NeurofibromatosesNCT03359304
The Neurofibromatosis-associated Tumor Biobank
An observational study of Neurofibromatoses, run by Ren tingting.
Trial summary
Neurofibromatosis-associated Tumor is very rare bone tumor. The investigator set up the biobank to ensure every patient has the chance to participate in future research Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neurofibromatoses
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2018to 1 Mar 2028
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Asia
Who may be able to join
- Proband Inclusion criteria: A diagnosis or suspected diagnosis of neurofibromatosis-associated tumor Family member inclusion criteria: Biological parents and full biological siblings of a case diagnosed with neurofibromatosis-associated tumor
Who cannot join
- non-asian
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Establishment of Neurofibromatosis-associated Tumours Biobank for Future Genomic-based Research Aiming at Improved Outcome Prediction
Neurofibromatosis-associated Tumor is very rare bone tumor. The investigator set up the biobank to ensure every patient has the chance to participate in future research
Read the detailed description
Samples of blood and other stored material such as slides,frozen tissues or leftover diagnostic material.
Questionnaire information, including health history, growth and development, physical activity and family medical history information.
If patients have been diagnosed with a neurofibromatosis-associated tumor or another condition the investigator is interested in， the investigator will ask the patient to release medical record information relating to diagnosis and treatment of neurofibromatosis-associated tumor, other cancers, blood disorders, and similar conditions.
- Conditions
- Neurofibromatoses
- Keywords
- bone tumor
- Medical subject headings
- Neurofibromatoses, Bone Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Detected NF-1 gene expression pattern in neurofibromatosis-asociated tumor
To examine the neurofibromatosis type 1(NF-1) gene expression of the patients with neurofibromatosis-associated tumor
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2017
- Study start1 Mar 2018 (estimated)
- Primary completion1 Mar 2023 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeurofibromatosesStudies 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
- Family based
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ren tingting
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ren tingting, Peking University People's Hospital
- Investigators
- Tingting Ren, phD, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03359304
- Sponsor's protocol ID
- PKU-MPNST
- Status last verified
- Nov 2017
- First submitted
- 25 Nov 2017
- Last updated
- 2 Dec 2017
- Results posted
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of Neurofibromatosis-associated Tumours Biobank for Future Genomic-based Research Aiming at Improved Outcome Prediction
- ClinicalTrials.gov ID
- NCT03359304
- Acronym / sponsor ID
- PKU-MPNST
- Conditions
- Neurofibromatoses
- Keywords
- bone tumor
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Ren tingtingUniversity, hospital or other
- Study start
- 1 Mar 2018 (estimated)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 2 Dec 2017 (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.
Neurofibromatosis-associated Tumor is very rare bone tumor. The investigator set up the biobank to ensure every patient has the chance to participate in future research
Detailed description
Samples of blood and other stored material such as slides,frozen tissues or leftover diagnostic material.
Questionnaire information, including health history, growth and development, physical activity and family medical history information.
If patients have been diagnosed with a neurofibromatosis-associated tumor or another condition the investigator is interested in， the investigator will ask the patient to release medical record information relating to diagnosis and treatment of neurofibromatosis-associated tumor, other cancers, blood disorders, and similar conditions.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Asia
Key inclusion criteria (1 listed)
- Proband Inclusion criteria: A diagnosis or suspected diagnosis of neurofibromatosis-associated tumor Family member inclusion criteria: Biological parents and full biological siblings of a case diagnosed with neurofibromatosis-associated tumor
Key exclusion criteria (1 listed)
- non-asian
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
Detected NF-1 gene expression pattern in neurofibromatosis-asociated tumor
Time frame: 3 years
To examine the neurofibromatosis type 1(NF-1) gene expression of the patients with neurofibromatosis-associated tumor
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 2 Dec 2017.
- Individual participant dataSharing planned: No
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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.
Tingting Ren, phD principal investigator
Peking University People's Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Neurofibromatoses, run by Ren tingting.
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: opening soon, as of the sponsor's last update on 2 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
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 Kuisheng Liu, phD (+8601088324471, tumorcenter@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detected NF-1 gene expression pattern in neurofibromatosis-asociated tumor (time frame: 3 years). 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 Dec 2017.