Feasibility Trial of Darwin OncoTreat and OncoTarget Precision Medicine Testing

This study is testing if it's practical to use two special tests, Darwin OncoTarget and OncoTreat, for people with certain types of cancer that have spread (oligometastatic disease). These tests look at your tumor's RNA (genetic material) to find specific proteins that might be driving the cancer. The goal is to see if doctors can use this information to choose better treatments. You might be able to join if you are an adult with metastatic solid tumor that can be treated with radiation, and have up to 10 tumors. The study will look at whether the tests can be performed, if doctors change treatment based on the results, and if recommended medications can be obtained. This study is currently unclear on its recruitment status and plans to enroll 20 participants.

Study design
This is an interventional feasibility study with a planned enrollment of 20 participants. It is a 'basket design,' meaning it includes patients with different types of solid tumors.
What's involved
If you join, you will need to have a tumor biopsy before the precision medicine testing. Your tumor tissue will then be sent for Darwin OncoTarget and OncoTreat testing.
Compensation
Not stated in the trial record.
Follow-up
The study will track outcomes through study completion, which is an average of 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06842030

Feasibility Trial of Darwin OncoTreat and OncoTarget Precision Medicine Testing

Not Yet Recruiting
NAAges 18+Interventional
Good Samaritan Hospital Medical Center, New York
~20 participants
Updated 2025-02-24 on ClinicalTrials.gov
What's tested:Darwin OncoTarget and OncoTreat

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility: Test Performance Ability To Perform Test Versus Unable to Perform Test with Pathology Samples Needed >50% Tumor Tissue
Measured over Through study completion, an average of 2 years
+3 more outcomes measured
Personalized Medicine
Oligometastatic Disease
Feasibility

NCT06842030

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Good Samaritan University Hospital

    West Islip, New Yorkstudy coordinator listed

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

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Eligibility criteria

Inclusion

Patients age ≥18 years with metastatic solid tumor who are candidates for comprehensive involved site radiotherapy to all areas of disease seen on whole body imaging.
Patients with brain metastases are eligible provided they qualify as oligometastases (up to 10 lesions based on the SABR-COMET-10 trial) and are treatable with radiotherapy to all areas of visible disease.
Patients with adequate bone marrow (absolute neutrophil ≥1000, hemoglobin ≥ 9 g/dl, platelets ≥100,000), kidney (creatinine ≤1.5 times upper limit of normal) and liver (bilirubin ≤1.5 times upper limit of normal).
Patients being treated by radiation oncology at Good Samaritan University Hospital.

Exclusion

Patients with an estimated median survival of less than 6 months using the published and validated NEAT methodology.
Patients who are pregnant and/or breast feeding or those with severe uncontrolled cardiac, pulmonary, infectious or organic brain disease.
  • Feasibility: Test Performance Ability To Perform Test Versus Unable to Perform Test with Pathology Samples Needed >50% Tumor TissueThrough study completion, an average of 2 years

    Proportion of participants whose tumor biopsy successfully undergoes OncoTarget and OncoTreat testing based on sufficient cellularity/DNA/RNA, defined as \>50% tumor.

  • Feasibility: Percent Medication Change Versus No Medication Change Based on Treating Medical Oncologist DecisionThrough study completion, an average of 2 years

    Percentage of participants whose chemotherapy management plan is changed based on the willingness of the medical oncologist to try at least one off-label medication recommended by Darwin testing.

  • Feasibility: Percent Medication Procured Through Insurance and/or Compassionate Use Versus Unable to AttainThrough study completion, an average of 2 years

    Out of the participants who are prescribed a drug from Darwin testing, the percentage that are procured FDA approved on-label and/or off-label agents through insurance or compassionate use in the setting of extensive preauthorization requirements prevalent in community oncology practice.

  • Feasibility: Qualitative Measurement of Barriers Noted Throughout StudyThrough study completion, an average of 2 years

    Quantification and explanation of any unknown barriers that occur throughout the study process preventing an eligible participant from starting a drug recommended by Darwin testing.