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Biomarkers in Samples From Patients With Endometrial Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by National Cancer Institute (NCI).
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01199250
First received: September 9, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted
  Purpose

RATIONALE: Studying samples from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is studying biomarkers in samples from patients with endometrial cancer.


Condition Intervention
Endometrial Cancer
Hereditary Non-polyposis Colon Cancer
Genetic: DNA analysis
Genetic: DNA methylation analysis
Genetic: gene expression analysis
Genetic: molecular genetic technique
Genetic: mutation analysis
Genetic: polymorphism analysis
Genetic: reverse transcriptase-polymerase chain reaction
Genetic: western blotting
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis

Study Type: Observational
Official Title: Specialized Program of Research Excellence (SPORE) in Endometrial Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Rate and spectrum of mutations in fibroblast growth factor receptor 2 (FGFR2) (Project 1) [ Designated as safety issue: No ]
  • Relationship between FGFR2 mutation and clinicopathologic (CP) variables (Project 1) [ Designated as safety issue: No ]
  • Identification of the cognate FGF ligands and receptors expressed in normal endometrium and endometrial cancers and their expression on multiple tissue microarrays (Project 1) [ Designated as safety issue: No ]
  • Epigenetic biomarkers associated with recurrence and disease progression (Project 2) [ Designated as safety issue: No ]
  • Development of a molecular-screening regimen to compliment family history risk assessment to identify carriers of Hereditary Non-Polyposis Colorectal Cancer (HNPCC)-related and other forms of inherited endometrial cancer (Project 3) [ Designated as safety issue: No ]
  • Relationship between defective DNA mismatch repair and clinical and epidemiological factors (Project 3) [ Designated as safety issue: No ]
  • CP significance of mismatch-repair defects (Project 3) [ Designated as safety issue: No ]
  • Expression and relationships of five candidate ERK1/2 substrates, and substrate phosphorylation, and ERK signaling pathway activation (Project 4) [ Designated as safety issue: No ]
  • CP significance of ERK substrate expression (Project 4) [ Designated as safety issue: No ]

Estimated Enrollment: 3600
Study Start Date: October 2010
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Assess the frequency and spectrum of mutations in fibroblast growth factor receptor 2 (FGFR2) in low-, intermediate-, and/or high-risk endometrioid endometrial cancer from GOG-0210. (Project 1)
  • Determine the relationship between FGFR2 mutation and clinicopathologic variables including disease-free and overall survival in low-, intermediate-, and/or high-risk endometrial cancer from GOG-0210. (Project 1)
  • Identify the cognate FGF ligands and receptors expressed in normal endometrium and endometrial cancers, and examine their expression on multiple tissue microarrays for GOG-0210 to determine their association with clinical outcome. (Project 1)
  • Identify epigenetic biomarkers (differential methylation of CpG island loci) associated with recurrence and disease progression in endometrioid endometrial cancer from Washington University School of Medicine (WUSM). (Project 2)
  • Confirm epigenetic biomarkers (differential methylation of CpG island loci) associated with recurrent and disease progression in endometrioid endometrial cancer from GOG-0210. (Project 2)
  • Define the performance (sensitivity and specificity) of epigenetic biomarkers associated with recurrence and disease progression in endometrioid endometrial cancer from an independent cohort of cases from GOG-0210. (Project 2)
  • Develop a molecular screening regimen to compliment family history risk assessment to identify carriers of Hereditary Non-Polyposis Colorectal Cancer (HNPCC)-related and other forms of inherited endometrial cancer from GOG-0210 that was not ascertained by family history. (Project 3)
  • Estimate the prevalence of HNPCC-related and other forms of inherited endometrial cancer in GOG-0210. (Project 3)
  • Define the relationship between defective DNA mismatch repair and clinical and epidemiological factors in GOG-0210. (Project 3)
  • Determine the clinicopathologic significance of mismatch-repair defects including associations with disease-free and overall survival in GOG-0210. (Project 3)
  • Assess expression of five candidate ERK1/2 substrates in the normal endometrium, primary endometrial cancers (from WUSM and GOG-0210) and endometrial cancer cell lines and determine if substrate phosphorylation is ERK-dependent. (Project 4)
  • Determine the relationship between ERK substrate-phosphorylation status and upstream ERK-signaling pathway activation in primary endometrial cancers from WUSM and GOG-0210. (Project 4)
  • Determine the clinicopathologic significance of ERK substrate expression in primary endometrial cancers from WUSM and GOG-0210. (Project 4)
  • Explore GSK3/3 inhibition as a therapeutic treatment of endometrial cancer and assess the role of inhibiting other ERK substrates in endometrial cell lines. (Project 4)
  • Explore the predictive and prognostic accuracy of a panel of single nucleotide polymorphisms alone and with informative clinical, surgical, and pathologic variables in a cohort of Caucasian women with stage IB or IC vs IIIC endometrioid endometrial cancer from WUSM and GOG-0210. (Project 5)

OUTLINE: This is a multicenter study.

Previously collected samples are analyzed for biomarker and other laboratory analyses.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Samples available from one of the following:

    • GOG-0210
    • Washington University School of Medicine Siteman Cancer Center

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01199250

Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Principal Investigator: Paul J. Goodfellow, PhD Washington University Siteman Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Philip J. DiSaia, Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT01199250     History of Changes
Other Study ID Numbers: CDR0000684553, GOG-8020
Study First Received: September 9, 2010
Last Updated: September 9, 2010
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
hereditary non-polyposis colon cancer
recurrent endometrial carcinoma
stage I endometrial carcinoma
stage II endometrial carcinoma
stage III endometrial carcinoma
stage IV endometrial carcinoma

Additional relevant MeSH terms:
Colorectal Neoplasms, Hereditary Nonpolyposis
Endometrial Neoplasms
Colonic Diseases
Colorectal Neoplasms
DNA Repair-Deficiency Disorders
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Genetic Diseases, Inborn
Genital Diseases, Female
Genital Neoplasms, Female
Intestinal Diseases
Intestinal Neoplasms
Metabolic Diseases
Neoplasms
Neoplasms by Site
Neoplastic Syndromes, Hereditary
Urogenital Neoplasms
Uterine Diseases
Uterine Neoplasms

ClinicalTrials.gov processed this record on November 20, 2014