Magnetic Resonance Imaging (MRI) Staging of Cervix Cancer

NCT00193934 | Completed

• 1 other identifier: TROG 04.02
• Study Type: observational
• Target: 109
• Locations: 5 countries
• Sites: 16

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.

Conditions

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

Outcome Measures

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.

  End of study

Study Arms (1)

1

Cervical Cancer Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Newly diagnosed cervical cancer patients, Female

You may qualify if:

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

You may not qualify if:

• Lymphoma, small cell carcinoma and melanoma histology.
• Previous hysterectomy
• Pregnancy

Sponsors & Collaborators

• Trans Tasman Radiation Oncology Group: lead
• Peter MacCallum Cancer Centre, Australia: collaborator

Study Sites (16)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Liverpool Hospital

Liverpool, New South Wales, 1871, Australia

Location

Calvary Mater Newcastle

Newcastle, New South Wales, 2298, Australia

Location

Royal North Shore Hospital

Sydney, New South Wales, 2069, Australia

Location

Westmead Hospital

Wentworthville, New South Wales, 2145, Australia

Location

Royal Brisbane Hospital

Herston, Queensland, 4029, Australia

Location

North Queensland Oncology Service

Townsville, Queensland, 4810, Australia

Location

Premion - Tugun

Tugun, Queensland, 4224, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3002, Australia

Location

Tata Memorial Hospital

Mumbai, India

Location

Meenakshi Mission Hospital

Tamil Nadu, India

Location

Auckland Hospital

Auckland, 1001, New Zealand

Location

Christchurch Hospital

Christchurch, 4710, New Zealand

Location

Dunedin Hospital

Dunedin, New Zealand

Location

National University Hospital

Singapore, Singapore

Location

Related Publications (3)

• 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.

  PMID: 14528092 BACKGROUND

• 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.

  PMID: 14675351 BACKGROUND

• 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.

  PMID: 16014109 BACKGROUND

Related Links

• Click here for more information about this study on the TROG official website

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gerard Adams

  Oceania Oncology

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Rebecca Montgomery

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 19, 2005
• Study Start: January 1, 2006
• Primary Completion: May 1, 2014
• Study Completion: May 15, 2014
• Last Updated: July 12, 2017

Record last verified: 2017-07

Locations

SG (1); AU (9); IN (2); US (1); NZ (3)