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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. completion date
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


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
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