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MR Metabolic Biomarkers for Cervical Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01874548
First Posted: June 11, 2013
Last Update Posted: August 15, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Gigin Lin, Chang Gung Memorial Hospital
  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.

Condition
Uterine Cervical Neoplasms

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Magnetic Resonance Study on Metabolism Biomarkers for Cervical Cancer.

Resource links provided by NLM:


Further study details as provided by Gigin Lin, 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 ]

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.

Enrollment: 136
Study Start Date: July 2013
Study Completion Date: June 2016
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Normal cervix
Control group (n=30) comprising surgical candidates with normal cervical tissue will be collected for comparison.
Cervical cancer
  1. 1st year: 30 surgical candidates with cervical cancer tissue collected during operation.
  2. 2nd year: 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.
  3. 3rd year: enroll 60 patients primarily treated with CCRT and collect the data using clinical MR and tissue high resolution MRS.

Detailed Description:

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.

  Eligibility

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01874548


Locations
Taiwan
Department of Radiology, Chang Gung Memorial Hospital
Guishan, Taoyuan, Taiwan, 333
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Principal Investigator: Gigin Lin, MD, PhD Department of Medical Imaging and Intervention, Chang Gung Memorial Hospital
  More Information

Additional Information:
Publications:
Study Data/Documents: Clinical Study Report  This link exits the ClinicalTrials.gov site

Responsible Party: Gigin Lin, Department of Radiology, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01874548     History of Changes
Other Study ID Numbers: 102-0620A3
First Submitted: June 6, 2013
First Posted: June 11, 2013
Last Update Posted: August 15, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Gigin Lin, 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