Personalized Models for Cancer Research

NCT06350539 | Recruiting

• 1 other identifier: 10-007
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Solid Tumor, Adult

Keywords

cancer; solid tumor

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

Affected Subjects

Subjects in this group will have a solid tumor cancer diagnosis.

Other: Biological Sample Collection

Healthy Control

Subjects in this group will serve as healthy controls.

Other: Biological Sample Collection

Interventions

Biological Sample Collection OTHER

Excess/leftover biospecimens that were (or will be) collected for other purposes (e.g., medical procedure).

Affected Subjects; Healthy Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• New York Stem Cell Foundation Research Institute: lead
• Stevens Institute of Technology: collaborator

Study Sites (1)

New York Stem Cell Foundation Research Institute

New York, New York, 10019, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Excess/leftover biospecimens that were (or will be) collected for other purposes (e.g., medical procedure).

MeSH Terms

Conditions

Neoplasms

Study Officials

• Laura Andres-Martin, PhD

  New York Stem Cell Foundation Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Research Office

CONTACT

212-927-1801; clinicalresearch@nyscf.org

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: April 5, 2024
• Study Start: February 15, 2024
• Primary Completion (Estimated): February 15, 2034
• Study Completion (Estimated): February 15, 2034
• Last Updated: March 3, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)