Collaborative Wilms Tumour Africa Project

NCT01991652 | Unknown DMC

• 1 other identifier: CollabWilmsAfrica
• Study Type: observational
• Target: 400
• Locations: 3 countries
• Sites: 3

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.

Conditions

Wilms Tumour

Keywords

Wilms tumour; Childhood cancer; Africa

Outcome Measures

Primary Outcomes (1)

• Event free survival

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

  2 years

Study Arms (1)

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.

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Children (\< 18 years) diagnosed with a Willms tumour

You may qualify if:

• Age \< 18 years
• Diagnosis Wilms tumour

You may not qualify if:

• \* None

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead

Study Sites (3)

Mbingo Mission Hospital

Bamenda, Cameroon

RECRUITING

Korle Bu Hospital

Accra, Ghana

RECRUITING

College of Medicine

Blantyre, Malawi

RECRUITING

Related Publications (3)

• Israels T, Moreira C, Scanlan T, Molyneux L, Kampondeni S, Hesseling P, Heij H, Borgstein E, Vujanic G, Pritchard-Jones K, Hadley L. SIOP PODC: clinical guidelines for the management of children with Wilms tumour in a low income setting. Pediatr Blood Cancer. 2013 Jan;60(1):5-11. doi: 10.1002/pbc.24321. Epub 2012 Sep 26.

  PMID: 23015404 RESULT

• Israels T, Renner L, Hendricks M, Hesseling P, Howard S, Molyneux E; Paediatric Oncology in Developing Countries. SIOP PODC: recommendations for supportive care of children with cancer in a low-income setting. Pediatr Blood Cancer. 2013 Jun;60(6):899-904. doi: 10.1002/pbc.24501. Epub 2013 Feb 25.

  PMID: 23441092 RESULT

• Israels T, Kambugu J, Kouya F, El-Mallawany NK, Hesseling PB, Kaspers GJ, Eden T, Renner L, Molyneux EM. Clinical trials to improve childhood cancer care and survival in sub-Saharan Africa. Nat Rev Clin Oncol. 2013 Oct;10(10):599-604. doi: 10.1038/nrclinonc.2013.137. Epub 2013 Jul 30.

  PMID: 23897077 RESULT

MeSH Terms

Conditions

Wilms Tumor; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Complex and Mixed; Neoplasms by Histologic Type; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplastic Syndromes, Hereditary; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Trijn Israels, MD PhD

  Amsterdam UMC, location VUmc

  STUDY CHAIR

Central Study Contacts

Trijn Israels, MD PhD

CONTACT

+31.6.42717920; t.israels@vumc.nl

Elizabeth Molyneux, Prof

CONTACT

emmolyneux@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Paediatric Oncologist, MD PhD

Study Record Dates

• First Submitted: November 12, 2013
• First Posted: November 25, 2013
• Study Start: January 1, 2014
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2024
• Last Updated: January 3, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); GH (1); MA (1)