Personalized Models for Cancer Research

Solid Tumor, Adult Clinical Trial

Official title:

Personalized Models for Cancer Research

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06350539
• Other study ID #: 10-007
• Status: Recruiting
• Start date: February 15, 2024
• Est. completion date: February 15, 2034

Study information

• Verified date: April 2024
• Source: New York Stem Cell Foundation Research Institute
• Contact: Becca Wood
• Phone: 212-927-1801
• Email: clinicalresearch[@]nyscf.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The New York Stem Cell Foundation (NYSCF) Research Institute is performing this research to accelerate cancer research ranging from disease mechanisms to personalized medicine approaches that will help to realize the promise of precision medicine for oncology.

Description:

Researchers at the New York Stem Cell Foundation (NYSCF) Research Institute will establish a living biobank of tumor/organoids and stem cells representing individual patients diagnosed with cancer. Samples from healthy individuals (non-cancer diagnosis) or from non-disease tissue will also be collected to be used as controls in this study. Information and biospecimens may be transferred to NYSCF by external institution or NYSCF research personnel may prospectively enroll participants to have portions of samples or cells that were (or will be) collected for reasons other than this study transferred into the biobank. NYSCF's researchers hypothesize that the development of patient-specific models that can expand in vitro while capturing tumor complexity at the genotypic and phenotypic levels will enable accelerated discovery of more efficient treatments for patients and improve outcomes. This study is not a clinical trial.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: February 15, 2034
• Est. primary completion date: February 15, 2034
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults ages 18 and older with a solid tumor cancer diagnosis.
• Adults ages 18 and older serving as healthy controls.

Exclusion Criteria:

• Human fetuses.
• Neonates.
• Children.
• Wards of the state.
• Prisoners.

Related Conditions & MeSH terms

• Solid Tumor, Adult

Intervention

Other:
• Biological Sample Collection
Excess/leftover biospecimens that were (or will be) collected for other purposes (e.g., medical procedure).

Locations

Country	Name	City	State
United States	New York Stem Cell Foundation Research Institute	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York Stem Cell Foundation Research Institute	Stevens Institute of Technology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implement organoid culture technologies.	NYSCF will establish patient specific tumor models known as organoids. Organoids are three dimensional cell culture laboratory models with self-organizing capabilities and long-term expansion potential that recapitulate the tissue they are derived from at the histological, molecular, and phenotypic level. We will create organoids from each subject sample collected. Primary outcome measure is successful growth of organoids from individual tumor samples.	Baseline
Primary	Validate genotypic and phenotypic relevance of tumor-derived organoids for biobanking.	To ensure the validity of outcome 1, NYSCF will perform a series of molecular and histological evaluations in primary tissues versus the derived organoid model.	Baseline
Primary	Establish functional testing using organoid cultures alone or in combination with additional cell types.	To validate the clinical utility of the organoid models and the discovery of novel therapeutic strategies, NYSCF will establish methodologies to evaluate organoid responses (i.e., genetic, phenotypic, morphological changes) to small molecules and/or additional treatment modalities such as immunotherapies, antibody-based therapeutics, and others.	Baseline
Primary	Perform drug testing and screens to identify new targets and/or new therapeutic strategies to effectively treat cancer.	As with outcome 3, to validate the clinical utility of the organoid models and the discovery of novel therapeutic strategies, NYSCF will establish methodologies to evaluate organoid responses (i.e., genetic, phenotypic, morphological changes) to small molecules and/or additional treatment modalities such as immunotherapies, antibody-based therapeutics, and others.	Baseline
Primary	Develop a Laboratory Developed Test (LDT) for CLEP/FDA approval that will inform clinicians of each patient's tumor responses to FDA approved drugs.	Tumor organoid models have been shown to recapitulate patient's responses to certain chemotherapies, radiation, and combination regimens used as standard of care. These models hold an unprecedented potential to predict patient's responses preclinically and become an additional resource that clinicians can use to inform treatment decisions. NYSCF will adapt the methodology developed in Outcome 4 to an assay performed under clinical laboratory standards and regulation to pursue clinical certification/FDA approval as per regulatory requirements.	Baseline
Primary	Develop stem cells from individual patient samples to study tumor evolution.	Induced pluripotent stem cells are an invaluable source of patient material with unlimited self-renewal potential that can be used to generate any cell type in the body. By creating iPSCs from each patient's material received at our labs, NYSCF will generate the relevant cell tissue type to study the contribution of germline genetic risk factors to the development of each patient's specific cancers so that we can understand the mechanisms driving tumor evolution and adaptation to therapies as well as the potential of environmental factors and/or the role of immune surveillance that may determine the development of malignant disease. These studies may also lead to the identification of biomarkers for early detection and/or for more effective surveillance before recurrence occurs.	Baseline