Neurofibromatosis Type 1NCT01218139
Analysis of Peripheral Nerve Sheath Tumors (PNSTs) in Neurofibromatosis Type 1 (NF1) Patients
An observational study of Neurofibromatosis Type 1, run by KU Leuven at 1 site in Belgium.
Trial summary
Neurofibromatosis type 1 (NF1) is a frequent, autosomal dominant disorder caused by heterozygous mutations (intragenic or microdeletion) of the NF1 tumor suppressor gene (chr.17q11.2). One of the clinical features is the development of benign and malignant tumors. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neurofibromatosis Type 1
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2007to Dec 2010
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: population of NF1 patients, seen by prof. Eric Legius, who are having surgery to remove a tumor
Who may be able to join
- NF1 patient
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of Peripheral Nerve Sheath Tumors in Neurofibromatosis Type 1 Patients
Neurofibromatosis type 1 (NF1) is a frequent, autosomal dominant disorder caused by heterozygous mutations (intragenic or microdeletion) of the NF1 tumor suppressor gene (chr.17q11.2). One of the clinical features is the development of benign and malignant tumors. The most common benign tumors in these patients are tumors of the peripheral nerve sheath, named neurofibromas (cutaneous, subcutaneous and plexiform). Every NF1 patient has a life time risk of 8 to 13% of developing a malignant peripheral nerve sheath tumor (MPNST) out of a pre-existing neurofibroma. In patients with a NF1 microdeletion (5% of NF1 patients), this risk is even twice as high compared to patients with an intragenic mutation. MPNSTs lead to a bad prognosis for the patient, with an overall five-year survival of less than 25%. To know more about the development and progression of these tumors, they will be screened by microarray comparative genome hybridization (Leuven) and full exome sequencing (Leuven). Further experiments will be done in cooperation (bidirectional) with the foreign labs of Victor Mautner (Germany), André Bernards (USA), Karen Cichowski (USA) and Yuan Zhu (USA).
For all these experiments, we will make use of tumoral rest material removed from NF1 patients.
Read the detailed description
Introduction Neurofibromatosis type 1 (NF1) is an autosomal dominant disorder occuring in 1 out of 3500 living newborns. The disease is caused by heterozygous mutations of the NF1 gene, located on chromosome 17q11.2. The NF1 gene encodes the tumor suppressor neurofibromin, a negative regulator of the RAS/MAPK pathway. In approximately 95% of patients, the heterozygous mutation is intragenic. The remaining 5% of patients are carrier of a microdeletion, mostly the type 1 deletion, in which apart from the NF1 gene, 14 additional protein coding genes are located.
Clinically, NF1 patients have café-au-lait maculae, freckling, Lisch nodules and neurofibromas. Also cognitive problems, bone lesions and optic pathway gliomas are common in these patients.
Neurofibromas are benign neoplasms of the peripheral nerve sheath, which appear everywhere on the body of almost every NF1 patient. Neurofibromas are composed of different cell types like Schwann cells, fibroblasts, mast cells and perineurial cells. If in Schwann cells of NF1 patients the wild-type NF1 allele is inactivated in a heterozygous microenvironment, a neurofibroma will be formed. There are 3 types of neurofibromas: cutaneous, subcutaneous and plexiform. Cutaneous and subcutaneous neurofibromas appear during adolescence as isolated nodules in or under the skin, respectively. Plexiform neurofibromas are congenital and can spread along a large segment of a peripheral nerve. NF1 microdeletion patients have in general more neurofibromas and they appear at a younger age.
Every NF1 patient has a life time risk of 8 to 13% to develop a malignant peripheral nerve sheath tumor (MPNST) out of a pre-existing (plexiform) neurofibroma. This risk is even twice as high for NF1 microdeletion patients compared to patients with an intragenic mutation. MPNSTs are difficult to diagnose in early phase because of the large number of tumors and diverse locations. These tumors infiltrate easily in surrounding tissue and frequently give rise to metastases. At this moment, the only available treatment is surgical removal of these MPNSTs. Complete resection is often difficult due to the size of the tumors and the location on important nerves. The five-year survival of patients with MPNSTs is less than 25%.
Research protocol All NF1 patients are linked to the UZ Leuven. Their follow-up is done by Prof. Dr. Eric Legius. When the patient is suspected of having a MPNST, the patient is referred to the surgeon of the clinical oncology department, respectively. Also neurofibromas are removed when they are causing problems for the patient. As part of the different tumor care programs in our hospital, a tumor piece is sent from pathology to the centre for human genetics for routine genetical analysis, like karyotyping. In the lab for neurofibromatosis research, the rest material is frozen as tumor pieces and as dissociated cells for research purposes. The samples are stored in a database system that is accessible only for the neurofibromatosis research group. In cooperation with the group of Victor Mautner and Karen Cichowski, the tumor database was further completed with NF1 tumor material and cell lines. The latter samples were coded and could be used as part of our collaboration.
Experimental approach In literature, little is known about the development of a MPNST out of a neurofibroma. In this study we want to gain insight into this process, which can in the end lead to a better diagnosis and treatment of NF1 patients with MPNSTs. For this purpose, only the frozen rest material of neurofibromas and MPNSTs will be used.
At first, DNA will be extracted from the frozen tumor pieces (neurofibromas and MPNSTs). Together with blood DNA (also rest material), the tumor DNA will be screened with microarray genomic hybridization. This technique allows us to check for chromosomal abnormalities, like amplifications and deletions, with a much higher resolution than traditional cytogenetics. In that way, we can look for recurrent alterations within a certain tumor type and for similarities and differences between benign and malignant tumors.
Secondly, the group of MPNSTs will be subdivided in tumors derived from NF1 microdeletion patients and tumors from patients with an intragenic mutation. Recurrent chromosomal gains and losses will be compared between the 2 groups. This will show us if the mechanism of tumor development and progression is different in NF1 microdeletion patients. In cooperation with the group of André Bernards and Karen Cichowski, we will try to elucidate the role of the NF1 microdeletion in the development of neurofibromas. Our group will collect all tumor samples and grow Schwann cells and fibroblasts out of these tumors. The frozen vials with tumor pieces and cultured cells will be encoded and provided to these labs as part of our collaboration.
Subsequently, the DNA derived from 10 different tumors (neurofibromas and MPNSTs) and matching blood DNA will be analyzed by 'full exome sequencing' to check for mutations in all coding exons.
In collaboration with the group of Yuan Zhu, tumor samples will be sent and retrieved in an encoded way.
This study is performed by Eline Beert, PhD student in the lab for neurofibromatosis research, as part of achieving the degree of 'Doctor in Biomedical Sciences', with Prof. Dr. Eric Legius as promotor and main researcher. Only the Catholic University of Leuven and other foreign universities, but no commercial partners (like companies) will participate in this study. The results obtained from the described experiments have to be considered as pure scientific information and none will be reported to the patients.
- Conditions
- Neurofibromatosis Type 1
- Keywords
- neurofibroma, MPNST, array CGH, sequencing
- Medical subject headings
- Neurofibromatosis 1, Neurofibroma, Neurofibrosarcoma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2010 (estimated)
- Study startSep 2007
- Primary completionSep 2010
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurofibromatosis Type 1Studies of the same condition, open and under way.
- More trials run by KU LeuvenThe 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Investigators
- Eric Legius, MD PhD, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01218139
- Sponsor's protocol ID
- LEGIUS_001
- Status last verified
- Oct 2010
- First submitted
- 8 Oct 2010
- Last updated
- 11 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Peripheral Nerve Sheath Tumors in Neurofibromatosis Type 1 Patients
- ClinicalTrials.gov ID
- NCT01218139
- Acronym / sponsor ID
- LEGIUS_001
- Conditions
- Neurofibromatosis Type 1
- Keywords
- neurofibroma, MPNST, array CGH, sequencing
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Sep 2010 (actual)
- Study completion
- Dec 2010 (estimated)
- First posted
- 11 Oct 2010 (estimated)
- 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.
Neurofibromatosis type 1 (NF1) is a frequent, autosomal dominant disorder caused by heterozygous mutations (intragenic or microdeletion) of the NF1 tumor suppressor gene (chr.17q11.2). One of the clinical features is the development of benign and malignant tumors. The most common benign tumors in these patients are tumors of the peripheral nerve sheath, named neurofibromas (cutaneous, subcutaneous and plexiform). Every NF1 patient has a life time risk of 8 to 13% of developing a malignant peripheral nerve sheath tumor (MPNST) out of a pre-existing neurofibroma. In patients with a NF1 microdeletion (5% of NF1 patients), this risk is even twice as high compared to patients with an intragenic mutation. MPNSTs lead to a bad prognosis for the patient, with an overall five-year survival of less than 25%. To know more about the development and progression of these tumors, they will be screened by microarray comparative genome hybridization (Leuven) and full exome sequencing (Leuven). Further experiments will be done in cooperation (bidirectional) with the foreign labs of Victor Mautner (Germany), André Bernards (USA), Karen Cichowski (USA) and Yuan Zhu (USA).
For all these experiments, we will make use of tumoral rest material removed from NF1 patients.
Detailed description
Introduction Neurofibromatosis type 1 (NF1) is an autosomal dominant disorder occuring in 1 out of 3500 living newborns. The disease is caused by heterozygous mutations of the NF1 gene, located on chromosome 17q11.2. The NF1 gene encodes the tumor suppressor neurofibromin, a negative regulator of the RAS/MAPK pathway. In approximately 95% of patients, the heterozygous mutation is intragenic. The remaining 5% of patients are carrier of a microdeletion, mostly the type 1 deletion, in which apart from the NF1 gene, 14 additional protein coding genes are located.
Clinically, NF1 patients have café-au-lait maculae, freckling, Lisch nodules and neurofibromas. Also cognitive problems, bone lesions and optic pathway gliomas are common in these patients.
Neurofibromas are benign neoplasms of the peripheral nerve sheath, which appear everywhere on the body of almost every NF1 patient. Neurofibromas are composed of different cell types like Schwann cells, fibroblasts, mast cells and perineurial cells. If in Schwann cells of NF1 patients the wild-type NF1 allele is inactivated in a heterozygous microenvironment, a neurofibroma will be formed. There are 3 types of neurofibromas: cutaneous, subcutaneous and plexiform. Cutaneous and subcutaneous neurofibromas appear during adolescence as isolated nodules in or under the skin, respectively. Plexiform neurofibromas are congenital and can spread along a large segment of a peripheral nerve. NF1 microdeletion patients have in general more neurofibromas and they appear at a younger age.
Every NF1 patient has a life time risk of 8 to 13% to develop a malignant peripheral nerve sheath tumor (MPNST) out of a pre-existing (plexiform) neurofibroma. This risk is even twice as high for NF1 microdeletion patients compared to patients with an intragenic mutation. MPNSTs are difficult to diagnose in early phase because of the large number of tumors and diverse locations. These tumors infiltrate easily in surrounding tissue and frequently give rise to metastases. At this moment, the only available treatment is surgical removal of these MPNSTs. Complete resection is often difficult due to the size of the tumors and the location on important nerves. The five-year survival of patients with MPNSTs is less than 25%.
Research protocol All NF1 patients are linked to the UZ Leuven. Their follow-up is done by Prof. Dr. Eric Legius. When the patient is suspected of having a MPNST, the patient is referred to the surgeon of the clinical oncology department, respectively. Also neurofibromas are removed when they are causing problems for the patient. As part of the different tumor care programs in our hospital, a tumor piece is sent from pathology to the centre for human genetics for routine genetical analysis, like karyotyping. In the lab for neurofibromatosis research, the rest material is frozen as tumor pieces and as dissociated cells for research purposes. The samples are stored in a database system that is accessible only for the neurofibromatosis research group. In cooperation with the group of Victor Mautner and Karen Cichowski, the tumor database was further completed with NF1 tumor material and cell lines. The latter samples were coded and could be used as part of our collaboration.
Experimental approach In literature, little is known about the development of a MPNST out of a neurofibroma. In this study we want to gain insight into this process, which can in the end lead to a better diagnosis and treatment of NF1 patients with MPNSTs. For this purpose, only the frozen rest material of neurofibromas and MPNSTs will be used.
At first, DNA will be extracted from the frozen tumor pieces (neurofibromas and MPNSTs). Together with blood DNA (also rest material), the tumor DNA will be screened with microarray genomic hybridization. This technique allows us to check for chromosomal abnormalities, like amplifications and deletions, with a much higher resolution than traditional cytogenetics. In that way, we can look for recurrent alterations within a certain tumor type and for similarities and differences between benign and malignant tumors.
Secondly, the group of MPNSTs will be subdivided in tumors derived from NF1 microdeletion patients and tumors from patients with an intragenic mutation. Recurrent chromosomal gains and losses will be compared between the 2 groups. This will show us if the mechanism of tumor development and progression is different in NF1 microdeletion patients. In cooperation with the group of André Bernards and Karen Cichowski, we will try to elucidate the role of the NF1 microdeletion in the development of neurofibromas. Our group will collect all tumor samples and grow Schwann cells and fibroblasts out of these tumors. The frozen vials with tumor pieces and cultured cells will be encoded and provided to these labs as part of our collaboration.
Subsequently, the DNA derived from 10 different tumors (neurofibromas and MPNSTs) and matching blood DNA will be analyzed by 'full exome sequencing' to check for mutations in all coding exons.
In collaboration with the group of Yuan Zhu, tumor samples will be sent and retrieved in an encoded way.
This study is performed by Eline Beert, PhD student in the lab for neurofibromatosis research, as part of achieving the degree of 'Doctor in Biomedical Sciences', with Prof. Dr. Eric Legius as promotor and main researcher. Only the Catholic University of Leuven and other foreign universities, but no commercial partners (like companies) will participate in this study. The results obtained from the described experiments have to be considered as pure scientific information and none will be reported to the patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- population of NF1 patients, seen by prof. Eric Legius, who are having surgery to remove a tumor
Key inclusion criteria (1 listed)
- NF1 patient
Key exclusion criteria (1 listed)
- -
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2010.
Related trials for Neurofibromatosis Type 1
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
RecruitingPhase 3
A Study of the Drugs Selumetinib vs. Carboplatin and Vincristine in Patients With Low-Grade Glioma
Low Grade Astrocytoma, Low Grade Glioma
RecruitingPhase 1
Phase I Trial of TURALIO(R) (Pexidartinib, PLX3397) in Children and Young Adults With Refractory Leukemias and Refractory Solid Tumors Including Neurofibromatosis Type 1 (NF1) Associated Plexiform Neurofibromas (PN) and Tenosynovial Giant Cell Tumor ...
Neurofibroma, Plexiform, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Active, not recruitingPhase 2
Trametinib in Treating Patients With Relapsed or Refractory Juvenile Myelomonocytic Leukemia
Juvenile Myelomonocytic Leukemia, Neurofibromatosis Type 1
RecruitingObservational study
Surveillance for Malignant Transformation of Neurofibromatosis Type 1 (NF1) Related Peripheral Nerve Sheath Tumors (PNST)
Neurofibromatosis 1, Nerve Sheath Neoplasms
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.
Eric Legius, MD PhD principal investigator
KU Leuven
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 Neurofibromatosis Type 1, run by KU Leuven at 1 site in Belgium.
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 1 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 11 Oct 2010. 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 Belgium. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 11 Oct 2010.