Collaborative Wilms Tumour Africa Project

• Sponsor: Amsterdam UMC, location VUmc (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT01991652
• Collaborator: (none)
• Enrollment: 400
• Locations: 3
• Anticipated Duration (Months): 131
• Patients Per Site: 133.3
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Wilms Tumour

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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 400 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Collaborative Wilms Tumour Africa Project
• Actual Study Start Date: Jan 1, 2014
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Event free survival [2 years]

   Percentage of patients with no event after two years of follow up.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age < 18 years

• Diagnosis Wilms tumour

Exclusion Criteria:

• None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mbingo Mission Hospital	Bamenda		Cameroon
2	Korle Bu Hospital	Accra		Ghana
3	College of Medicine	Blantyre		Malawi

Sponsors and Collaborators

• Amsterdam UMC, location VUmc

Investigators

• Study Chair: Trijn Israels, MD PhD, Amsterdam UMC, location VUmc

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Trijn Israels, Paediatric Oncologist, MD PhD, Amsterdam UMC, location VUmc
• ClinicalTrials.gov Identifier: NCT01991652
• Other Study ID Numbers: CollabWilmsAfrica
• First Posted: Nov 25, 2013
• Last Update Posted: Jan 3, 2020
• Last Verified: Dec 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Trijn Israels, Paediatric Oncologist, MD PhD, Amsterdam UMC, location VUmc: Wilms tumour; Childhood cancer; Africa
• Additional relevant MeSH terms: Wilms Tumor

Study Results

No Results Posted as of Jan 3, 2020