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CompletedNCT00193934Updated Jul 12, 2017

Magnetic Resonance Imaging (MRI) Staging of Cervix Cancer

An observational study in Cancer of the Uterine Cervix, sponsored by Trans Tasman Radiation Oncology Group. Completed at 16 sites in 5 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-07-12.

Sponsored by Trans Tasman Radiation Oncology Group · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
109
Ages
18 Years and older
Sex
Female
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Study summary

The researchers propose that it may be corpus invasion, rather than tumour volume per se, which is one of the important determinants of ultimate outcome in cervix cancer. The aim of the proposed prospective, multicentre study, is to confirm the results of our retrospective studies, specifically that corpus invasion or tumour volume or both contribute important prognostic information over and above that provided by the currently used International Federation of Gynecology and Obstetrics (FIGO) staging system. A successful outcome would have important implications for the staging, and management as well as the biologic understanding of the behaviour of cervical cancer.

Read the detailed description

This will be a prospective, multicentre, prognostic factor, follow-up study. The study is designed to be as simple as possible: newly diagnosed cervical cancer patients will have key prognostic variables collected at baseline. The treatment received will be documented at the end of treatment and patients will then be followed for first relapse and survival.

Registration of a patient on this study can be undertaken after EUA, biopsy confirmed diagnosis, anatomic staging diagram and MRI have been done and before any treatment has commenced.

Treatment must be curative in intent (termed radical therapy) but otherwise can be at the discretion of the investigator. Radical hysterectomy alone, hysterectomy followed by adjuvant radiotherapy, radical chemo-radiotherapy or radical radiotherapy will be allowed. Details of the planned and given treatment regimen will be recorded.

All patients will have the following trial data documented at the time of registration:

  • Age
  • ECOG performance status
  • smoking status
  • date of histological diagnosis
  • histologic type and features
  • presenting haemoglobin
  • standard FIGO staging
  • maximum clinical tumour diameter measured at EUA
  • detailed staging diagram drawn at EUA
  • nodal status (by surgical pathology or CT or MRI or both and PET if available)
  • date of MRI
  • MRI tumour diameters
  • presence or absence of corpus invasion on MRI
  • planned treatment details

All patients will be assessed pre-treatment, immediately following treatment and will be followed up for local control and survival at yearly intervals from the date of registration.

It is intended to collect follow up information on all patients until one year after the final patient is registered on study.

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Conditions studied

  • Cancer of the Uterine Cervix

Keywords

  • Women's Health
  • Multidisciplinary, multicentre prospective study
  • Cancer:mechanisms of growth, invasion, metastases
  • Figo Stages cervical cancer
  • Advances in diagnosis using radiological methods
  • Quantitative Magnetic Resonance Imaging
  • Patient Management Strategies
  • Selecting patients for therapy
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In context

Uterine Cervical Neoplasms

1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.

This study's enrollment of 109 is below the median of 220 across 419 observational studies indexed under Uterine Cervical Neoplasms.

Browse Uterine Cervical Neoplasms studies →

Lead sponsor

Trans Tasman Radiation Oncology Group is the lead sponsor of 34 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Newly diagnosed cervical cancer patients, Female

Inclusion criteria

  1. Newly diagnosed, biopsy proven carcinoma of the uterine cervix.
  2. Squamous cell, adenocarcinoma, adenosquamous or large cell carcinoma histology.
  3. FIGO Stage Ib -IVa.
  4. Maximum clinical tumour diameter recorded.
  5. MRI done within 30 days prior to registration.
  6. Intention to treat radically
  7. Treatment not yet started.
  8. Written informed consent.
  9. Available for follow-up.

Exclusion criteria

Exclusion Criteria:

  1. Lymphoma, small cell carcinoma and melanoma histology.
  2. Previous hysterectomy
  3. Pregnancy
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
109 participants (actual)

Groups and cohorts

  • 1

    Cervical Cancer Patients

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What researchers measure

Primary outcomes

  1. Assess the prognostic significance, with respect to overall survival, of the factors, FIGO stage. Overall survival is defined as the date of registration to date of death from any cause.

    Time frame: End of study

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Study locations

16 sites
  • Washington University School of Medicine
    Saint Louis, Missouri 63110, United States
  • Liverpool Hospital
    Liverpool, New South Wales 1871, Australia
  • Calvary Mater Newcastle
    Newcastle, New South Wales 2298, Australia
  • Royal North Shore Hospital
    Sydney, New South Wales 2069, Australia
  • Westmead Hospital
    Wentworthville, New South Wales 2145, Australia
  • Royal Brisbane Hospital
    Herston, Queensland 4029, Australia
  • North Queensland Oncology Service
    Townsville, Queensland 4810, Australia
  • Premion - Tugun
    Tugun, Queensland 4224, Australia
  • Royal Adelaide Hospital
    Adelaide, South Australia 5000, Australia
  • Peter MacCallum Cancer Centre
    Melbourne, Victoria 3002, Australia
  • Tata Memorial Hospital
    Mumbai, India
  • Meenakshi Mission Hospital
    Tamil Nadu, India
  • Auckland Hospital
    Auckland, 1001, New Zealand
  • Christchurch Hospital
    Christchurch, 4710, New Zealand
  • Dunedin Hospital
    Dunedin, New Zealand
  • National University Hospital
    Singapore, Singapore
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References and documents

Publications

  • Narayan K, McKenzie A, Fisher R, Susil B, Jobling T, Bernshaw D. Estimation of tumor volume in cervical cancer by magnetic resonance imaging. Am J Clin Oncol. 2003 Oct;26(5):e163-8. doi: 10.1097/01.coc.0000091358.78047.b5. PubMed 14528092 ↗
  • Narayan K, McKenzie AF, Hicks RJ, Fisher R, Bernshaw D, Bau S. Relation between FIGO stage, primary tumor volume, and presence of lymph node metastases in cervical cancer patients referred for radiotherapy. Int J Gynecol Cancer. 2003 Sep-Oct;13(5):657-63. doi: 10.1046/j.1525-1438.2003.13026.x. PubMed 14675351 ↗
  • Narayan K. Arguments for a magnetic resonance imaging-assisted FIGO staging system for cervical cancer. Int J Gynecol Cancer. 2005 Jul-Aug;15(4):573-82. doi: 10.1111/j.1525-1438.2005.00128.x. PubMed 16014109 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 12, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00193934
Lead sponsor
Trans Tasman Radiation Oncology Group
Collaborators
Peter MacCallum Cancer Centre, Australia
Responsible party
TROG Administrator (Rebecca Montgomery, Trans Tasman Radiation Oncology Group) — Principal investigator
First posted
Sep 19, 2005
Start date
Jan 2006
Primary completion
May 2014
Completion
May 15, 2014
Last update
Jul 12, 2017

Study contacts

Gerard Adams
study chair · Oceania Oncology

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.

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