Feasibility Trial of Darwin OncoTreat and OncoTarget Precision Medicine Testing

Part of paid clinical trials in West Islip, New York.

Sponsor
Good Samaritan Hospital Medical Center, New York
Study ID
NCT06842030
Status
Not Yet Recruiting

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Conditions

  • Feasibility
  • Oligometastatic Disease
  • Personalized Medicine

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Darwin OncoTarget and OncoTreat — DIAGNOSTIC_TEST
    Darwin OncoTarget and OncoTreat predict potential drugs with early markers of efficacy in early human clinical trials. Specifically, OncoTarget identifies high-affinity inhibitors of master regulator proteins, while OncoTreat identifies tumor-checkpoint module inhibitors that modulate the transcriptional activity of hyper-connected master regulators. These tests are now commercially available with Clinical Laboratory Improvement Amendments (CLIA) approval through Columbia Presbyterian Medical Center.

Study Details

This is a feasibility trial to assess use of OncoTarget and OncoTreat testing in a basket design of patients with oligmetastasis across various solid tumor histology. Eligible oligometastatic patients that are receiving radiation therapy (n=20) will undergo mandatory tumor biopsy prior to precision medicine testing. Formalin fixed paraffin embedded tissue with \>50% tumor will be sent to the Laboratory of Personalized Genomic Medicine at Columbia University Medical Center for Darwin OncoTarget and OncoTreat testing. This will be supplementing routine clinical care with the goal of improving outcomes. The treating oncologist will decide to administer standard of care systemic therapy or proceed with treatment recommended by precision medicine testing. Feasibility outcomes include the ability to have the OncoTarget and OncoTreat test performed based on tumor type and pathology, ability to procure agents, change in medication use, and identification of unknown barriers. This study is assessing the use of precision medicine in a population has documented poor outcomes with implications aimed at improving these outcomes.

Key Dates

Start date
Mar 10, 2025
Status verified
Feb 2025
Primary completion
Apr 10, 2027
Completion
Apr 10, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Feasibility
    All study participants will get the same study intervention. It will include the usual radiation to all areas of visible disease. Systemic therapy will be determined by your medical oncologist with the supplemental information provided by the Darwin OncoTarget and OncoTreat test.

Primary Outcome Measure

Feasibility: Test Performance Ability To Perform Test Versus Unable to Perform Test with Pathology Samples Needed >50% Tumor Tissue [ Time Frame: Through study completion, an average of 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Good Samaritan University HospitalWest IslipNew York11795
Lara Rush
[email protected]
631-376-3093
Johnny Kao, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Good Samaritan University Hospital· West Islip, NY

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