Central Nervous System TumorNCT04852354
Tissue Collection for Drug Screening and Bioanalysis
An observational study of Central Nervous System Tumor, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The purpose of this study is to improve upon the knowledge currently available about central nervous system (CNS) tumors. We will study the different characteristics of these tumors using tissue samples collected during surgery and post-autopsy. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Central Nervous System Tumor
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jul 2020to 22 Jul 2029
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients with a central nervous system tumors. Parents of patients with CNS tumors.
Who may be able to join
- Subject is the biological parent of a patient undergoing/ who underwent a neurosurgical procedure in which CNS tissue and/or tumors associated with this tissue will be/ was removed.
- Subject is the biological parent of patient enrolled in cohort 1.
- Subject is not pregnant at the time of enrollment.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Weill Cornell Medicine
New York, New York, 10021
Jeffrey Greenfield, M.D., 212-746-2363, jpgreenf@med.cornell.edu
Pediatric Neurosurgery, 212-746-2363, pediatricneurosurgery@med.cornell.edu
About this study
The purpose of this study is to improve upon the knowledge currently available about central nervous system (CNS) tumors. We will study the different characteristics of these tumors using tissue samples collected during surgery and post-autopsy. The aim is to create tumor cell lines and models to test how they respond to different drugs. This research will help improve treatment options and identify new targets for therapy.
Read the detailed description
The goal of this project is to enable the acquisition of tissue available for research with the prospect of enabling the development of new therapeutic avenues for patients diagnosed with cancer in the central nervous system.
During patients' (with a CNS tumor) routine operative procedure, if extra tissue deemed unnecessary for diagnostic or clinical purposes is available, selected samples will undergo DNA and/or RNA extraction and integrity analysis, whole genome and RNA sequencing, DNA and RNA methylome analyses, proteomic analysis, immunoprofiling, and primary culturing of the tumor cells. These cultures may then be used for drug screenings and to create patient-derived xenografts, or for comparisons between tumor and non-tumor patients. Other biological samples may be collected. Tissue collection for drug screening will be extended to post-mortem biospecimens such as whole brain, spinal cord, biofluids (e.g., cerebrospinal fluid and blood) and skin biopsy. These samples will be collected through autopsy donation from pediatric and adult brain tumor patients.
Additionally, saliva samples may be obtained from the parents of pediatric patients with CNS tumors, and biological samples may be collected from pediatric patients without a CNS tumor who are undergoing a neurological procedure. These samples may be used for comparison with samples from patients with CNS tumors.
- Conditions
- Central Nervous System Tumor
- Medical subject headings
- Central Nervous System Neoplasms
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 |
|---|---|---|
| Cohort 1: Tumor patients undergoing neurosurgery | Samples of tumor tissue, blood, CSF, saliva, skull, and dura will be taken during neurosurgery from tumor patients meeting the inclusion criteria. | |
| Parents of tumor patients | Saliva samples will be taken from parents of tumor patients meeting the inclusion criteria. | |
| Cohort 2: Non-Tumor patients undergoing neurosurgery | Blood and CSF samples will be taken from non-tumor patients meeting the inclusion criteria. | |
| Cohort 3: Autopsy tumor tissue donation | Post-mortem biospecimens such as whole brain, spinal cord, biofluids (e.g., cerebrospinal fluid and blood) and skin biopsy will be collected through autopsy donation from brain tumor patients meeting the inclusion criteria. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluating and characterizing the genetic, immunohistochemical, cellular, and molecular profiles of pediatric neoplastic lesions
To develop patient-derived tissue cell lines and xenografts
Measured: Through study completion, average 1-3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start22 Jul 2020
- Primary completion22 Jul 2029 (estimated)
- Study completion22 Jul 2029 (estimated)
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 Central Nervous System TumorStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffrey Greenfield, M.D., Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04852354
- Sponsor's protocol ID
- 20-01021289
- Status last verified
- Dec 2025
- First submitted
- 10 Apr 2021
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rajappa P, Cobb WS, Vartanian E, Huang Y, Daly L, Hoffman C, Zhang J, Shen B, Yanowitch R, Garg K, Cisse B, Haddock S, Huse J, Pisapia DJ, Chan TA, Lyden DC, Bromberg JF, Greenfield JP. Malignant Astrocytic Tumor Progression Potentiated by JAK-mediated Recruitment of Myeloid Cells. Clin Cancer Res. 2017 Jun 15;23(12):3109-3119. doi: 10.1158/1078-0432.CCR-16-1508. Epub 2016 Dec 30.
PubMed 28039266
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tissue Collection for Drug Screening and Bioanalysis
- ClinicalTrials.gov ID
- NCT04852354
- Acronym / sponsor ID
- 20-01021289
- Conditions
- Central Nervous System Tumor
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 22 Jul 2020 (actual)
- Primary completion
- 22 Jul 2029 (estimated)
- Study completion
- 22 Jul 2029 (estimated)
- First posted
- 21 Apr 2021 (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.
The purpose of this study is to improve upon the knowledge currently available about central nervous system (CNS) tumors. We will study the different characteristics of these tumors using tissue samples collected during surgery and post-autopsy. The aim is to create tumor cell lines and models to test how they respond to different drugs. This research will help improve treatment options and identify new targets for therapy.
Detailed description
The goal of this project is to enable the acquisition of tissue available for research with the prospect of enabling the development of new therapeutic avenues for patients diagnosed with cancer in the central nervous system.
During patients' (with a CNS tumor) routine operative procedure, if extra tissue deemed unnecessary for diagnostic or clinical purposes is available, selected samples will undergo DNA and/or RNA extraction and integrity analysis, whole genome and RNA sequencing, DNA and RNA methylome analyses, proteomic analysis, immunoprofiling, and primary culturing of the tumor cells. These cultures may then be used for drug screenings and to create patient-derived xenografts, or for comparisons between tumor and non-tumor patients. Other biological samples may be collected. Tissue collection for drug screening will be extended to post-mortem biospecimens such as whole brain, spinal cord, biofluids (e.g., cerebrospinal fluid and blood) and skin biopsy. These samples will be collected through autopsy donation from pediatric and adult brain tumor patients.
Additionally, saliva samples may be obtained from the parents of pediatric patients with CNS tumors, and biological samples may be collected from pediatric patients without a CNS tumor who are undergoing a neurological procedure. These samples may be used for comparison with samples from patients with CNS tumors.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Tumor patients undergoing neurosurgery | – | –Samples of tumor tissue, blood, CSF, saliva, skull, and dura will be taken during neurosurgery from tumor patients meeting the inclusion criteria. |
| Parents of tumor patients | – | –Saliva samples will be taken from parents of tumor patients meeting the inclusion criteria. |
| Cohort 2: Non-Tumor patients undergoing neurosurgery | – | –Blood and CSF samples will be taken from non-tumor patients meeting the inclusion criteria. |
| Cohort 3: Autopsy tumor tissue donation | – | –Post-mortem biospecimens such as whole brain, spinal cord, biofluids (e.g., cerebrospinal fluid and blood) and skin biopsy will be collected through autopsy donation from brain tumor patients meeting the inclusion criteria. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with a central nervous system tumors. Parents of patients with CNS tumors.
Key inclusion criteria (3 listed)
- Subject is the biological parent of a patient undergoing/ who underwent a neurosurgical procedure in which CNS tissue and/or tumors associated with this tissue will be/ was removed.
- Subject is the biological parent of patient enrolled in cohort 1.
- Subject is not pregnant at the time of enrollment.
Key exclusion criteria (0 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
Evaluating and characterizing the genetic, immunohistochemical, cellular, and molecular profiles of pediatric neoplastic lesions
Time frame: Through study completion, average 1-3 years
To develop patient-derived tissue cell lines and xenografts
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 17 Dec 2025.
- Background: PubMed 28039266Rajappa P, Cobb WS, Vartanian E, Huang Y, Daly L, Hoffman C, Zhang J, Shen B, Yanowitch R, Garg K, Cisse B, Haddock S, Huse J, Pisapia DJ, Chan TA, Lyden DC, Bromberg JF, Greenfield JP. Malignant Astrocytic Tumor Progression Potentiated by JAK-mediated Recruitment of Myeloid Cells. Clin Cancer Res. 2017 Jun 15;23(12):3109-3119. doi: 10.1158/1078-0432.CCR-16-1508. Epub 2016 Dec 30.
- 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.
Jeffrey Greenfield, M.D. principal investigator
Weill Medical College of Cornell University
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 Central Nervous System Tumor, run by Weill Medical College of Cornell University at 1 site in United States.
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 3 inclusion and 0 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 17 Dec 2025. 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 United States. 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 Jeffrey Greenfield, M.D. (212-746-2363, jpgreenf@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluating and characterizing the genetic, immunohistochemical, cellular, and molecular profiles of pediatric neoplastic lesions (time frame: Through study completion, average 1-3 years). 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 NCT04852354, 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 17 Dec 2025.