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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.
Register: PACTR
Last refreshed on: 29 April 2013
Main ID:  PACTR201211000435126
Date of registration: 15/10/2012
Primary sponsor: Swedish Institute for Infectious Disease Control
Public title: TaMoVaC II
Scientific title: A Phase II trial to assess the safety and immunogenicity of DNA priming
Date of first enrolment: 2012-12-03
Target sample size: 198
Recruitment status: Not yet recruiting
URL:  HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR201211000435126
Study type:  interventional
Study design:  Factorial: participants randomly allocated to either no,one,some or all interventions simultaneously,
Randomised,
Stratified allocation where factors such as age, gender, centre, or previous treatment are used in the stratification (MUHAS 80, MMRP 80, CISPOC 38),
Sealed opaque envelopes.,
 
Countries of recruitment
South Africa
Contacts
Name: Tamer  Barakat
Address:  70th Gomhoria St. 35516 Mansoura Egypt
Telephone: 0020502262222
Email: drtamerbarakat@gmail.com
Affiliation:  Fellow in Urology
Name: Eligius  Lyamuya
Address:  Off United Nations Road 255 Dar es Salaam United Republic of Tanzania
Telephone: +255 (754) 495933
Email: eligius_lyamuya@yahoo.com
Affiliation:  Chief Investigator
Key inclusion & exclusion criteria
Inclusion criteria: Orthotopic substitution
negative ureteral safety margin

Exclusion criteria: incontinent urinary diversion
Short ureters
Technical difficulties


Age minimum: 40 Year
Age maximum: 75 Year
Gender: Both
Health Condition(s) or Problem(s) studied

bladder cancer
Intervention(s)
Primary Outcome(s)
1- Early perioperative complications (including urinary tract infections and urinary leakage) and mortality.
hospital stay
Secondary Outcome(s)
re-admission rate
ureteral stricture
Secondary ID(s)
none
Source(s) of Monetary Support
UNC
Secondary Sponsor(s)
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