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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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

Other trials in France

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 groups in NCT04005820
Study groupRoleWhat they receive
children and young adults supported in one of SFCE's centersExperimentalNot 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.

  1. 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

  2. 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)
  1. 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

  2. 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.

  1. First posted2 Jul 2019
  2. Study start1 Aug 2019 (estimated)
  3. Primary completion1 Aug 2026 (estimated)
  4. Study completion1 Aug 2026 (estimated)

Resources

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)
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

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.

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