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Collaborative Wilms Tumour Africa Project

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2016 by VU University Medical Center
Sponsor:
Information provided by (Responsible Party):
Trijn Israels, VU University Medical Center
ClinicalTrials.gov Identifier:
NCT01991652
First received: November 12, 2013
Last updated: November 14, 2016
Last verified: November 2016
  Purpose

Significant progress has been made in the treatment of Wilms tumor in high income countries, where survival is now around 85% - 90%. Survival in low income countries is much lower; specific challenges include late presentation, malnutrition, less intense supportive care facilities and failure to complete treatment.

A comprehensive treatment guideline was introduced in Malawi in 2006 which included nutritional support and social support to enable parents to complete treatment. Survival has increased to around 50%; 95% of children completed their treatment. A multi-disciplinary group of African clinicians and 'state of the art' experts produced a consensus treatment guideline for children with Wilms tumor in sub-Saharan Africa. This guideline will be implemented as a multi-center prospective clinical trial in 2014 in six - eight institutes, expecting about 200 new patients per year.

The hypothesis is that 2 year event free survival will be 50%, with <10% failure to complete treatment and <10% treatment related mortality. Other research questions include efficacy and toxicity of preoperative chemotherapy and the comparison of surgical staging, local pathology and central review pathology in stratifying postoperative chemotherapy.


Condition Phase
Wilms Tumour
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Collaborative Wilms Tumour Africa Project

Resource links provided by NLM:


Further study details as provided by VU University Medical Center:

Primary Outcome Measures:
  • Event free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: January 2014
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Wilms tumour

Children diagnosed with a Wilms tumour receive SIOP PODC Wilms tumour treatment; preoperative chemotherapy, surgery and postoperative chemotherapy (= standard care).

One group of patients.


Detailed Description:
Patients are treated according to standard care. Data are documented on presentation at diagnosis, response of the tumor, findings at surgery and pathology, treatment given and outcome of the patients.
  Eligibility

Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Children (< 18 years) diagnosed with a Willms tumour
Criteria

Inclusion Criteria:

  • Age < 18 years
  • Diagnosis Wilms tumour

Exclusion Criteria:

* None

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01991652

Contacts
Contact: Trijn Israels, MD PhD +31.6.42717920 t.israels@vumc.nl
Contact: Elizabeth Molyneux, Prof emmolyneux@gmail.com

Locations
Cameroon
Mbingo Mission Hospital Recruiting
North West Cameroon, Cameroon
Contact: Peter Hesseling       pbh@sun.ac.za   
Principal Investigator: Francine Kouya, MD         
Ethiopia
Tikur Anbessa Specialized Hospital Recruiting
Addis Abeba, Ethiopia
Contact: Haileyesus David, MD       biruhraey@gmail.com   
Principal Investigator: Yasar Celiker, MD         
Ghana
Korle Bu Hospital Recruiting
Accra, Ghana
Contact: Lorna Renner, MD       lornarenner@gmail.com   
Principal Investigator: Lorna Renner, MD         
Malawi
College of Medicine Recruiting
Blantyre, Malawi
Contact: Elizabeth Molyneux, Prof       emmolyneux@gmail.com   
Contact: Neil Kennedy, Prof       n.kennedy@medcol.mw   
Principal Investigator: Elizabeth Molyneux, Prof         
Sponsors and Collaborators
VU University Medical Center
Investigators
Study Chair: Trijn Israels, MD PhD VU University Medical Center
  More Information

Publications:
Responsible Party: Trijn Israels, Paediatric Oncologist, MD PhD, VU University Medical Center
ClinicalTrials.gov Identifier: NCT01991652     History of Changes
Other Study ID Numbers: CollabWilmsAfrica 
Study First Received: November 12, 2013
Last Updated: November 14, 2016
Health Authority: Malawi: College of Medicine Research and Ethics Committee
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by VU University Medical Center:
Wilms tumour
Childhood cancer
Africa

Additional relevant MeSH terms:
Wilms Tumor
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Neoplasms
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplastic Syndromes, Hereditary
Kidney Diseases
Urologic Diseases
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on December 09, 2016