NeuroblastomaNCT06502210
Identification of New Gene Spliceosomes in Neuroblastoma
An observational study of Neuroblastoma, run by Affiliated Hospital of Nantong University at 1 site in China.
Trial summary
Neuroblastoma is an early childhood embryonic malignancy that originates from neural crest cells. Neuroblastoma shows high heterogeneity in biological, morphological, genetic, and clinical features. Read more about this study
- Who is it for?
- Ages 1 day to 14 years
- Conditions the study is for
- Neuroblastoma
- What is being tested?
- Personalized surgical therapy of neuroblastoma
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2024to 31 Aug 2024
- How long will I take part?
- 3 Months
- 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 1 day to 14 years
- All sexes
- No healthy volunteers
- Child
Study population: The sample is from patients with neuroblastoma who underwent laparoscopic/open neuroblastoma surgery at Nantong University Affiliated Hospital from 2024 to 2026. Children with neuroblastoma range in age from 0 to 14, regardless of gender. Preoperative imaging examinations indicate a patient with neuroblastoma. Before postoperative chemotherapy, the patient's physical strength is good. A preoperative pathological examination of the patient reveals neuroblastoma. Patients have no other history of malignant tumors. Patients voluntarily participate and sign informed consent and can comply with the study visit plan and other protocol requirements.
Who may be able to join
- Children with neuroblastoma range in age from 0 to 14, regardless of gender;
- Preoperative imaging examinations indicate patient with neuroblastoma;
- Before postoperative chemotherapy, the patient's physical strength is good. At the same time, the results of white blood cells, neutrophils, hemoglobin, platelets, and other test indicators are all within normal range, which is in line with the treatment conditions of the relevant chemotherapy and immunotherapy;
- Preoperative pathological examination of the patient reveals neuroblastoma;
- Patients have no other history of malignant tumors;
- Patients voluntarily participate and sign informed consent and can comply with the study visit plan and other protocol requirements.
Who cannot join
- Patients who are found to have distant metastasis or ascites on preoperative examination are excluded;
- Patients with severe liver and kidney dysfunction, as well as those with autoimmune diseases are excluded;
- Patients with severe cardiovascular disease who can not tolerate general anesthesia are excluded;
- Patients who have other malignancies or blood disorders are excluded.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Affiliated Hospital of Nantong University
Nantong, Jiangsu
Wenliang Ge, archiater, 0086-13962854122, gewl@ntu.edu.cn
About this study
Official title: Identification of New Gene Spliceosomes in Neuroblastoma and Their Translational Application in Clinical Accurate Diagnosis and Therapy
Neuroblastoma is an early childhood embryonic malignancy that originates from neural crest cells. Neuroblastoma shows high heterogeneity in biological, morphological, genetic, and clinical features. At present, the main treatment methods for neuroblastoma are surgical treatment combined with chemotherapy after the operation and immunological therapy. However， clinical studies have found that 40%～50% of patients don't have good outcomes after postoperative chemotherapy.
The clinical trial study aims to screen the genotype of children with neuroblastoma and conduct an in-depth analysis of sequencing data and tumor-specific transcripts by using technologies--Deep Sequencing Technology and Third Generation Sequencing Technology.
Read more
The main questions this study aims to answer are： [Question 1]This study will use Third Generation Sequencing technology to find specific transcript variants associated with cancer differentiation; [Question 2]This study will identify possible tissue differential expression by using the Deep Sequencing Technology.
Participants will undergo surgery, during which doctors will remove tumor tissue and adjacent normal tissue. In this experiment, the tumor tissue of children with neuroblastoma will be used as the experimental group, and the adjacent normal tissue will be used as the control group. In this study， the different genotypes of children with neuroblastoma are screened by Deep Sequencing Technology and Third Generation Sequencing Technology. And according to the difference in genotypes， doctors will treat children with neuroblastoma personally. This study hopes to find new single nucleotide polymorphism and therapeutic targets.
Read the detailed description
The clinical trial study aims to screen the genotype of children with neuroblastoma and conduct an in-depth analysis of sequencing data and tumor-specific transcripts using technologies--Deep Sequencing Technology and Third Generation Sequencing Technology. This study hopes to find new single nucleotide polymorphism and therapeutic targets.
Firstly, researchers collect tumor tissues and adjacent normal tissues of 20 children with neuroblastoma meeting the inclusion criteria and collect their clinical data. In this experiment, the tumor tissue of children with neuroblastoma will be used as the experimental group, and the adjacent normal tissue will be used as the control group.
Secondly, researchers will find differentially expressed genes using Deep Sequencing technology and Third Generation Sequencing Technology to sequence 7 neuroblastoma cell lines. The expression of the transcription isoforms was divided into one group of N-myc gene amplification and another group of N-myc gene non-amplification by using Third Generation Sequencing Technology. After extracting the total RNA from tissues, researchers check the RNA's purity, concentration, and integrity. If the RNA is tested up to standard, researchers will build a gene library. After the construction of the gene library is completed, researchers will use the machine to sequence tissues.
Finally, survival analysis and repeated measurements will be used to analyze the data of the experimental group and control group in this experiment. T-test will be used for measurement data. χ2 test will be used for counting data. Kaplan-Meier method and Cox regression analysis will be used for survival analysis. All statistical analyses will be performed using Statistical Analysis Software (Stata 26.0). P < 0.05 is considered significant.
- Conditions
- Neuroblastoma
- Being tested
- Personalized surgical therapy of neuroblastoma
- Keywords
- Neuroblastoma, gene
- Medical subject headings
- Neuroblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized surgical therapy of neuroblastomaProcedure or surgery
If the size of the tumor tissue is too large, the doctor gives the patient chemotherapy and then performs surgery to remove the tumor. In this study, the genotypes of children with neuroblastoma are screened by using Deep Sequencing Technology and Third Generation Sequencing Technology, and the treatment will be performed according to different therapeutic modalities.
| Study group | Role | What they receive |
|---|---|---|
| neuroblastoma group | The resected tumor tissue of patients with neuroblastoma was taken by surgical operation as experimental group. Receives: Procedure: Personalized surgical therapy of neuroblastoma | |
| Normal tissue adjacent to the tumor group | The normal tissue adjacent to tumor of patients with neuroblastoma was taken by surgical operation as control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The differential expression of tissue
The outcome measure is the change in tissue differential expression obtained by comparing the deep sequencing results of neuroblastoma tissue samples and normal tissue samples.
Measured: 1 year
Specific transcript variant
The changes in tumor differentiation-related specific transcripts were found by comparing third-generation sequencing of neuroblastoma tissue sample cell lines.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start1 Apr 2024
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for NeuroblastomaStudies of the same condition, open and under way.
- More trials run by Affiliated Hospital of Nantong UniversityThe 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
- Case-control
- Time perspective
- Other
- Enrolment
- 20 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Nantong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wenliang Ge, archiater, Study chair, Nantong University Affiliated Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06502210
- Sponsor's protocol ID
- LCYJ20242005
- Status last verified
- Apr 2024
- First submitted
- 30 Jun 2024
- Last updated
- 16 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pugh TJ, Morozova O, Attiyeh EF, Asgharzadeh S, Wei JS, Auclair D, Carter SL, Cibulskis K, Hanna M, Kiezun A, Kim J, Lawrence MS, Lichenstein L, McKenna A, Pedamallu CS, Ramos AH, Shefler E, Sivachenko A, Sougnez C, Stewart C, Ally A, Birol I, Chiu R, Corbett RD, Hirst M, Jackman SD, Kamoh B, Khodabakshi AH, Krzywinski M, Lo A, Moore RA, Mungall KL, Qian J, Tam A, Thiessen N, Zhao Y, Cole KA, Diamond M, Diskin SJ, Mosse YP, Wood AC, Ji L, Sposto R, Badgett T, London WB, Moyer Y, Gastier-Foster JM, Smith MA, Guidry Auvil JM, Gerhard DS, Hogarty MD, Jones SJ, Lander ES, Gabriel SB, Getz G, Seeger RC, Khan J, Marra MA, Meyerson M, Maris JM. The genetic landscape of high-risk neuroblastoma. Nat Genet. 2013 Mar;45(3):279-84. doi: 10.1038/ng.2529. Epub 2013 Jan 20.
PubMed 23334666Schramm A, Koster J, Assenov Y, Althoff K, Peifer M, Mahlow E, Odersky A, Beisser D, Ernst C, Henssen AG, Stephan H, Schroder C, Heukamp L, Engesser A, Kahlert Y, Theissen J, Hero B, Roels F, Altmuller J, Nurnberg P, Astrahantseff K, Gloeckner C, De Preter K, Plass C, Lee S, Lode HN, Henrich KO, Gartlgruber M, Speleman F, Schmezer P, Westermann F, Rahmann S, Fischer M, Eggert A, Schulte JH. Mutational dynamics between primary and relapse neuroblastomas. Nat Genet. 2015 Aug;47(8):872-7. doi: 10.1038/ng.3349. Epub 2015 Jun 29.
PubMed 26121086Lopez G, Conkrite KL, Doepner M, Rathi KS, Modi A, Vaksman Z, Farra LM, Hyson E, Noureddine M, Wei JS, Smith MA, Asgharzadeh S, Seeger RC, Khan J, Guidry Auvil J, Gerhard DS, Maris JM, Diskin SJ. Somatic structural variation targets neurodevelopmental genes and identifies SHANK2 as a tumor suppressor in neuroblastoma. Genome Res. 2020 Sep;30(9):1228-1242. doi: 10.1101/gr.252106.119. Epub 2020 Aug 13.
PubMed 32796005Brady SW, Liu Y, Ma X, Gout AM, Hagiwara K, Zhou X, Wang J, Macias M, Chen X, Easton J, Mulder HL, Rusch M, Wang L, Nakitandwe J, Lei S, Davis EM, Naranjo A, Cheng C, Maris JM, Downing JR, Cheung NV, Hogarty MD, Dyer MA, Zhang J. Pan-neuroblastoma analysis reveals age- and signature-associated driver alterations. Nat Commun. 2020 Oct 14;11(1):5183. doi: 10.1038/s41467-020-18987-4.
PubMed 33056981Qiu B, Matthay KK. Advancing therapy for neuroblastoma. Nat Rev Clin Oncol. 2022 Aug;19(8):515-533. doi: 10.1038/s41571-022-00643-z. Epub 2022 May 25.
PubMed 35614230Rickman DS, Schulte JH, Eilers M. The Expanding World of N-MYC-Driven Tumors. Cancer Discov. 2018 Feb;8(2):150-163. doi: 10.1158/2159-8290.CD-17-0273. Epub 2018 Jan 22.
PubMed 29358508Otte J, Dyberg C, Pepich A, Johnsen JI. MYCN Function in Neuroblastoma Development. Front Oncol. 2021 Jan 27;10:624079. doi: 10.3389/fonc.2020.624079. eCollection 2020.
PubMed 33585251Zimmerman MW, Liu Y, He S, Durbin AD, Abraham BJ, Easton J, Shao Y, Xu B, Zhu S, Zhang X, Li Z, Weichert-Leahey N, Young RA, Zhang J, Look AT. MYC Drives a Subset of High-Risk Pediatric Neuroblastomas and Is Activated through Mechanisms Including Enhancer Hijacking and Focal Enhancer Amplification. Cancer Discov. 2018 Mar;8(3):320-335. doi: 10.1158/2159-8290.CD-17-0993. Epub 2017 Dec 28.
PubMed 29284669Rosswog C, Fassunke J, Ernst A, Schomig-Markiefka B, Merkelbach-Bruse S, Bartenhagen C, Cartolano M, Ackermann S, Theissen J, Blattner-Johnson M, Jones B, Schramm K, Altmuller J, Nurnberg P, Ortmann M, Berthold F, Peifer M, Buttner R, Westermann F, Schulte JH, Simon T, Hero B, Fischer M. Genomic ALK alterations in primary and relapsed neuroblastoma. Br J Cancer. 2023 Apr;128(8):1559-1571. doi: 10.1038/s41416-023-02208-y. Epub 2023 Feb 17.
PubMed 36807339Bellini A, Potschger U, Bernard V, Lapouble E, Baulande S, Ambros PF, Auger N, Beiske K, Bernkopf M, Betts DR, Bhalshankar J, Bown N, de Preter K, Clement N, Combaret V, Font de Mora J, George SL, Jimenez I, Jeison M, Marques B, Martinsson T, Mazzocco K, Morini M, Muhlethaler-Mottet A, Noguera R, Pierron G, Rossing M, Taschner-Mandl S, Van Roy N, Vicha A, Chesler L, Balwierz W, Castel V, Elliott M, Kogner P, Laureys G, Luksch R, Malis J, Popovic-Beck M, Ash S, Delattre O, Valteau-Couanet D, Tweddle DA, Ladenstein R, Schleiermacher G. Frequency and Prognostic Impact of ALK Amplifications and Mutations in the European Neuroblastoma Study Group (SIOPEN) High-Risk Neuroblastoma Trial (HR-NBL1). J Clin Oncol. 2021 Oct 20;39(30):3377-3390. doi: 10.1200/JCO.21.00086. Epub 2021 Jun 11.
PubMed 34115544Schulte JH, Eggert A. ALK Inhibitors in Neuroblastoma: A Sprint from Bench to Bedside. Clin Cancer Res. 2021 Jul 1;27(13):3507-3509. doi: 10.1158/1078-0432.CCR-21-0627. Epub 2021 May 4.
PubMed 33947691D'Oto A, Fang J, Jin H, Xu B, Singh S, Mullasseril A, Jones V, Abu-Zaid A, von Buttlar X, Cooke B, Hu D, Shohet J, Murphy AJ, Davidoff AM, Yang J. KDM6B promotes activation of the oncogenic CDK4/6-pRB-E2F pathway by maintaining enhancer activity in MYCN-amplified neuroblastoma. Nat Commun. 2021 Dec 10;12(1):7204. doi: 10.1038/s41467-021-27502-2.
PubMed 34893606Aygun N. Biological and Genetic Features of Neuroblastoma and Their Clinical Importance. Curr Pediatr Rev. 2018;14(2):73-90. doi: 10.2174/1573396314666180129101627.
PubMed 29380702Yue ZX, Xing TY, Zhao W, Zhao Q, Wang XS, Su Y, Gao C, Liu SG, Ma XL. MYCN amplification plus 1p36 loss of heterozygosity predicts ultra high risk in bone marrow metastatic neuroblastoma. Cancer Med. 2022 Apr;11(8):1837-1849. doi: 10.1002/cam4.4583. Epub 2022 Feb 9.
PubMed 35137546Garcia-Lopez J, Wallace K, Otero JH, Olsen R, Wang YD, Finkelstein D, Gudenas BL, Rehg JE, Northcott P, Davidoff AM, Freeman KW. Large 1p36 Deletions Affecting Arid1a Locus Facilitate Mycn-Driven Oncogenesis in Neuroblastoma. Cell Rep. 2020 Jan 14;30(2):454-464.e5. doi: 10.1016/j.celrep.2019.12.048.
PubMed 31940489
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of New Gene Spliceosomes in Neuroblastoma and Their Translational Application in Clinical Accurate Diagnosis and Therapy
- ClinicalTrials.gov ID
- NCT06502210
- Acronym / sponsor ID
- LCYJ20242005
- Conditions
- Neuroblastoma
- Keywords
- Neuroblastoma, gene
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Nantong UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 16 Jul 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.
Neuroblastoma is an early childhood embryonic malignancy that originates from neural crest cells. Neuroblastoma shows high heterogeneity in biological, morphological, genetic, and clinical features. At present, the main treatment methods for neuroblastoma are surgical treatment combined with chemotherapy after the operation and immunological therapy. However， clinical studies have found that 40%～50% of patients don't have good outcomes after postoperative chemotherapy.
The clinical trial study aims to screen the genotype of children with neuroblastoma and conduct an in-depth analysis of sequencing data and tumor-specific transcripts by using technologies--Deep Sequencing Technology and Third Generation Sequencing Technology.
The main questions this study aims to answer are： [Question 1]This study will use Third Generation Sequencing technology to find specific transcript variants associated with cancer differentiation; [Question 2]This study will identify possible tissue differential expression by using the Deep Sequencing Technology.
Participants will undergo surgery, during which doctors will remove tumor tissue and adjacent normal tissue. In this experiment, the tumor tissue of children with neuroblastoma will be used as the experimental group, and the adjacent normal tissue will be used as the control group. In this study， the different genotypes of children with neuroblastoma are screened by Deep Sequencing Technology and Third Generation Sequencing Technology. And according to the difference in genotypes， doctors will treat children with neuroblastoma personally. This study hopes to find new single nucleotide polymorphism and therapeutic targets.
Detailed description
The clinical trial study aims to screen the genotype of children with neuroblastoma and conduct an in-depth analysis of sequencing data and tumor-specific transcripts using technologies--Deep Sequencing Technology and Third Generation Sequencing Technology. This study hopes to find new single nucleotide polymorphism and therapeutic targets.
Firstly, researchers collect tumor tissues and adjacent normal tissues of 20 children with neuroblastoma meeting the inclusion criteria and collect their clinical data. In this experiment, the tumor tissue of children with neuroblastoma will be used as the experimental group, and the adjacent normal tissue will be used as the control group.
Secondly, researchers will find differentially expressed genes using Deep Sequencing technology and Third Generation Sequencing Technology to sequence 7 neuroblastoma cell lines. The expression of the transcription isoforms was divided into one group of N-myc gene amplification and another group of N-myc gene non-amplification by using Third Generation Sequencing Technology. After extracting the total RNA from tissues, researchers check the RNA's purity, concentration, and integrity. If the RNA is tested up to standard, researchers will build a gene library. After the construction of the gene library is completed, researchers will use the machine to sequence tissues.
Finally, survival analysis and repeated measurements will be used to analyze the data of the experimental group and control group in this experiment. T-test will be used for measurement data. χ2 test will be used for counting data. Kaplan-Meier method and Cox regression analysis will be used for survival analysis. All statistical analyses will be performed using Statistical Analysis Software (Stata 26.0). P < 0.05 is considered significant.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| neuroblastoma group | – | Procedure: Personalized surgical therapy of neuroblastomaThe resected tumor tissue of patients with neuroblastoma was taken by surgical operation as experimental group. |
| Normal tissue adjacent to the tumor group | – | –The normal tissue adjacent to tumor of patients with neuroblastoma was taken by surgical operation as control group. |
Who may qualify
- Ages
- 1 day to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The sample is from patients with neuroblastoma who underwent laparoscopic/open neuroblastoma surgery at Nantong University Affiliated Hospital from 2024 to 2026. Children with neuroblastoma range in age from 0 to 14, regardless of gender. Preoperative imaging examinations indicate a patient with neuroblastoma. Before postoperative chemotherapy, the patient's physical strength is good. A preoperative pathological examination of the patient reveals neuroblastoma. Patients have no other history of malignant tumors. Patients voluntarily participate and sign informed consent and can comply with the study visit plan and other protocol requirements.
Key inclusion criteria (6 listed)
- Children with neuroblastoma range in age from 0 to 14, regardless of gender;
- Preoperative imaging examinations indicate patient with neuroblastoma;
- Before postoperative chemotherapy, the patient's physical strength is good. At the same time, the results of white blood cells, neutrophils, hemoglobin, platelets, and other test indicators are all within normal range, which is in line with the treatment conditions of the relevant chemotherapy and immunotherapy;
- Preoperative pathological examination of the patient reveals neuroblastoma;
- Patients have no other history of malignant tumors;
Key exclusion criteria (4 listed)
- Patients who are found to have distant metastasis or ascites on preoperative examination are excluded;
- Patients with severe liver and kidney dysfunction, as well as those with autoimmune diseases are excluded;
- Patients with severe cardiovascular disease who can not tolerate general anesthesia are excluded;
- Patients who have other malignancies or blood disorders are excluded.
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 |
|---|---|---|
| Personalized surgical therapy of neuroblastomaIf the size of the tumor tissue is too large, the doctor gives the patient chemotherapy and then performs surgery to remove the tumor. In this study, the genotypes of children with neuroblastoma are screened by using Deep Sequencing Technology and Third Generation Sequencing Technology, and the treatment will be performed according to different therapeutic modalities. | Procedure or surgery | neuroblastoma group |
Primary outcome
The differential expression of tissue
Time frame: 1 year
The outcome measure is the change in tissue differential expression obtained by comparing the deep sequencing results of neuroblastoma tissue samples and normal tissue samples.
Specific transcript variant
Time frame: 1 year
The changes in tumor differentiation-related specific transcripts were found by comparing third-generation sequencing of neuroblastoma tissue sample cell lines.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- Background: PubMed 23334666Pugh TJ, Morozova O, Attiyeh EF, Asgharzadeh S, Wei JS, Auclair D, Carter SL, Cibulskis K, Hanna M, Kiezun A, Kim J, Lawrence MS, Lichenstein L, McKenna A, Pedamallu CS, Ramos AH, Shefler E, Sivachenko A, Sougnez C, Stewart C, Ally A, Birol I, Chiu R, Corbett RD, Hirst M, Jackman SD, Kamoh B, Khodabakshi AH, Krzywinski M, Lo A, Moore RA, Mungall KL, Qian J, Tam A, Thiessen N, Zhao Y, Cole KA, Diamond M, Diskin SJ, Mosse YP, Wood AC, Ji L, Sposto R, Badgett T, London WB, Moyer Y, Gastier-Foster JM, Smith MA, Guidry Auvil JM, Gerhard DS, Hogarty MD, Jones SJ, Lander ES, Gabriel SB, Getz G, Seeger RC, Khan J, Marra MA, Meyerson M, Maris JM. The genetic landscape of high-risk neuroblastoma. Nat Genet. 2013 Mar;45(3):279-84. doi: 10.1038/ng.2529. Epub 2013 Jan 20.
- Background: PubMed 26121086Schramm A, Koster J, Assenov Y, Althoff K, Peifer M, Mahlow E, Odersky A, Beisser D, Ernst C, Henssen AG, Stephan H, Schroder C, Heukamp L, Engesser A, Kahlert Y, Theissen J, Hero B, Roels F, Altmuller J, Nurnberg P, Astrahantseff K, Gloeckner C, De Preter K, Plass C, Lee S, Lode HN, Henrich KO, Gartlgruber M, Speleman F, Schmezer P, Westermann F, Rahmann S, Fischer M, Eggert A, Schulte JH. Mutational dynamics between primary and relapse neuroblastomas. Nat Genet. 2015 Aug;47(8):872-7. doi: 10.1038/ng.3349. Epub 2015 Jun 29.
- Background: PubMed 32796005Lopez G, Conkrite KL, Doepner M, Rathi KS, Modi A, Vaksman Z, Farra LM, Hyson E, Noureddine M, Wei JS, Smith MA, Asgharzadeh S, Seeger RC, Khan J, Guidry Auvil J, Gerhard DS, Maris JM, Diskin SJ. Somatic structural variation targets neurodevelopmental genes and identifies SHANK2 as a tumor suppressor in neuroblastoma. Genome Res. 2020 Sep;30(9):1228-1242. doi: 10.1101/gr.252106.119. Epub 2020 Aug 13.
- Background: PubMed 33056981Brady SW, Liu Y, Ma X, Gout AM, Hagiwara K, Zhou X, Wang J, Macias M, Chen X, Easton J, Mulder HL, Rusch M, Wang L, Nakitandwe J, Lei S, Davis EM, Naranjo A, Cheng C, Maris JM, Downing JR, Cheung NV, Hogarty MD, Dyer MA, Zhang J. Pan-neuroblastoma analysis reveals age- and signature-associated driver alterations. Nat Commun. 2020 Oct 14;11(1):5183. doi: 10.1038/s41467-020-18987-4.
- Background: PubMed 35614230Qiu B, Matthay KK. Advancing therapy for neuroblastoma. Nat Rev Clin Oncol. 2022 Aug;19(8):515-533. doi: 10.1038/s41571-022-00643-z. Epub 2022 May 25.
- Background: PubMed 29358508Rickman DS, Schulte JH, Eilers M. The Expanding World of N-MYC-Driven Tumors. Cancer Discov. 2018 Feb;8(2):150-163. doi: 10.1158/2159-8290.CD-17-0273. Epub 2018 Jan 22.
- Background: PubMed 33585251Otte J, Dyberg C, Pepich A, Johnsen JI. MYCN Function in Neuroblastoma Development. Front Oncol. 2021 Jan 27;10:624079. doi: 10.3389/fonc.2020.624079. eCollection 2020.
- Background: PubMed 29284669Zimmerman MW, Liu Y, He S, Durbin AD, Abraham BJ, Easton J, Shao Y, Xu B, Zhu S, Zhang X, Li Z, Weichert-Leahey N, Young RA, Zhang J, Look AT. MYC Drives a Subset of High-Risk Pediatric Neuroblastomas and Is Activated through Mechanisms Including Enhancer Hijacking and Focal Enhancer Amplification. Cancer Discov. 2018 Mar;8(3):320-335. doi: 10.1158/2159-8290.CD-17-0993. Epub 2017 Dec 28.
- Background: PubMed 36807339Rosswog C, Fassunke J, Ernst A, Schomig-Markiefka B, Merkelbach-Bruse S, Bartenhagen C, Cartolano M, Ackermann S, Theissen J, Blattner-Johnson M, Jones B, Schramm K, Altmuller J, Nurnberg P, Ortmann M, Berthold F, Peifer M, Buttner R, Westermann F, Schulte JH, Simon T, Hero B, Fischer M. Genomic ALK alterations in primary and relapsed neuroblastoma. Br J Cancer. 2023 Apr;128(8):1559-1571. doi: 10.1038/s41416-023-02208-y. Epub 2023 Feb 17.
- Background: PubMed 34115544Bellini A, Potschger U, Bernard V, Lapouble E, Baulande S, Ambros PF, Auger N, Beiske K, Bernkopf M, Betts DR, Bhalshankar J, Bown N, de Preter K, Clement N, Combaret V, Font de Mora J, George SL, Jimenez I, Jeison M, Marques B, Martinsson T, Mazzocco K, Morini M, Muhlethaler-Mottet A, Noguera R, Pierron G, Rossing M, Taschner-Mandl S, Van Roy N, Vicha A, Chesler L, Balwierz W, Castel V, Elliott M, Kogner P, Laureys G, Luksch R, Malis J, Popovic-Beck M, Ash S, Delattre O, Valteau-Couanet D, Tweddle DA, Ladenstein R, Schleiermacher G. Frequency and Prognostic Impact of ALK Amplifications and Mutations in the European Neuroblastoma Study Group (SIOPEN) High-Risk Neuroblastoma Trial (HR-NBL1). J Clin Oncol. 2021 Oct 20;39(30):3377-3390. doi: 10.1200/JCO.21.00086. Epub 2021 Jun 11.
- Background: PubMed 33947691Schulte JH, Eggert A. ALK Inhibitors in Neuroblastoma: A Sprint from Bench to Bedside. Clin Cancer Res. 2021 Jul 1;27(13):3507-3509. doi: 10.1158/1078-0432.CCR-21-0627. Epub 2021 May 4.
- Background: PubMed 34893606D'Oto A, Fang J, Jin H, Xu B, Singh S, Mullasseril A, Jones V, Abu-Zaid A, von Buttlar X, Cooke B, Hu D, Shohet J, Murphy AJ, Davidoff AM, Yang J. KDM6B promotes activation of the oncogenic CDK4/6-pRB-E2F pathway by maintaining enhancer activity in MYCN-amplified neuroblastoma. Nat Commun. 2021 Dec 10;12(1):7204. doi: 10.1038/s41467-021-27502-2.
- Individual participant dataSharing planned: No
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Endocrine Tumors, Thyroid Neoplasms
RecruitingPhase 1
PEACH TRIAL- Precision Medicine and Adoptive Cellular Therapy
Neuroblastoma, Diffuse Intrinsic Pontine Glioma
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.
Wenliang Ge, archiater study chair
Nantong University Affiliated Hospital
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, run by Affiliated Hospital of Nantong University at 1 site in China.
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 6 inclusion and 4 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 16 Jul 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 China. 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 Wenliang Ge, archiater (0086-13962854122, gewl@ntu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The differential expression of tissue (time frame: 1 year). 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?
On the ClinicalTrials.gov record for NCT06502210, which also lists 32 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 16 Jul 2024.