2. 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.
3. 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.
4. 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
5. “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
6. 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.
7. 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.
8. 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.
9. 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.
10. 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.
11. 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.
