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Magnetic Resonance Imaging (MRI) Staging of Cervix Cancer

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. Identifier: NCT00193934
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : July 12, 2017
Peter MacCallum Cancer Centre, Australia
Information provided by (Responsible Party):
TROG Administrator, Trans Tasman Radiation Oncology Group

Brief 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.

Condition or disease
Cancer of the Uterine Cervix

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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Study Type : Observational
Actual Enrollment : 109 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Study to Determine the Relationships Between Survival and FIGO Stage, Tumour Volume and Corpus Invasion in Cervical Cancer
Study Start Date : January 2006
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 15, 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Cervical Cancer Patients

Primary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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:

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

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 identifier (NCT number): NCT00193934

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United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Australia, New South Wales
Liverpool Hospital
Liverpool, New South Wales, Australia, 1871
Calvary Mater Newcastle
Newcastle, New South Wales, Australia, 2298
Royal North Shore Hospital
Sydney, New South Wales, Australia, 2069
Westmead Hospital
Wentworthville, New South Wales, Australia, 2145
Australia, Queensland
Royal Brisbane Hospital
Herston, Queensland, Australia, 4029
North Queensland Oncology Service
Townsville, Queensland, Australia, 4810
Premion - Tugun
Tugun, Queensland, Australia, 4224
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 3002
Tata Memorial Hospital
Mumbai, India
Meenakshi Mission Hospital
Tamil Nadu, India
New Zealand
Auckland Hospital
Auckland, New Zealand, 1001
Christchurch Hospital
Christchurch, New Zealand, 4710
Dunedin Hospital
Dunedin, New Zealand
National University Hospital
Singapore, Singapore
Sponsors and Collaborators
Trans Tasman Radiation Oncology Group
Peter MacCallum Cancer Centre, Australia
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Study Chair: Gerard Adams Oceania Oncology
Additional Information:
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Responsible Party: TROG Administrator, Rebecca Montgomery, Trans Tasman Radiation Oncology Group Identifier: NCT00193934    
Other Study ID Numbers: TROG 04.02
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: July 12, 2017
Last Verified: July 2017
Keywords provided by TROG Administrator, Trans Tasman Radiation Oncology Group:
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
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases