Uterine Cervical Neoplasms Clinical Trial
Official title:
Magnetic Resonance Study on Metabolism 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.
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.
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Observational Model: Case Control, Time Perspective: Prospective
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