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
  Purpose

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.


Condition
Uterine Cervical Neoplasms

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 120
Study Start Date: July 2013
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Normal cervix
Cervical cancer

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients in a tertiary referral center.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01874548

Contacts
Contact: Gigin Lin, MD, PhD 886-3281200 ext 2575 giginlin@cgmh.org.tw

Locations
Taiwan
Department of Radiology, Chang Gung Memorial Hospital Recruiting
Guishan, Taoyuan, Taiwan, 333
Contact: Gigin Lin, MD, PhD    886-3-3281200 ext 2575    giginlin@cgmh.org.tw   
Sponsors and Collaborators
Chang Gung Memorial Hospital
  More Information

No publications provided

Responsible Party: Gigin Lin, MD, PhD, Department of Radiology, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01874548     History of Changes
Other Study ID Numbers: 102-0620A3
Study First Received: June 6, 2013
Last Updated: July 5, 2013
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Chang Gung Memorial Hospital:
Autophagy
Cancer metabolism
Cervical cancer
Diffusion weighted imaging
Human papillomavirus
Magnetic resonance spectroscopy.

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on September 30, 2014