Collaborative Wilms Tumour Africa Project

NCT ID: NCT01991652

Last Updated: 2020-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Wilms Tumour

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Age \< 18 years
* Diagnosis Wilms tumour

Exclusion Criteria

\* None
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amsterdam UMC, location VUmc

OTHER

Sponsor Role lead

Responsible Party

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Trijn Israels

Paediatric Oncologist, MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Trijn Israels, MD PhD

Role: STUDY_CHAIR

Amsterdam UMC, location VUmc

Locations

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Mbingo Mission Hospital

Bamenda, , Cameroon

Site Status RECRUITING

Korle Bu Hospital

Accra, , Ghana

Site Status RECRUITING

College of Medicine

Blantyre, , Malawi

Site Status RECRUITING

Countries

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Cameroon Ghana Malawi

Central Contacts

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Trijn Israels, MD PhD

Role: CONTACT

+31.6.42717920

Elizabeth Molyneux, Prof

Role: CONTACT

Facility Contacts

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Peter Hesseling

Role: primary

Lorna Renner, MD

Role: primary

Elizabeth Molyneux, Prof

Role: primary

Neil Kennedy, Prof

Role: backup

References

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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.

Reference Type RESULT
PMID: 23015404 (View on PubMed)

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.

Reference Type RESULT
PMID: 23441092 (View on PubMed)

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.

Reference Type RESULT
PMID: 23897077 (View on PubMed)

Other Identifiers

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CollabWilmsAfrica

Identifier Type: -

Identifier Source: org_study_id

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