Kidney CancerUMBRELLANCT04005820
Impact of Tumour 1q Gain in French Pediatric and Young Adult Patients With Renal Tumours
A study testing Radiologic Centralized Review and Tissue sample (tumor, sung, urine) in people with Kidney Cancer, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
French patients with nephroblastoma (Wilms tumour, WT) have been treated for > 40 years according to International Society of Paediatric Oncology (SIOP) protocols with currently 267 centres across 28 countries collaborating internationally within the SIOP Renal Tumour Study Group (RTSG). Read more about this study
- Who is it for?
- Ages Up to 30 years
- Conditions the study is for
- Kidney Cancer
- What is being tested?
- Radiologic Centralized Review and Tissue sample (tumor, sung, urine)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 510 participants
- Where
- 1 siteFrance
- Study dates
- 1 Aug 2019to 1 Aug 2026
- Phase
- Interventional
- 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 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children, adolescents or young adults (up to and including 30 years) with primary or relapsed renal tumor diagnosed at a participating SIOP-RTSG center
- Subject agreeing to participate
Who cannot join
- Absence of informed consent
Trial locations and contacts
1 site in 1 country.
France1 site
Service d'Hématologie-Oncologie Pédiatrique - APHM
Marseille, 13354
Arnauld VERSCHUUR, 33(0)4 91 38 84 78, arnauld.verschuur@ap-hm.fr
About this study
Official title: Treatment for French Pediatric Patients With Renal Tumours According to the International SIOP Renal Tumour Study Group (RTSG) 2016 UMBRELLA Protocol Including Analysis of Tumour Chromosome 1q Gain and Central Radiology Review
French patients with nephroblastoma (Wilms tumour, WT) have been treated for > 40 years according to International Society of Paediatric Oncology (SIOP) protocols with currently 267 centres across 28 countries collaborating internationally within the SIOP Renal Tumour Study Group (RTSG).
Over the last decades more than 10,000 children have been prospectively enrolled in SIOP WT studies and trials. This has resulted in more standardised diagnostic procedures, improved risk stratification, and adjusted treatment recommendations for most renal tumours. The treatment of patients with renal tumours according to SIOP protocols include preoperative chemotherapy, surgery (tumour-nephrectomy + node-picking ± metastasectomy) followed by risk- and stage-based postoperative chemotherapy ± radiotherapy. Central pathology review is nowadays routinely performed in order to prevent misclassification of stage and histology risk group.
Read more
The current SIOP 2001 protocol has come to an end with as major achievement the scientific proof of omitting doxorubicin in stage II and III patients with as a consequence less risk of sequelae. Moreover, in the SIOP 2001 protocol, several tumour biological aspects have been assessed that seem to interfere with outcome (chromosomal gain of 1q, or loss of 1p and 16q, blastemal residual volume). Chromosomal 1q gain is considered to be present in 25-35% of patients with nephroblastoma with a negative impact on event-free survival (EFS) in retrospective analyses. These biological aspects will be studied prospectively as a primary objective in the new SIOP RTSG 2016 UMBRELLA protocol that integrates diagnostics, treatment and follow-up guidelines as well as several research projects.
The main mission of the International Society of Paediatric Oncology (SIOP) Renal Tumour Study Group (RTSG) is to increase survival and to reduce acute treatment toxicity and late effects in all children diagnosed with any renal tumour. In this context, SIOP RTSG is aiming to offer all these patients the same standardized high quality diagnostics and treatment, independent of the tumour type. The new SIOP RTSG 2016 integrated diagnostic and research UMBRELLA protocol serves as an entry for including all children with a renal tumour in the SIOP-RTSG centers, including prospective biomarker analyses. Subsequently, treatment is recommended according to the SIOP RTSG 2016 UMBRELLA treatment guidelines, which provides treatment strategies for all patients with Wilms tumour (WT) and other renal tumours. Central radiology review (CRR) has been proposed as a novel tool within the diagnostic UMBRELLA protocol in order to optimize the diagnostics and hence the treatment.
The definition of metastatic disease in WT remains difficult since pulmonary nodules may not always be of malignant origin. The differential diagnosis of a pulmonary lesion seen in a child with WT is broad. In addition to malignancy, it includes atelectasis, fibrosis, pneumonitis, subpleural lymph nodes, and other infectious or inflammatory lesions. In addition, the issue of "CT-only" nodules in WT and adequate treatment needs to be solved. In previous protocols, the treatment strategy was based on the diagnosis of pulmonary metastases (92% of all metastases) by conventional pulmonary X-ray. Patients with CT-only nodules (= nodules not visible on conventional X-ray) were supposed to be treated as having localized WT. However, retrospective analyses of SIOP series (Smets et al), showed that patients with CT-only nodules had a less favourable prognosis as compared to patients with truly localized disease with a 12% difference in three-year event-free survival.
The diagnostics of bilateral renal tumours (stage V) often is complicated since it may be difficult to distinguish true WT from nephroblastomatosis/ nephrogenic rests, a pre malignant renal (multifocal) anomaly, which may respond to preoperative chemotherapy. An optimal multi-disciplinary sequential diagnostic procedure is required in order to propose the best adapted therapeutic approach to preserve sufficient renal tissue.
- Conditions
- Kidney Cancer
- Being tested
- Radiologic Centralized Review, Tissue sample (tumor, sung, urine)
- Keywords
- pediatric
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiologic Centralized ReviewOther
The patient's imaging will be examined in one of the examination centers
Tissue sample (tumor, sung, urine)Other
all the samples will be made during the patients care
| Study group | Role | What they receive |
|---|---|---|
| children and young adults supported in one of SFCE's centers | Experimental | Not described Receives: Other: Radiologic Centralized Review; Other: Tissue sample (tumor, sung, urine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of tumour chromosomal 1q gain on event-free survival (EFS)
5-year EFS will be analyzed by Kaplan-Meier analysis in all patients with nephroblastoma. The impact of tumour 1gain on 5-year EFS will be analyzed statistically by log-rank analysis comparing those patients with 1q gain with patients withour 1q gain
Measured: 5 years
Impact of tumour chromosomal 1q gain on overall survival (OS)
5-year OS will be analyzed by Kaplan-Meier analysis in all patients with nephroblastoma. The impact of tumour 1gain on 5-year OS will be analyzed statistically by log-rank analysis comparing those patients with 1q gain with patients withour 1q gain
Measured: 5 years
Secondary outcomes (2)
Central radiology review
Central radiology review will be proposed as a novel tool in order to optimize the diagnostics and hence the treatment of patients with renal tumours. As such it will impact the 5-year EFS and OS.
Measured: 5 years
Blastemal residual volume
The impact of balstemal residual volume > 10 ml in the tumour on outcome will be compared to patients with < 10 ml of residual volume. It is anticipated that ther ewill be a statisticla difference in EFS and/or OS.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2019
- Study start1 Aug 2019 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney CancerStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 510 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Olivier ARNAUD, Study director, AP HM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04005820
- Sponsor's protocol ID
- 2018-44
- Acronym
- UMBRELLA
- Status last verified
- Jun 2019
- First submitted
- 12 Jun 2019
- Last updated
- 2 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment for French Pediatric Patients With Renal Tumours According to the International SIOP Renal Tumour Study Group (RTSG) 2016 UMBRELLA Protocol Including Analysis of Tumour Chromosome 1q Gain and Central Radiology Review
- ClinicalTrials.gov ID
- NCT04005820
- Acronym / sponsor ID
- UMBRELLA / 2018-44
- Conditions
- Kidney Cancer
- Keywords
- pediatric
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 510 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 1 Aug 2019 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 2 Jul 2019 (actual)
- 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.
French patients with nephroblastoma (Wilms tumour, WT) have been treated for > 40 years according to International Society of Paediatric Oncology (SIOP) protocols with currently 267 centres across 28 countries collaborating internationally within the SIOP Renal Tumour Study Group (RTSG).
Over the last decades more than 10,000 children have been prospectively enrolled in SIOP WT studies and trials. This has resulted in more standardised diagnostic procedures, improved risk stratification, and adjusted treatment recommendations for most renal tumours. The treatment of patients with renal tumours according to SIOP protocols include preoperative chemotherapy, surgery (tumour-nephrectomy + node-picking ± metastasectomy) followed by risk- and stage-based postoperative chemotherapy ± radiotherapy. Central pathology review is nowadays routinely performed in order to prevent misclassification of stage and histology risk group.
The current SIOP 2001 protocol has come to an end with as major achievement the scientific proof of omitting doxorubicin in stage II and III patients with as a consequence less risk of sequelae. Moreover, in the SIOP 2001 protocol, several tumour biological aspects have been assessed that seem to interfere with outcome (chromosomal gain of 1q, or loss of 1p and 16q, blastemal residual volume). Chromosomal 1q gain is considered to be present in 25-35% of patients with nephroblastoma with a negative impact on event-free survival (EFS) in retrospective analyses. These biological aspects will be studied prospectively as a primary objective in the new SIOP RTSG 2016 UMBRELLA protocol that integrates diagnostics, treatment and follow-up guidelines as well as several research projects.
The main mission of the International Society of Paediatric Oncology (SIOP) Renal Tumour Study Group (RTSG) is to increase survival and to reduce acute treatment toxicity and late effects in all children diagnosed with any renal tumour. In this context, SIOP RTSG is aiming to offer all these patients the same standardized high quality diagnostics and treatment, independent of the tumour type. The new SIOP RTSG 2016 integrated diagnostic and research UMBRELLA protocol serves as an entry for including all children with a renal tumour in the SIOP-RTSG centers, including prospective biomarker analyses. Subsequently, treatment is recommended according to the SIOP RTSG 2016 UMBRELLA treatment guidelines, which provides treatment strategies for all patients with Wilms tumour (WT) and other renal tumours. Central radiology review (CRR) has been proposed as a novel tool within the diagnostic UMBRELLA protocol in order to optimize the diagnostics and hence the treatment.
The definition of metastatic disease in WT remains difficult since pulmonary nodules may not always be of malignant origin. The differential diagnosis of a pulmonary lesion seen in a child with WT is broad. In addition to malignancy, it includes atelectasis, fibrosis, pneumonitis, subpleural lymph nodes, and other infectious or inflammatory lesions. In addition, the issue of "CT-only" nodules in WT and adequate treatment needs to be solved. In previous protocols, the treatment strategy was based on the diagnosis of pulmonary metastases (92% of all metastases) by conventional pulmonary X-ray. Patients with CT-only nodules (= nodules not visible on conventional X-ray) were supposed to be treated as having localized WT. However, retrospective analyses of SIOP series (Smets et al), showed that patients with CT-only nodules had a less favourable prognosis as compared to patients with truly localized disease with a 12% difference in three-year event-free survival.
The diagnostics of bilateral renal tumours (stage V) often is complicated since it may be difficult to distinguish true WT from nephroblastomatosis/ nephrogenic rests, a pre malignant renal (multifocal) anomaly, which may respond to preoperative chemotherapy. An optimal multi-disciplinary sequential diagnostic procedure is required in order to propose the best adapted therapeutic approach to preserve sufficient renal tissue.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| children and young adults supported in one of SFCE's centers | Experimental | Other: Radiologic Centralized Review, Other: Tissue sample (tumor, sung, urine) |
Who may qualify
- Ages
- Up to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Children, adolescents or young adults (up to and including 30 years) with primary or relapsed renal tumor diagnosed at a participating SIOP-RTSG center
- Subject agreeing to participate
Key exclusion criteria (1 listed)
- Absence of informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiologic Centralized ReviewThe patient's imaging will be examined in one of the examination centers | Other | children and young adults supported in one of SFCE's centers |
| Tissue sample (tumor, sung, urine)all the samples will be made during the patients care | Other | children and young adults supported in one of SFCE's centers |
Primary outcome
Impact of tumour chromosomal 1q gain on event-free survival (EFS)
Time frame: 5 years
5-year EFS will be analyzed by Kaplan-Meier analysis in all patients with nephroblastoma. The impact of tumour 1gain on 5-year EFS will be analyzed statistically by log-rank analysis comparing those patients with 1q gain with patients withour 1q gain
Impact of tumour chromosomal 1q gain on overall survival (OS)
Time frame: 5 years
5-year OS will be analyzed by Kaplan-Meier analysis in all patients with nephroblastoma. The impact of tumour 1gain on 5-year OS will be analyzed statistically by log-rank analysis comparing those patients with 1q gain with patients withour 1q gain
2 secondary outcomes
Central radiology review
Time frame: 5 years
Blastemal residual volume
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2019.
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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.
Jean-Olivier ARNAUD study director
AP HM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiologic Centralized Review and Tissue sample (tumor, sung, urine) in people with Kidney Cancer, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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 2 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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 Arnauld VERSCHUUR (33(0)4 91 38 84 78, arnauld.verschuur@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of tumour chromosomal 1q gain on event-free survival (EFS) (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jul 2019.