Clinical trial NCT06350539: Personalized Models for Cancer Research
Official title: Personalized Models for Cancer Research
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Solid Tumor, Adult
Keywords: cancer
solid tumor
Lead sponsor: New York Stem Cell Foundation Research Institute
Sponsor class: OTHER
Collaborators: name: Stevens Institute of Technology
First posted: 2024-04-05
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
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).

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Implement organoid culture technologies.
timeFrame: Baseline
measure: Validate genotypic and phenotypic relevance of tumor-derived organoids for biobanking.
timeFrame: Baseline
measure: Establish functional testing using organoid cultures alone or in combination with additional cell types.
timeFrame: Baseline
measure: Perform drug testing and screens to identify new targets and/or new therapeutic strategies to effectively treat cancer.
timeFrame: Baseline
measure: Develop a Laboratory Developed Test (LDT) for CLEP/FDA approval that will inform clinicians of each patient's tumor responses to FDA approved drugs.
timeFrame: Baseline
measure: Develop stem cells from individual patient samples to study tumor evolution.
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Stem Cell Foundation Research Institute
state: New York
Study officials:
affiliation: New York Stem Cell Foundation Research Institute
name: Laura Andres-Martin, PhD
role: PRINCIPAL_INVESTIGATOR
References: