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Magnetic Resonance Imaging (MRI) Staging of Cervix Cancer

Prospective Study to Determine the Relationships Between Survival and FIGO Stage, Tumour Volume and Corpus Invasion in Cervical Cancer

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00193934
Enrollment
109
Registered
2005-09-19
Start date
2006-01-31
Completion date
2014-05-15
Last updated
2017-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

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.

Interventions

None listed

Sponsors

Peter MacCallum Cancer Centre, Australia
CollaboratorOTHER
Trans Tasman Radiation Oncology Group
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
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

Countries

Australia, India, New Zealand, Singapore, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026