Biomarkers in Blood and Tissue Samples From Patients With Uterine Cancer

NCT01344837 | Completed

• 6 other identifiers: GOG-8023NCI-2011-02872CDR0000698458R21CA135467U10CA027469U10CA037517
• Study Type: observational
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

This research study is studying biomarkers in blood and tissue samples from patients with uterine cancer. Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors learn more about changes the occur in DNA and identify biomarkers related to cancer.

Conditions

Endometrial Serous Adenocarcinoma; Stage I Uterine Corpus Cancer; Stage II Uterine Corpus Cancer; Stage III Uterine Corpus Cancer; Stage IV Uterine Corpus Cancer

Outcome Measures

Primary Outcomes (1)

• Overall survival

  Kaplan-Meier survival curves for the overall survival (OS) endpoint will be generated separately for the three SNCG expression groups and globally compared using a log-rank test.

  From time of entry onto GOG-0210, assessed up to 2 years

Secondary Outcomes (2)

• Presence of synchronous or metachronous breast cancer

  Up to 2 years

• Progression-free survival

  From time of entry onto GOG-0210 to time of progression, assessed up to 2 years

Study Arms (1)

Observational

Archived serum and tumor tissue samples are analyzed for synuclein-γ (SNCG) expression and other biomarker expression, including TP53 (p53), HER-2, folate receptor alpha (FOLR1), estrogen receptor (ER), progesterone receptor (PR), phosphatase and tensin homolog (PTEN), phosphorylated AKT (pAKT), pERK, and p16 by microarray analysis, IHC assays, and western blot. Results are then compared with patients' existing clinical, demographic, and pathology data, including history of breast cancer (metachronous) or breast cancer diagnosed at the same time as the endometrial cancer (synchronous).

Other: Diagnostic Laboratory Biomarker Analysis; Other: Immunohistochemistry Staining Method; Other: Medical Chart Review; Genetic: Microarray Analysis; Other: Study of Socioeconomic and Demographic Variables; Genetic: Western Blotting

Interventions

Diagnostic Laboratory Biomarker Analysis OTHER

Correlative studies

Observational

Immunohistochemistry Staining Method OTHER

Correlative studies

Also known as: Cell/Tissue, Immunohistochemistry, IHC, Immunohistochemistry

Observational

Medical Chart Review OTHER

Correlative studies

Also known as: Chart Review

Observational

Microarray Analysis GENETIC

Correlative studies

Also known as: gene expression profile, Gene Expression Profiling, Microarray Technology, Microarray-Based Analysis

Observational

Study of Socioeconomic and Demographic Variables OTHER

Correlative studies

Observational

Western Blotting GENETIC

Correlative studies

Also known as: Blotting, Western, WESTERN BLOT

Observational

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with uterine cancer

You may qualify if:

• Women with uterine papillary serous carcinoma (UPSC) who were eligible for GOG-0210 protocol, a molecular staging study in endometrial cancer, or GOG-0136, a general specimen banking study for gynecologic cancer, have consented to future research, have histologically-confirmed UPSC of any stage, and have satisfactory formalin-fixed and paraffin-embedded primary tumor with or without a satisfactory pre-operative serum specimen available for testing
• Women with endometrioid endometrial cancer who were eligible for GOG-0210 or GOG-0136, have consented to future research, have histologically-confirmed endometrioid endometrial carcinoma with a similar stage, age and race/ethnicity distribution as the UPSC patients, have satisfactory formalin-fixed and paraffin-embedded primary tumor and/or pre-operative serum specimen available for testing
• Normal healthy control women who participated in the Biopathology protocol for banking sera from normal healthy control women, have consented to future research, do not have a cancer or a history of cancer and have a similar age and race/ethnicity distribution as the UPSC patients and have satisfactory serum available for testing

Sponsors & Collaborators

• Gynecologic Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Gynecologic Oncology Group

Philadelphia, Pennsylvania, 19103, United States

Location

MeSH Terms

Interventions

Immunohistochemistry; Microarray Analysis; Transcriptome; Gene Expression Profiling; Blotting, Western

Intervention Hierarchy (Ancestors)

Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Investigative Techniques; Immunologic Techniques; Microchip Analytical Procedures; Transcription, Genetic; Biochemical Phenomena; Chemical Phenomena; Gene Expression; Genetic Phenomena; Genetic Structures; Genetic Techniques; Electrophoresis; Chemistry Techniques, Analytical; Electrochemical Techniques; Immunoblotting; Immunoassay; Molecular Probe Techniques

Study Officials

• Barbara Buttin

  Gynecologic Oncology Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2011
• First Posted: April 29, 2011
• Study Start: January 1, 2010
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: August 14, 2024

Record last verified: 2024-08

Locations

US (1)