MR Metabolic Biomarkers for Cervical Cancer
The purposes of this study are: (1) to develop magnetic resonance (MR) imaging and spectroscopy as surrogate biomarkers for altered cancer metabolism in cervical cancer; (2) to understand the function of human papillomavirus (HPV) infection and autophagy (a cellular catabolic degradation response to stress) in the metabolic alterations in cervical cancer.
Uterine Cervical Neoplasms
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Magnetic Resonance Study on Metabolism Biomarkers for Cervical Cancer.|
- the amounts of metabolites in uterine cervical tissue [ Time Frame: up to 8 weeks of magnetic resonance imaging and spectroscopy exam ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Tumor tissue will be collected during the operation or biopsy and will be store in liquid nitrogen within 5 minutes removal from body. Standard dual phase tissue extraction will be performed for tumor and cell samples for high resolution MRS analysis.
|Study Start Date:||July 2013|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
Control group (n=30) comprising surgical candidates with normal cervical tissue will be collected for comparison.
In the first part of this project, we aim to identify the differences in cancer metabolism between normal and cervical cancer. Conventional MR study plus magnetic resonance spectroscopy (MRS) and diffusion weighted imaging (DWI) sequences will be carried out on 30 eligible surgical candidates for pretreatment clinical assessment. Metabolites in cancer tissue will be collected during operation and analyzed using high resolution MRS, and compared with control group comprising 30 patients with normal cervical tissue. The primary endpoint of this part is to identify different MRS profiles between normal and cancer subjects. We will investigate the underlying biological mechanism between these two groups by evaluating status of HPV infection and autophagy. In the second part, we aim to understand cancer metabolism in cervical cancers infected by different types of HPV. We plan to enroll another 30 surgical candidates and complete the data regarding clinical MRS/DWI and tissue high resolution MRS. Together with the 30 cancer subjects in part one there will be in total 60 cancer subjects for analysis. The primary endpoint of this part is to compare MRS profiles from cancer tissue infected with different HPV genotypes, particularly HPV type 16 and HPV type 18. The secondary endpoint is to correlate the tissue MRS profiles with the in vivo MRS/DWI measured by clinical MR scanner. In the third part of this project, we aim to investigate cancer metabolism under combined chemoradiation therapy (CCRT). We plan to enroll 60 patients primarily treated with CCRT and collect the data using clinical MR and tissue high-resolution MRS. Tissue MRS profiles will be correlated with the HPV, E6/E7 and autophagy.
The advance in knowledge of this project is to unwire the complex relationship among cancer metabolism, HPV infection and autophagy in cervical cancer. The clinical impact is the development of MR biomarkers for cancer metabolism and autophagy, both play important roles in the resistance to cancer therapy. The inherited non-invasiveness and non-radiation nature makes MR technique an ideal platform for clinical usage.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01874548
|Contact: Gigin Lin, MD, PhD||886-3281200 ext firstname.lastname@example.org|
|Department of Radiology, Chang Gung Memorial Hospital||Recruiting|
|Guishan, Taoyuan, Taiwan, 333|
|Contact: Gigin Lin, MD, PhD 886-3-3281200 ext 2575 email@example.com|
|Principal Investigator:||Gigin Lin, MD, PhD||Department of Medical Imaging and Intervention, Chang Gung Memorial Hospital|