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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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CTRI |
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Last refreshed on:
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24 November 2021 |
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Main ID: |
CTRI/2016/07/007124 |
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Date of registration:
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29-07-2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Survey study of patient related outcomes (items) to be used in pancreatic cancer care and research.
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Scientific title:
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â??Developing a COre-set of Patient-Reported outcomes in pAncreatic Cancer (COPRAC):an international Delphi surveyâ?? - COPRAC |
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Date of first enrolment:
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15-08-2016 |
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Target sample size:
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560 |
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Recruitment status: |
Not Yet Recruiting |
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URL:
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http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=15650 |
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Study type:
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Observational |
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Study design:
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Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
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Phase:
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N/A
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Countries of recruitment
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India
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Italy
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Netherlands
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Other
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United States of America
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Contacts
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Name:
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Shailesh Vinayak Shrikhande
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Address:
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12th Floor 1222 Homibhaba building Tata Memorial Hospital Dr Ernest Borges Marg parel Mumbai
400012
Bangalore, MAHARASHTRA
India |
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Telephone:
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9820224761 |
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Email:
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shailushrikhande@hotmail.com |
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Affiliation:
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Tata Memorial Hospital |
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Name:
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Shailesh Vinayak Shrikhande
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Address:
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12th Floor 1222 Homibhaba building Tata Memorial Hospital Dr Ernest Borges Marg parel Mumbai
400012
Krishna, MAHARASHTRA
India |
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Telephone:
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9820224761 |
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Email:
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shailushrikhande@hotmail.com |
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Affiliation:
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Tata Memorial Hospital |
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Key inclusion & exclusion criteria
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Inclusion criteria: Patients with histo- or cytopathologically proven pancreatic or periampullary cancer diagnosed between January 2012 and July 2015 in the Johns Hopkins Hospital, Baltimore, the Massachusetts General Hospital, Boston, the Beth Israel Deaconess Medical Center, Boston (all USA),the University of Verona Hospital Trust, Verona, Italy, the Dutch Pancreatic Cancer Group (DPCG), Tata Memorial Centre, Mumbai, India and the Seoul National University Hospital, Seoul, South Korea will be identified and will receive an electronic invitation to participate in the survey
Exclusion criteria: Patients with a life expectancy of less than three months are excluded to ensure completion of both rounds
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Health Condition 1: null- Pancreas or periampullary
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Primary Outcome(s)
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The objective of this study is to internationally validate a core set of PROs to be used in pancreatic cancer care and research.
â??
Timepoint: 1 year
â??
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Secondary Outcome(s)
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Patient related outcomesTimepoint: 1 year
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Secondary ID(s)
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1717 Protocol version 4 dated 29.06.2015
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Source(s) of Monetary Support
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Intramural Funding
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Ethics review
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Status: Approved
Approval date: 01/07/2016
Contact:
Institutional Ethics Committee
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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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