NeuroblastomaANLAP-RNCT06296732
Abdominal Neuroblastoma Laparoscopic Surgery Risk Factors Stratification
An observational study of Neuroblastoma and Ganglioneuroma, run by Federal Research Institute of Pediatric Hematology, Oncology and Immunology at 1 site in Russia.
Trial summary
Surgery plays significant role in treatment of neurogenic tumors, both for benign ganglioneuroma and for high risk neuroblastoma. The world literature has accumulated large experience in laparoscopic surgery for abdominal neuroblastoma. Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Neuroblastoma, Ganglioneuroma, Ganglioneuroblastoma
- What is being tested?
- Duration of surgery intervention
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteRussia
- Study dates
- 19 Oct 2023to 1 Nov 2031
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 1 day to 18 years
- All sexes
- Child, Adult
Study population: Patients with abdominal neurogenic tumors in 0-18 years of age
Who may be able to join
- Patients with neurogenic tumors meeting the criteria of groups I-III:
- Group I
- low or moderate risk group according to pilot difficulty scoring system (less than 5 points, see supplementary material);
- no IDRF;
- Group II:
- low or moderate risk group according to pilot difficulty scoring system (less than 5 points);
Show all 16Show fewer
- patients with any number of IDRFs and without central tumor location and/or tumor extension across the midline and/or tumor volume (cm3)/patient height (m) ratio = 28 or more.
- Group III:
- 2 and more IDRF + central tumor location and/or tumor extension across the midline;
- 2 and more IDRF + tumor volume (cm3)/patient height (m) ratio = 28 or more;
- 2 and more IDRF + 2 and more other risk factors according to pilot difficulty scoring system;
- 1 IDRF + tumor extension across the midline + tumor volume (cm3)/patient height (m) ratio = 28 or more.
- Age from 0 to 18 years.
- Preoperative imaging (abdominal contrast-enhanced computed tomography (CT), performed no later than 14 days before the planned surgery).
- Indications for surgery based on the decision of multidisciplinary experts board in centers- participants.
- Written voluntary informed consent of the patient and / or his legal representative.
Who cannot join
- 3 and more IDRF + central tumor location and/or tumor extension across the midline and/or tumor volume (cm3)/patient height (m) ratio = 28 or more.
- Severe concomitant pathology, increasing anesthesiologic and surgical risks, via the desicion of the research physician or conclusion by multidisciplinary team in centers- participants.
- Tumor volume does not technically allow to provide minimally-invasive surgery, based on the conclusion of multidisciplinary experts board team in centers- participants.
- Therapy strategy: observation
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
Research Institute of Pediatric Hematology, Oncology and Immunology
Moscow
Dmitry m Akhaladze, MD, Doc, +7 (905) 587-89-92,, d.g.akhaladze@gmail.com
About this study
Surgery plays significant role in treatment of neurogenic tumors, both for benign ganglioneuroma and for high risk neuroblastoma. The world literature has accumulated large experience in laparoscopic surgery for abdominal neuroblastoma. The presence of IDRF (image-defined risk factors) and tumor size (>4-7 cm) are considered as common contraindications for minimally invasive surgery in neuroblastoma. However, the recent studies have shown that presence of IDRF is not an absolute contraindication for laparoscopic surgery. This open-label, nonrandomized, observational, phase III evaluates role and weight of different surgical risk factors (including IDRF, tumor size, tumor localization, tumor volume/patient height ratio, previous open surgical procedures, previous chemotherapy etc.) in the laparoscopic neuroblastoma resections. The aim of this study is to create novel risk factors scoring system for laparoscopic surgery in abdominal neuroblastoma.
Read the detailed description
After signing informed consent and surgical risk factors assessment (see Study Documents), eligible patients received surgical treatment - laparoscopic neuroblastoma resection. Parameters to be assessed are: duration of surgery intervention, intraoperative complications, blood loss volume, cases and volume of blood transfusion, conversion from laparoscopic to cavity access, surgeon's visual assessment completeness of the tumor resection. During 5 postoperative days patients undergo contrast-enhanced abdominal computed tomography (CT) to control completeness of the tumor resection assessment. Postoperative complications during 30 postoperative days to be accessed. In follow up period 1-, 3- and 5 years local recurrence-free survival to be accessed.
- Conditions
- Neuroblastoma, Ganglioneuroma, Ganglioneuroblastoma
- Being tested
- Duration of surgery intervention
- Keywords
- Neuroblastoma, Ganglioneuroma, Ganglioneuroblastoma, Laparoscopic surgery, Minimally-Invasive surgery, IDRF - image-defined risk factors, Risk factors, Difficulty scoring system, Complete resection
- Medical subject headings
- Neuroblastoma, Ganglioneuroma, Ganglioneuroblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Duration of surgery interventionProcedure or surgery
Intraoperative- duration from the beginning of the skin incision to skin suture (min)
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of surgery intervention
Pilot difficulty scoring system for laparoscopic surgery in abdominal neuroblastoma
Measured: Intraoperative
Secondary outcomes (4)
The influence of surgical risk factors
The influence of surgical risk factors (see supplementary material) on the surgery results (see supplementary material) and the course of the postoperative period.
Measured: Intraoperative and 30 days postoperative
Cases of conversion from laparoscopic to cavity access
Measured: Intraoperative
Comparison of surgeon's visual assessment of the tumor resection
Comparison of surgeon's visual assessment of the tumor resection completeness with data from abdominal contrast-enhanced CT, performed in the first 5 days after surgery.
Measured: 5 days postoperative
1-, 3-, 5-years local recurrence-free survival
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start19 Oct 2023
- Primary completion26 Oct 2026 (estimated)
- Study completion1 Nov 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeuroblastomaStudies 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
- 200 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Federal Research Institute of Pediatric Hematology, Oncology and Immunology
- Sponsor type
- University, hospital or other
- Collaborators
- University Medical Center, Kazakhstan
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06296732
- Sponsor's protocol ID
- NCPHOI-2024-01
- Acronym
- ANLAP-R
- Status last verified
- Feb 2024
- First submitted
- 29 Feb 2024
- Last updated
- 20 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abdominal Neuroblastoma Laparoscopic Surgery Risk Factors Stratification
- ClinicalTrials.gov ID
- NCT06296732
- Acronym / sponsor ID
- ANLAP-R / NCPHOI-2024-01
- Conditions
- Neuroblastoma, Ganglioneuroma, Ganglioneuroblastoma
- Keywords
- Neuroblastoma, Ganglioneuroma, Ganglioneuroblastoma, Laparoscopic surgery, Minimally-Invasive surgery, IDRF - image-defined risk factors, Risk factors, Difficulty scoring system
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Federal Research Institute of Pediatric Hematology, Oncology and ImmunologyUniversity, hospital or other
- Collaborators
- University Medical Center, Kazakhstan
- Study start
- 19 Oct 2023 (actual)
- Primary completion
- 26 Oct 2026 (estimated)
- Study completion
- 1 Nov 2031 (estimated)
- First posted
- 6 Mar 2024 (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.
Surgery plays significant role in treatment of neurogenic tumors, both for benign ganglioneuroma and for high risk neuroblastoma. The world literature has accumulated large experience in laparoscopic surgery for abdominal neuroblastoma. The presence of IDRF (image-defined risk factors) and tumor size (>4-7 cm) are considered as common contraindications for minimally invasive surgery in neuroblastoma. However, the recent studies have shown that presence of IDRF is not an absolute contraindication for laparoscopic surgery. This open-label, nonrandomized, observational, phase III evaluates role and weight of different surgical risk factors (including IDRF, tumor size, tumor localization, tumor volume/patient height ratio, previous open surgical procedures, previous chemotherapy etc.) in the laparoscopic neuroblastoma resections. The aim of this study is to create novel risk factors scoring system for laparoscopic surgery in abdominal neuroblastoma.
Detailed description
After signing informed consent and surgical risk factors assessment (see Study Documents), eligible patients received surgical treatment - laparoscopic neuroblastoma resection. Parameters to be assessed are: duration of surgery intervention, intraoperative complications, blood loss volume, cases and volume of blood transfusion, conversion from laparoscopic to cavity access, surgeon's visual assessment completeness of the tumor resection. During 5 postoperative days patients undergo contrast-enhanced abdominal computed tomography (CT) to control completeness of the tumor resection assessment. Postoperative complications during 30 postoperative days to be accessed. In follow up period 1-, 3- and 5 years local recurrence-free survival to be accessed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Patients with abdominal neurogenic tumors in 0-18 years of age
Key inclusion criteria (16 listed)
- Patients with neurogenic tumors meeting the criteria of groups I-III:
- Group I
- Age from 0 to 18 years.
- Preoperative imaging (abdominal contrast-enhanced computed tomography (CT), performed no later than 14 days before the planned surgery).
- Indications for surgery based on the decision of multidisciplinary experts board in centers- participants.
Key exclusion criteria (5 listed)
- 3 and more IDRF + central tumor location and/or tumor extension across the midline and/or tumor volume (cm3)/patient height (m) ratio = 28 or more.
- Severe concomitant pathology, increasing anesthesiologic and surgical risks, via the desicion of the research physician or conclusion by multidisciplinary team in centers- participants.
- Tumor volume does not technically allow to provide minimally-invasive surgery, based on the conclusion of multidisciplinary experts board team in centers- participants.
- Therapy strategy: observation
- -
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 |
|---|---|---|
| Duration of surgery interventionIntraoperative- duration from the beginning of the skin incision to skin suture (min) | Procedure or surgery | – |
Primary outcome
Duration of surgery intervention
Time frame: Intraoperative
Pilot difficulty scoring system for laparoscopic surgery in abdominal neuroblastoma
4 secondary outcomes
The influence of surgical risk factors
Time frame: Intraoperative and 30 days postoperative
Cases of conversion from laparoscopic to cavity access
Time frame: Intraoperative
Comparison of surgeon's visual assessment of the tumor resection
Time frame: 5 days postoperative
1-, 3-, 5-years local recurrence-free survival
Time frame: up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuroblastoma and Ganglioneuroma, run by Federal Research Institute of Pediatric Hematology, Oncology and Immunology at 1 site in Russia.
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 16 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 20 May 2024. 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 Russia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dmitry Akhaladze, MD, Doc (+7 (905) 587-89-92, d.g.akhaladze@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of surgery intervention (time frame: Intraoperative). 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 20 May 2024.