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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01226264 |
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Date of registration:
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21/10/2010 |
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Primary sponsor: |
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Public title:
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Diffusion MRI; Predictive Value for Cervical Uterine Cancer Recurrence
s52647 |
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Scientific title:
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Diffusion MRI; Predictive Value for Cervical Uterine Cancer Recurrence. |
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Date of first enrolment:
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November 2010 |
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Target sample size:
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40 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01226264 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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Countries of recruitment
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Belgium
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Contacts
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Name:
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Ilse Roebben, Master in Biomedical Sciences |
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Address:
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Telephone:
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+32 16 34 90 74 |
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Email:
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ilse.roebben@uzleuven.be |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients diagnosed with cervical uterine cancer are, on a voluntary basis, enrolled
in the study. These are patients who either underwent curative chemoradiation (mainly
patients with advanced stage cancer) or neoadjuvant chemotherapy (predominantly in
patients with early stage cancer) before undergoing surgery.
Exclusion Criteria:
- Patients with known contra-indications for MRI (cardiac pacemakers, cochlear
implants, claustrophobic patients) will be excluded from this study. And so are
patients with contra-indications to Gadolinium-based contrast agents and patients
with a known restricted renal function (GFR < 30 ml/min).
Age minimum:
N/A
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Diffusion-weighted MRI
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Recurrence
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Uterine Cervical Cancer
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Intervention(s)
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Procedure: Diffusion weighted MRI (DW- MRI)
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Primary Outcome(s)
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Evaluation of the predictive value of DWI during and after therapy in the prediction of recurrence of cervical uterine cancer.
[Time Frame: 2010-2014 continuously]
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Secondary Outcome(s)
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Reduction in toxicity related to the treatment
[Time Frame: 2010-2014]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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