Magnetic Resonance Study on Metabolism Biomarkers for Cervical Cancer.

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Chang Gung Memorial Hospital
Sponsor:
Information provided by (Responsible Party):
Gigin Lin, MD, PhD, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01874548
First received: June 6, 2013
Last updated: July 5, 2013
Last verified: July 2013

June 6, 2013
July 5, 2013
July 2013
June 2016   (final data collection date for primary outcome measure)
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 ]
the amounts of metabolites in uterine cervical tissue [ Time Frame: during surgery or cervical biopsy ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01874548 on ClinicalTrials.gov Archive Site
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Magnetic Resonance Study on Metabolism Biomarkers for Cervical Cancer.
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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
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample

Patients in a tertiary referral center.

Uterine Cervical Neoplasms
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  • Normal cervix
  • Cervical cancer
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
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June 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • be able to give informed consent.
  • female patients between 20 and 80 years of age.
  • biopsy proven newly diagnosed cervical cancer clinical stage International Federation of Gynecology and Obstetrics (FIGO) Ib and above.
  • patients must be willing to undergo standard treatment such as surgery or chemo-radiation therapy.

Exclusion Criteria:

  • patients who are judged to be noncompliant to treatment or not accessible for follow up.
  • patients with contraindications to magnetic resonance imaging (MRI) scanning, such as claustrophobia, cardiac pacemaker, metal implants in field of view, or unable to cooperate for MRI study due to mental status.
Female
20 Years to 80 Years
Yes
Contact: Gigin Lin, MD, PhD 886-3281200 ext 2575 giginlin@cgmh.org.tw
Taiwan
 
NCT01874548
102-0620A3
No
Gigin Lin, MD, PhD, Chang Gung Memorial Hospital
Chang Gung Memorial Hospital
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Chang Gung Memorial Hospital
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP