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

Endometrial Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01150682
• Other study ID #: CDR0000680598
• Secondary ID: GOG-8015
• Status: Active, not recruiting
• Phase: N/A
• First received: June 24, 2010
• Last updated: April 28, 2011
• Start date: July 2010

Study information

• Verified date: August 2010
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 865
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms

Intervention

Genetic:
• RNA analysis

• reverse transcriptase-polymerase chain reaction

Other:
• enzyme-linked immunosorbent assay

• immunohistochemistry staining method

• laboratory biomarker analysis

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Gynecologic Oncology Group	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient characteristics: age, BMI, performance status, race, ethnicity			No
Primary	Tumor characteristics			No
Primary	Surgical compliance and type of surgical adjuvant therapy			No
Primary	Overall survival			No
Primary	Recurrence-free survival			No
Primary	Site of first recurrence			No
Primary	Biomarker values and expression levels			No

External Links

•   Clinical trial summary from the National Cancer Institute's PDQ® database