which rates are the most common for both groups.

Through bivariate analysis a cross tab analysis will be used to compare the control group and the experimental group using Thyrogen.

I believe the Thyrogen group will statistically have less incidence of recurrence of cancer than the control group that has to undergo withdrawal of the thyroid hormone naturally. The range can be used to demonstrate the high levels of recurrence of cancer versus the lower levels of recurrence.

A “T” test will be used to compare the % of patients in the Thyrogen users compared to the non-Thyrogen users to see if it is statistically significant.

Conclusions for the study will be based upon the statistical information gathered by comparing the T test and statistical info from both the control group and the experimental group.

Based on previous studies of Thyrogen the results of this particular study will find that the recurrence rate for the control group will be about 15% more than the experimental drug taking the Thyrogen.

I would accept the hypothesis of the recurrence rate being less for the Thyrogen users compared to Non-Thyrogen users for Caucasian women between the ages of 20-30.