Personalized Models for Cancer Research

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 years and older
• All sexes
• Healthy volunteers accepted
• Adult, Older adult

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).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

Conditions

Solid Tumor, Adult

Being tested

Biological Sample Collection

Keywords

cancer, solid tumor

Medical subject headings

Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Biological Sample CollectionOther

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

What is being measured

The primary outcome is the main question the study is designed to answer.

1. 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.

   Measured: Baseline

2. 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.

   Measured: Baseline

3. 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.

   Measured: Baseline

4. 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.

   Measured: Baseline

5. 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.

   Measured: Baseline

6. 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.

   Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted5 Apr 2024
2. Study start15 Feb 2024
3. Primary completion15 Feb 2034 (estimated)
4. Study completion15 Feb 2034 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Solid Tumor, AdultStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.