Clinical Trials Logo

Clinical Trial Summary

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


Clinical Trial Description

PRIMARY OBJECTIVES:

I. 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) II. 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) III. 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) IV. 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) V. Confirm epigenetic biomarkers (differential methylation of CpG island loci) associated with recurrent and disease progression in endometrioid endometrial cancer from GOG-0210. (Project 2) VI. 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) VII. 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) VIII. Estimate the prevalence of HNPCC-related and other forms of inherited endometrial cancer in GOG-0210. (Project 3) IX. Define the relationship between defective DNA mismatch repair and clinical and epidemiological factors in GOG-0210. (Project 3) X. Determine the clinicopathologic significance of mismatch-repair defects including associations with disease-free and overall survival in GOG-0210. (Project 3) XI. 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) XII. 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 XIII. Determine the clinicopathologic significance of ERK substrate expression in primary endometrial cancers from WUSM and GOG-0210. (Project 4) XIV. 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) XV. 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. ;


Study Design

Time Perspective: Retrospective


Related Conditions & MeSH terms


NCT number NCT01199250
Study type Observational
Source Gynecologic Oncology Group
Contact
Status Not yet recruiting
Phase N/A
Start date January 2100

See also
  Status Clinical Trial Phase
Active, not recruiting NCT00217737 - Oxaliplatin, Leucovorin Calcium, and Fluorouracil With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for Stage II Colon Cancer Phase 3
Completed NCT00905710 - Chromoendoscopy to Decrease the Risk of Colorectal Neoplasia in Lynch Syndrome N/A
Active, not recruiting NCT02194387 - Energy Balance Interventions in Increasing Physical Activity in Breast Cancer Gene Positive Patients, Lynch Syndrome-Positive Patients, CLL Survivors or High-Risk Family Members N/A
Recruiting NCT04909671 - Evaluation of ArTificial Intelligence System (Gi-Genius) for adenoMa dEtection in Lynch Syndrome. N/A
Recruiting NCT04379999 - Atorvastatin ± Aspirin in Lynch Syndrome Syndrome Early Phase 1
Recruiting NCT05692596 - The Pancreas Interception Center (PIC) for Early Detection, Prevention, and Novel Therapeutics
Completed NCT01845753 - Molecular Screening for Lynch Syndrome in Denmark
Completed NCT01216930 - Molecular Screening for Lynch Syndrome in Southern Denmark N/A
Not yet recruiting NCT05963191 - CAD-EYE System for the Detection of Neoplastic Lesions in Patients With Lynch Syndrome N/A
Active, not recruiting NCT02912559 - Combination Chemotherapy With or Without Atezolizumab in Treating Patients With Stage III Colon Cancer and Deficient DNA Mismatch Repair Phase 3
Recruiting NCT04978350 - Overcoming Barriers to the Uptake of Cascade Screening for Lynch Syndrome: Workbook Feasibility Study N/A
Active, not recruiting NCT03832985 - Pediatric Reporting of Adult-Onset Genomic Results Early Phase 1
Withdrawn NCT04778566 - Evaluating the Cologuard Test for Use in Lynch Syndrome
Completed NCT02570516 - NBI Versus Indigo Carmine During Colonoscopy in Lynch Syndrome N/A
Completed NCT01823471 - I-Scan For Colon Polyp Detection In HNPCC N/A
Recruiting NCT02813824 - Effect of Chemoprevention by Low-dose Aspirin of New or Recurrent Colorectal Adenomas in Patients With Lynch Syndrome Phase 3
Recruiting NCT05078866 - Cancer Preventive Vaccine Nous-209 for Lynch Syndrome Patients Phase 1/Phase 2
Recruiting NCT03744962 - MSI in Circulatory DNA of Endometrial Cancer
Recruiting NCT04711434 - PD-1 Antibody for The Prevention of Adenomatous Polyps and Second Primary Tumors in Lynch Syndrome Patients Phase 3
Completed NCT04131062 - Trial to Compare eConsent With Standard Consent Among Prospective Biobank Participants N/A