MR Metabolic Biomarkers for Cervical Cancer
|ClinicalTrials.gov Identifier: NCT01874548|
Recruitment Status : Completed
First Posted : June 11, 2013
Last Update Posted : August 15, 2016
|Condition or disease|
|Uterine Cervical Neoplasms|
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.
|Study Type :||Observational|
|Actual Enrollment :||136 participants|
|Observational Model:||Case Control|
|Official Title:||Magnetic Resonance Study on Metabolism Biomarkers for Cervical Cancer.|
|Study Start Date :||July 2013|
|Primary Completion Date :||June 2016|
|Study Completion Date :||June 2016|
Control group (n=30) comprising surgical candidates with normal cervical tissue will be collected for comparison.
- the amounts of metabolites in uterine cervical tissue [ Time Frame: up to 8 weeks of magnetic resonance imaging and spectroscopy exam ]
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01874548
|Department of Radiology, Chang Gung Memorial Hospital|
|Guishan, Taoyuan, Taiwan, 333|
|Principal Investigator:||Gigin Lin, MD, PhD||Department of Medical Imaging and Intervention, Chang Gung Memorial Hospital|