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Role of Biomarkers in Endometrial Cancer Recurrence in Samples From Patients With Stage II, Stage III, or Stage IV Endometrial Cancer

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01150682
Enrollment
865
Registered
2010-06-25
Start date
2010-07-31
Completion date
Unknown
Last updated
2011-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrial Cancer

Keywords

endometrial adenocarcinoma, stage II endometrial carcinoma, stage III endometrial carcinoma, stage IV endometrial carcinoma, endometrial adenosquamous cell carcinoma, endometrial clear cell carcinoma, endometrial papillary serous carcinoma

Brief summary

RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. PURPOSE: This research study is studying the role of biomarkers in endometrial cancer recurrence in samples from patients with stage II, stage III, or stage IV endometrial cancer.

Detailed description

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.

Interventions

GENETICRNA analysis
GENETICreverse transcriptase-polymerase chain reaction
OTHERenzyme-linked immunosorbent assay
OTHERimmunohistochemistry staining method
OTHERlaboratory biomarker analysis

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Gynecologic Oncology Group
Lead SponsorNETWORK

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

Inclusion criteria

DISEASE CHARACTERISTICS: * Histologically confirmed endometrioid endometrial cancer * Stage II-IV disease * Patients who were eligible and evaluated on the GOG-0210, Molecular Staging in Endometrial Cancer clinical trial, meeting the following criteria: * Allowed their specimens and clinical data collected as part of their participation * Have sufficient high-quality frozen primary tumor, formalin-fixed and paraffin-embedded (FFPE) primary tumor, and/or pre-operative serum for testing available * Patients who underwent surgical staging as specified in the GOG-0210 protocol and described in the GOG Surgical Manual Protocol, including any of the following procedures: * Hysterectomy * Bilateral oophorectomy * Washings as well as pelvic lymphadenectomy and para-aortic lymphadenectomy * Non-cancerous endometrial tissue and fasting serum from control samples meeting the following criteria (controls): * Underwent hysterectomy to treat uterine prolapse at the Albert Einstein Hospital and Montefiore Medical Center, in the Bronx, NY * No uterine fibroids or prior cancer PATIENT CHARACTERISTICS: * Postmenopausal patients and controls PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Design outcomes

Primary

MeasureTime frame
Patient characteristics: age, BMI, performance status, race, ethnicity
Tumor characteristics
Surgical compliance and type of surgical adjuvant therapy
Overall survival
Recurrence-free survival
Site of first recurrence
Biomarker values and expression levels

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026