Recruiting

Observational Study

Sponsor:

New York Stem Cell Foundation Research Institute

Code:

NCT06350539

Conditions

Solid Tumor, Adult

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Biological Sample Collection

Study Details

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

Study ID

NCT06350539

Start date

Feb 15, 2024

Status verified date

Jul, 2024

Completion date

Feb 15, 2034

Anticipated

Primary completion date

Feb 15, 2034

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

Affected Subjects

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

Healthy Control

Subjects in this group will serve as healthy controls.

Interventions

Biological Sample Collection

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

Primary outcome measure

  • Implement organoid culture technologies. [ Time Frame: Baseline ]
  • Validate genotypic and phenotypic relevance of tumor-derived organoids for biobanking. [ Time Frame: Baseline ]
  • Establish functional testing using organoid cultures alone or in combination with additional cell types. [ Time Frame: Baseline ]
  • Perform drug testing and screens to identify new targets and/or new therapeutic strategies to effectively treat cancer. [ Time Frame: 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. [ Time Frame: Baseline ]
  • Develop stem cells from individual patient samples to study tumor evolution. [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Clinical Research Office

212-927-1801clinicalresearch@nyscf.org

Locations

New York Stem Cell Foundation Research Institute

Recruiting

New York, New York, United States, 10019

Contacts

Clinical Research Office

212-927-1801clinicalresearch@nyscf.org

Principal Investigator:

Laura Andres-Martin, PhD

More Information

Sponsor

New York Stem Cell Foundation Research Institute

Last update posted

Mar 3, 2025

Last verified

Jul, 2024

Keywords

  • cancer
  • solid tumor

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by New York Stem Cell Foundation Research Institute on 2025-03-03.