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Main
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Note: This record shows only 22 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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12 December 2020 |
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Main ID: |
NCT01248637 |
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Date of registration:
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24/11/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Study of Intratumoral Hypoxia Using Pre-operative Administration of Pimonidazole
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Scientific title:
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A Clinical Trial of Intratumoral Hypoxia and Its Biologic Correlates in Patients Undergoing Surgical Resection of Localized Pancreatic Cancer, Using Pre-operative Administration of the Hypoxia Marker Pimonidazole. |
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Date of first enrolment:
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October 2010 |
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Target sample size:
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200 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01248637 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Canada
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Contacts
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Name:
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Neesha Dhani, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Univeristy Health Network - Princess Margaret Cancer Centre |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- age > 18
- provisional diagnosis of pancreatic cancer
- scheduled resection at UHN
- consented to ICGC Pancreatic Cancer Genome Project
- surgery planned for >2 days away (drug administration has to be 16-20hrs before
surgery)
Exclusion Criteria:
- not participating in ICGC
- contraindications to pimonidazole (allergy)
- surgery scheduled for same or next day (not enough time to arrange for drug
administration)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Pancreatic Cancer
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Intervention(s)
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Drug: Pimonidazole hydrochloride
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Primary Outcome(s)
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characterization of intratumoral hypoxia in pancreatic cancer
[Time Frame: 5 Years]
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correlation of intratumoral hypoxia with patient survival rate
[Time Frame: 5 Years]
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Secondary Outcome(s)
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correlation of hypoxia with molecular markers
[Time Frame: 5 Years]
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to assess utility of circulating osteopontin and miR-210 for identifying hypoxia
[Time Frame: 5 Years]
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Secondary ID(s)
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UHN REB 10-0350-C
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PIMO-PANC
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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