Trial Information

Role of Sex Hormone and Insulin/IGF Axes in Endometrial Cancer Recurrence

OBJECTIVES:

- To investigate the association of endometrioid adenocarcinoma (EA) recurrence with
pre-operative serum levels of insulin, total and free insulin-like growth factor-I
(IGF-I), IGF-II, insulin-like growth factor-binding protein-1 (IGFBP-1) and IGFB-3,
estradiol, estrone, progesterone, and sex hormone-binding globulin (SHBG) in samples
from patients with stage II-IV endometrial cancer evaluated on GOG-0210.

- To study the associations of EA recurrence with pre-treatment tumor expression of
IGF-I, IGF-II, and IGFBP-1 and -3 mRNA in samples from these patients.

- To study the associations of EA recurrence with pre-treatment tumor expression of
insulin receptor, IGF-I receptor, estrogen receptor, and progesterone receptor in
samples from these patients.

- To measure the correlations of serum (protein) and tissue (mRNA) levels of IGF-I,
IGF-II, and IGFBP-1 and -3 from samples of patients with EA and participants without
cancer.

OUTLINE: Banked serum and tumor tissues samples are analyzed for levels of insulin, total
and free insulin-like growth factor (IGF-I), IGF-II, IGFBP-1 and IGFBP-3, estradiol,
estrone, progesterone and sex hormone-binding globulin (SHBG); expression of IGF-I, IGF-II,
IGFBP-1 and IGFBP -3 mRNA; and expression of the insulin receptor, IGF-I receptor, estrogen
receptor, and progesterone receptor by RT-PCR, IHC, and ELISA. Banked non-cancerous
endometrial tissue and fasting serum samples from controls are also analyzed for IGF-I,
IGF-II, IGFBP-1, and IGFBP-3 and compared with the results of endometrial adenocarcinoma
(EA) samples.

Clinical information associated with each EA samples (i.e., age, BMI, performance status,
race, ethnicity, tumor stage, size, histology and grade, surgical compliance and type of
post surgical adjuvant therapy, overall survival, recurrence-free survival, site of first
recurrence, and biomarker values and expression) is also collected.

PROJECTED ACCRUAL: A total of 815 patient specimens and 50 control specimens will be accrued
for this study.