Nephroblastoma With Vena Cava ThrombosisVINNCT05195411
Vascular Thrombus Involvement in Nephroblastoma
An observational study of Nephroblastoma With Vena Cava Thrombosis, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial summary
Nephroblastoma (Wilms tumor) is the most common kidney tumor in children. It is a malignant embryonic tumor with a good prognosis with more than 85% long-term survival with appropriate chemotherapy, surgery (which most often consists of a total nephrectomy) and radiotherapy for locally invasive forms. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Nephroblastoma With Vena Cava Thrombosis
- How many people
- 72 participants
- Where
- 2 sitesFrance
- Study dates
- 12 Dec 2022to 15 Mar 2023
- 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 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Children with nephroblastoma with vena cava thrombosis +/- atrial extension cared between 1999 and 2019 in Parisian hospitals: Necker and Bicêtre.
Who may be able to join
- Minors with nephroblastoma with vena cava thrombosis +/- atrial extension.
- Cared between 1999 and 2019 in the centers of the study.
Who cannot join
- Other renal and non-renal tumors with vena cava thrombosis.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hôpital Kremlin Bicêtre
Le Kremlin-Bicêtre, 94270
Hôpital Necker-Enfants Malades
Paris, 75015
About this study
Official title: Nephroblastoma With Vena Cava Thrombosis : Multicenter Study Over 20 Years - Analysis of Key Elements of Surgical Management
Nephroblastoma (Wilms tumor) is the most common kidney tumor in children. It is a malignant embryonic tumor with a good prognosis with more than 85% long-term survival with appropriate chemotherapy, surgery (which most often consists of a total nephrectomy) and radiotherapy for locally invasive forms. Some nephroblastomas (approximately 10%) present with vascular extension with vena cava thrombus, a situation which may worsen the prognosis due to the complexity of the surgery. While the oncological treatment of nephroblastoma is highly formalized, to date there is no specific guideline on the surgical management of this rare clinical presentation of nephroblastomas.
The aim of the study is to provide recommendations for the surgical management of nephroblastomas with vena cava thrombus in a large multicenter series.
Read the detailed description
Nephroblastoma (Wilms tumor) is the most common kidney tumor in children. It is a malignant embryonic tumor with a good prognosis with more than 85% long-term survival with appropriate chemotherapy, surgery (which most often consists of a total nephrectomy) and radiotherapy for locally invasive forms. Some nephroblastomas (approximately 10%) present with vascular extension with vena cava thrombus, a situation which may worsen the prognosis due to the complexity of the surgery. While the oncological treatment of nephroblastoma is highly formalized, to date there is no specific guideline on the surgical management of this rare clinical presentation of nephroblastomas.
The management of children with nephroblastomas with vena cava thrombosis is very specific because of the vital risks to diagnosis, especially pulmonary embolism but also cardiac arrest (in the event of extension in the right atrium) and Cerebrovascular accidents by embolism, rarer. Surgery of the primary tumor and its intravascular extension is complex and may require the use of extracorporeal circulation, a source of significant morbidity and even mortality. These patients who will actually have a single kidney are at high risk for renal failure due to possible contralateral kidney damage during surgery. Surgery is not clearly codified because cases are rare, including in expert centers.
The aim of the study is to provide recommendations for the surgical management of nephroblastomas with vena cava thrombus in a large multicenter series.
- Conditions
- Nephroblastoma With Vena Cava Thrombosis
- Keywords
- Nephroblastoma, Wilms tumor, Vena cava thrombosis, Surgical management
- Medical subject headings
- Wilms Tumor
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 |
|---|---|---|
| Nephroblastoma with vena cava thrombosis | Children with nephroblastoma with vena cava thrombosis +/- atrial extension, cared between 1999 and 2019 in Parisian hospitals: Necker and Bicêtre. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Study of the medical file.
Measured: 22 years
Recurrence
Study of the medical file. Local or metastatic recurrence.
Measured: 22 years
Determination of surgical management recommendations
Study of the medical file. Determination of surgical management recommendations based on survival, the occurrence of local or metastatic recurrence and the study of medical care of the patient.
Measured: 2 months
Secondary outcomes (4)
Intraoperative complications
Study of the medical file. Description of intraoperative complications and Dindo-Clavien classification (classification that defines and grades operative complications in 10 grades).
Measured: 1 day
Post-operative complications
Study of the medical file. Description of post-operative complications and Dindo-Clavien classification (classification that defines and grades operative complications in 10 grades).
Measured: 30 days
Long-term sequelae
Study of the medical file. Sequelae linked to the toxicity of chemotherapy, radiotherapy and surgery.
Measured: 20 years
Identify the oncological and / or surgical prognostic risk factors
Study of the medical file. Identify the oncological and / or surgical prognostic risk factors depending on the medical treatment received.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start12 Dec 2022
- Primary completion15 Mar 2023
- Study completion15 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nephroblastoma With Vena Cava ThrombosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Sabine Sarnacki, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de ParisLuca Pio, MD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05195411
- Sponsor's protocol ID
- APHP201331
- Acronym
- VIN
- Status last verified
- Nov 2023
- First submitted
- 4 Jan 2022
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pio L, Abib S, Guerin F, Chardot C, Blanc T, Sarrai N, Martelli H, De Souza FKM, Fanelli MCA, Tamisier D, Guilhen JCS, Le Bret E, Belli E, Fadel E, Cypriano MDS, Minard V, Pasqualini C, Schleiermacher G, Lemelle L, Rod J, Irtan S, Pistorio A, Gauthier F, Branchereau S, Sarnacki S. Surgical Management of Wilms Tumors with Intravenous Extension: A Multicenter Analysis of Clinical Management with Technical Insights. Ann Surg Oncol. 2024 Jul;31(7):4713-4723. doi: 10.1245/s10434-024-15232-w. Epub 2024 Apr 5.
PubMed 38578552
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nephroblastoma With Vena Cava Thrombosis : Multicenter Study Over 20 Years - Analysis of Key Elements of Surgical Management
- ClinicalTrials.gov ID
- NCT05195411
- Acronym / sponsor ID
- VIN / APHP201331
- Conditions
- Nephroblastoma With Vena Cava Thrombosis
- Keywords
- Nephroblastoma, Wilms tumor, Vena cava thrombosis, Surgical management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 12 Dec 2022 (actual)
- Primary completion
- 15 Mar 2023 (actual)
- Study completion
- 15 Mar 2023 (actual)
- First posted
- 19 Jan 2022 (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.
Nephroblastoma (Wilms tumor) is the most common kidney tumor in children. It is a malignant embryonic tumor with a good prognosis with more than 85% long-term survival with appropriate chemotherapy, surgery (which most often consists of a total nephrectomy) and radiotherapy for locally invasive forms. Some nephroblastomas (approximately 10%) present with vascular extension with vena cava thrombus, a situation which may worsen the prognosis due to the complexity of the surgery. While the oncological treatment of nephroblastoma is highly formalized, to date there is no specific guideline on the surgical management of this rare clinical presentation of nephroblastomas.
The aim of the study is to provide recommendations for the surgical management of nephroblastomas with vena cava thrombus in a large multicenter series.
Detailed description
Nephroblastoma (Wilms tumor) is the most common kidney tumor in children. It is a malignant embryonic tumor with a good prognosis with more than 85% long-term survival with appropriate chemotherapy, surgery (which most often consists of a total nephrectomy) and radiotherapy for locally invasive forms. Some nephroblastomas (approximately 10%) present with vascular extension with vena cava thrombus, a situation which may worsen the prognosis due to the complexity of the surgery. While the oncological treatment of nephroblastoma is highly formalized, to date there is no specific guideline on the surgical management of this rare clinical presentation of nephroblastomas.
The management of children with nephroblastomas with vena cava thrombosis is very specific because of the vital risks to diagnosis, especially pulmonary embolism but also cardiac arrest (in the event of extension in the right atrium) and Cerebrovascular accidents by embolism, rarer. Surgery of the primary tumor and its intravascular extension is complex and may require the use of extracorporeal circulation, a source of significant morbidity and even mortality. These patients who will actually have a single kidney are at high risk for renal failure due to possible contralateral kidney damage during surgery. Surgery is not clearly codified because cases are rare, including in expert centers.
The aim of the study is to provide recommendations for the surgical management of nephroblastomas with vena cava thrombus in a large multicenter series.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nephroblastoma with vena cava thrombosis | – | –Children with nephroblastoma with vena cava thrombosis +/- atrial extension, cared between 1999 and 2019 in Parisian hospitals: Necker and Bicêtre. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with nephroblastoma with vena cava thrombosis +/- atrial extension cared between 1999 and 2019 in Parisian hospitals: Necker and Bicêtre.
Key inclusion criteria (2 listed)
- Minors with nephroblastoma with vena cava thrombosis +/- atrial extension.
- Cared between 1999 and 2019 in the centers of the study.
Key exclusion criteria (1 listed)
- Other renal and non-renal tumors with vena cava thrombosis.
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
Survival
Time frame: 22 years
Study of the medical file.
Recurrence
Time frame: 22 years
Study of the medical file. Local or metastatic recurrence.
Determination of surgical management recommendations
Time frame: 2 months
Study of the medical file. Determination of surgical management recommendations based on survival, the occurrence of local or metastatic recurrence and the study of medical care of the patient.
4 secondary outcomes
Intraoperative complications
Time frame: 1 day
Post-operative complications
Time frame: 30 days
Long-term sequelae
Time frame: 20 years
Identify the oncological and / or surgical prognostic risk factors
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Results publication: PubMed 38578552Pio L, Abib S, Guerin F, Chardot C, Blanc T, Sarrai N, Martelli H, De Souza FKM, Fanelli MCA, Tamisier D, Guilhen JCS, Le Bret E, Belli E, Fadel E, Cypriano MDS, Minard V, Pasqualini C, Schleiermacher G, Lemelle L, Rod J, Irtan S, Pistorio A, Gauthier F, Branchereau S, Sarnacki S. Surgical Management of Wilms Tumors with Intravenous Extension: A Multicenter Analysis of Clinical Management with Technical Insights. Ann Surg Oncol. 2024 Jul;31(7):4713-4723. doi: 10.1245/s10434-024-15232-w. Epub 2024 Apr 5.
- Individual participant dataSharing planned: No
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.
Sabine Sarnacki, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
Luca Pio, MD study director
Assistance Publique - Hôpitaux de Paris
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nephroblastoma With Vena Cava Thrombosis, run by Assistance Publique - Hôpitaux de Paris at 2 sites 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: finished, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: 22 years). The study lists 3 primary outcomes in all. 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 NCT05195411, which also lists 1 linked publication.
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 12 Sep 2025.