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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00193934
Registration number
NCT00193934
Ethics application status
Date submitted
12/09/2005
Date registered
19/09/2005
Date last updated
12/07/2017
Titles & IDs
Public title
Magnetic Resonance Imaging (MRI) Staging of Cervix Cancer
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Scientific title
Prospective Study to Determine the Relationships Between Survival and FIGO Stage, Tumour Volume and Corpus Invasion in Cervical Cancer
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Secondary ID [1]
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TROG 04.02
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cancer of the Uterine Cervix
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Condition category
Condition code
Cancer
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Womb (Uterine or endometrial cancer)
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Cancer
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Cervical (cervix)
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
1 - Cervical Cancer Patients
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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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.
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Assessment method [1]
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Timepoint [1]
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End of study
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Lymphoma, small cell carcinoma and melanoma histology.
2. Previous hysterectomy
3. Pregnancy
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2006
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
15/05/2014
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Sample size
Target
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Accrual to date
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Final
109
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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Liverpool Hospital - Liverpool
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Recruitment hospital [2]
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Calvary Mater Newcastle - Newcastle
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Recruitment hospital [3]
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Royal North Shore Hospital - Sydney
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Recruitment hospital [4]
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Westmead Hospital - Wentworthville
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Recruitment hospital [5]
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Royal Brisbane Hospital - Herston
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Recruitment hospital [6]
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North Queensland Oncology Service - Townsville
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Recruitment hospital [7]
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Premion - Tugun - Tugun
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Recruitment hospital [8]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [9]
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Peter MacCallum Cancer Centre - Melbourne
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Recruitment postcode(s) [1]
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1871 - Liverpool
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Recruitment postcode(s) [2]
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2298 - Newcastle
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Recruitment postcode(s) [3]
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2069 - Sydney
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Recruitment postcode(s) [4]
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2145 - Wentworthville
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Recruitment postcode(s) [5]
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4029 - Herston
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Recruitment postcode(s) [6]
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4810 - Townsville
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Recruitment postcode(s) [7]
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4224 - Tugun
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Recruitment postcode(s) [8]
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5000 - Adelaide
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Recruitment postcode(s) [9]
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3002 - Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Missouri
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Country [2]
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India
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State/province [2]
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Mumbai
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India
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State/province [3]
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Tamil Nadu
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New Zealand
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State/province [4]
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Auckland
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Country [5]
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New Zealand
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State/province [5]
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Christchurch
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Country [6]
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New Zealand
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State/province [6]
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Dunedin
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Country [7]
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Singapore
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State/province [7]
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Singapore
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Funding & Sponsors
Primary sponsor type
Other
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Name
Trans Tasman Radiation Oncology Group
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Address
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Other collaborator category [1]
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Other
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Name [1]
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Peter MacCallum Cancer Centre, Australia
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT00193934
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Trial related presentations / 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. 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. 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.
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Public notes
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Contacts
Principal investigator
Name
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Gerard Adams
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Address
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Oceania Oncology
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT00193934
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