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RecruitingPhase 1

Ex Vivo Drug Sensitivity Testing and Multi-Omics Profiling

Advancing Personalized Treatment in Pediatric Oncology Through Functional Precision Medicine

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
1 Day to 21 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Biopsies

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Tumor cells collected from tissue taken during routine biopsy or surgery will be tested."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests approved drugs on cancer cells taken from patients and studies the cells’ genes to help find treatment options for each person. It is for patients age 21 or younger in South Florida whose cancer has come back or has not responded to treatment. Cancer cells will come from tissue collected during a routine biopsy or surgery.

Functional precision medicine (FPM) is a relatively new approach to cancer therapy based on direct exposure of patient- isolated tumor cells to clinically approved drugs and integrates ex vivo drug sensitivity testing (DST) and genomic profiling to determine the optimal individualized therapy for cancer patients. In this study, we will enroll relapsed or refractory pediatric cancer patients with tissue available for DST and genomic profiling from the South Florida area, which is 69% Hispanic and 18% Black. Tumor cells collected from tissue taken during routine biopsy or surgery will be tested.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 21 or younger when joining, of any gender, race, or ethnicity.
  • Have suspected or confirmed cancer that has come back or has not responded to treatment.
  • Have recently had or are scheduled for a biopsy or tumor removal, or a bone marrow sample for blood cancer.
  • Be willing to give a blood sample or a swab from inside the cheek for gene testing.
  • You, your parent, or your legal guardian must be willing to sign a consent form.
  • Patients ages 7 to 17 must also be willing to sign a form agreeing to join.

Who can't join

  • No cancer tissue is available or can be accessed for testing.
  • There is not enough cancer tissue for drug testing or gene testing.
  • Have a newly diagnosed tumor or a tumor with a cure rate above 90% using safe standard treatment.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Patients aged 21 years or younger at the time of enrollment on this study of any gender, race or ethnicity. Subjects with suspected or confirmed diagnosis of recurrent or refractory cancer Subjects who are scheduled for or have recently had biopsy or tumor excised (solid tumors) or bone marrow aspirate (blood cancers) Subjects willing to have a blood draw or buccal swab done for the purposes of genetic testing Subjects or their parents or legal guardians willing to sign informed consent Subjects aged 7 to 17 willing to sign assent Exclusion Criteria: * Subjects who do not have malignant tissue available and accessible The amount of excised malignant tissue is not sufficient for the ex vivo drug testing and/or genetic profiling. Patients with newly diagnosed tumors and tumors that have high (\>90%) cure rate with safe standard therapy.

Study sites (1)

FL