Personalized Models for Cancer Research

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.

Study Overview

• Status: Recruiting
• Conditions: Solid Tumor, Adult
• Intervention / Treatment: Other: Biological Sample Collection

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Clinical Research Office; Phone Number: 212-927-1801; Email: clinicalresearch@nyscf.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10019
      • Recruiting
      • New York Stem Cell Foundation Research Institute
      • Contact: Clinical Research Office; Phone Number: 212-927-1801; Email: clinicalresearch@nyscf.org
      • Contact: Laura Andres-Martin, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Adults with a solid tumor cancer diagnosis or adults without a medical condition to serve as healthy controls (a comparison group for those with a solid tumor cancer diagnosis).

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy Control; Subjects in this group will serve as healthy controls.	Other: Biological Sample Collection; Excess/leftover biospecimens that were (or will be) collected for other purposes (e.g., medical procedure).
Affected Subjects; Subjects in this group will have a solid tumor cancer diagnosis.	Other: Biological Sample Collection; Excess/leftover biospecimens that were (or will be) collected for other purposes (e.g., medical procedure).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: New York Stem Cell Foundation Research Institute
• Collaborators: Stevens Institute of Technology
• Investigators: Principal Investigator: Laura Andres-Martin, PhD, New York Stem Cell Foundation Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2024
• Primary Completion (Estimated): February 15, 2034
• Study Completion (Estimated): February 15, 2034

Study Registration Dates

• First Submitted: March 21, 2024
• First Submitted That Met QC Criteria: April 1, 2024
• First Posted (Actual): April 5, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 27, 2025
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: cancer; solid tumor
• Other Study ID Numbers: 10-007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No