Clinical trial NCT04852354: Tissue Collection for Drug Screening and Bioanalysis
Official title: Tissue Collection for Drug Screening and Bioanalysis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Central Nervous System Tumor
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2021-04-21
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a central nervous system tumors. Parents of patients with CNS tumors.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria for Tumor patients undergoing neurosurgery (cohort 1)

1. Subject has presented with a suspected/confirmed neoplastic CNS lesion and is undergoing a neurosurgical procedure in which CNS tissue and/or tumors associated with this tissue will be removed.
2. There must be tissue available in excess of that required by neuropathology for diagnostic purposes.
3. Subject of all ages included.
4. Subjects who are pregnant can be included.
5. Subjects who are neonates (0-4 weeks) can be included.

Inclusion Criteria for Non-tumor patients undergoing neurosurgery (cohort 2)

1. Subject is between 4 weeks and 21 years of age and is undergoing a neurosurgical procedure at WCMC.
2. Subject does not have a CNS tumor diagnosis.
3. Subject should not be pregnant at the time of enrollment.

Inclusion Criteria for Autopsy tumor tissue donation (cohort 3)

1. Subject of all ages included
2. Subject has been diagnosed with a neoplastic CNS lesion at the time of passing.
3. Subjects who are pregnant can be included.
4. Subjects who are neonates (0-4 weeks) can be included.

Inclusion Criteria for parent of tumor patients

1. 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.
2. Subject is the biological parent of patient enrolled in cohort 1.
3. Subject is not pregnant at the time of enrollment.

Primary outcomes:
measure: Evaluating and characterizing the genetic, immunohistochemical, cellular, and molecular profiles of pediatric neoplastic lesions
timeFrame: Through study completion, average 1-3 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Jeffrey Greenfield, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.