NCT01874548

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 11, 2013

Completed
20 days until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

August 15, 2016

Status Verified

August 1, 2016

Enrollment Period

2.9 years

First QC Date

June 6, 2013

Last Update Submit

August 12, 2016

Conditions

Uterine Cervical Neoplasms

Keywords

AutophagyCancer metabolismCervical cancerDiffusion weighted imagingHuman papillomavirusMagnetic resonance spectroscopy.

Outcome Measures

Primary Outcomes (1)

  • the amounts of metabolites in uterine cervical tissue

    up to 8 weeks of magnetic resonance imaging and spectroscopy exam

Study Arms (2)

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.

Eligibility Criteria

Age20 Years - 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients in a tertiary referral center.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Radiology, Chang Gung Memorial Hospital

Guishan, Taoyuan, 333, Taiwan

Location

Related Publications (1)

  • Lin G, Lai CH, Tsai SY, Lin YC, Huang YT, Wu RC, Yang LY, Lu HY, Chao A, Wang CC, Ng KK, Ng SH, Chou HH, Yen TC, Hung JH. 1 H MR spectroscopy in cervical carcinoma using external phase array body coil at 3.0 Tesla: Prediction of poor prognostic human papillomavirus genotypes. J Magn Reson Imaging. 2017 Mar;45(3):899-907. doi: 10.1002/jmri.25386. Epub 2016 Jul 19.

    PMID: 27434095BACKGROUND

Related Links

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.

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Gigin Lin, MD, PhD

    Department of Medical Imaging and Intervention, Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Radiology

Study Record Dates

First Submitted

June 6, 2013

First Posted

June 11, 2013

Study Start

July 1, 2013

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

August 15, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)