Wilms TumourNCT01991652
Collaborative Wilms Tumour Africa Project
An observational study of Wilms Tumour, run by Amsterdam UMC, location VUmc at 3 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Wilms Tumour
- How many people
- 400 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Jan 2014to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children (< 18 years) diagnosed with a Willms tumour
Who may be able to join
- Age < 18 years
- Diagnosis Wilms tumour
Who cannot join
- None
Trial locations and contacts
3 sites in 3 countries.
Elizabeth Molyneux, Prof contact
3 sites in 3 countries
Cameroon1 site, 1 recruiting
- Recruiting
Mbingo Mission Hospital
Bamenda
Peter Hesseling, pbh@sun.ac.za
Francine Kouya, MD
Ghana1 site, 1 recruiting
- Recruiting
Korle Bu Hospital
Accra
Lorna Renner, MD, lornarenner@gmail.com
Lorna Renner, MD
Malawi1 site, 1 recruiting
- Recruiting
College of Medicine
Blantyre
Elizabeth Molyneux, Prof, emmolyneux@gmail.com
Neil Kennedy, Prof, n.kennedy@medcol.mw
About this study
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.
Read the 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.
- Conditions
- Wilms Tumour
- Keywords
- Wilms tumour, Childhood cancer, Africa
- Medical subject headings
- Wilms Tumor, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event free survival
Percentage of patients with no event after two years of follow up.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startJan 2014
- Primary completionDec 2022 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Wilms TumourStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Trijn Israels, Amsterdam UMC, location VUmc
- Investigators
- Trijn Israels, MD PhD, Study chair, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01991652
- Sponsor's protocol ID
- CollabWilmsAfrica
- Status last verified
- Dec 2019
- First submitted
- 12 Nov 2013
- Last updated
- 3 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 23015404Israels 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.
PubMed 23441092Israels 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.
PubMed 23897077
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collaborative Wilms Tumour Africa Project
- ClinicalTrials.gov ID
- NCT01991652
- Acronym / sponsor ID
- CollabWilmsAfrica
- Conditions
- Wilms Tumour
- Keywords
- Wilms tumour, Childhood cancer, Africa
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 25 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children (< 18 years) diagnosed with a Willms tumour
Key inclusion criteria (2 listed)
- Age < 18 years
- Diagnosis Wilms tumour
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Event free survival
Time frame: 2 years
Percentage of patients with no event after two years of follow up.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2020.
- Results publication: PubMed 23015404Israels 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.
- Results publication: PubMed 23441092Israels 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.
- Results publication: PubMed 23897077Israels 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Molyneux, Prof contact
Trijn Israels, MD PhD study chair
Amsterdam UMC, location VUmc
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wilms Tumour, run by Amsterdam UMC, location VUmc at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Cameroon, Ghana, Malawi. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Trijn Israels, MD PhD (+31.6.42717920, t.israels@vumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event free survival (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01991652, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2020.