Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
16

Inclusion Criteria

Subjects aged 7 to 17 willing to sign assent
Subjects or their parents or legal guardians willing to sign informed consent
Subjects with suspected or confirmed diagnosis of recurrent or refractory cancer
...
Subjects aged 7 to 17 willing to sign assent
Subjects or their parents or legal guardians willing to sign informed consent
Subjects with suspected or confirmed diagnosis of recurrent or refractory cancer
Subjects willing to have a blood draw or buccal swab done for the purposes of genetic testing
Subjects who are scheduled for or have recently had biopsy or tumor excised (solid tumors) or bone marrow aspirate (blood cancers)

Exclusion Criteria

The amount of excised malignant tissue is not sufficient for the ex vivo drug testing and/or genetic profiling.
Subjects who do not have malignant tissue available and accessible
Patients with newly diagnosed tumors and tumors that have high (>90%) cure rate with safe standard therapy.
The amount of excised malignant tissue is not sufficient for the ex vivo drug testing and/or genetic profiling.
Subjects who do not have malignant tissue available and accessible
Patients with newly diagnosed tumors and tumors that have high (>90%) cure rate with safe standard therapy.

Summary

Conditions
  • Recurrent Childhood Acute Lymphoblastic Leukemia
  • Recurrent Childhood Acute Myeloid Leukemia
  • Recurrent Childhood Brain Tumor
  • Recurrent Childhood Brainstem Glioma
  • Recurrent Childhood Ependymoma
  • Recurrent Childhood Gliosarcoma
  • Refractory Childhood Hodgkin Lymphoma
  • Refractory Chronic Myelogenous Leukemia, BCR-ABL1 Positive
  • Recurrent Childhood Large Cell Lymphoma
  • Recurrent Childhood Lymphoblastic Lymphoma
  • Recurrent Childhood Rhabdomyosarcoma
  • Recurrent Childhood Soft Tissue Sarcoma
  • Refractory Childhood Malignant Germ Cell Neoplasm
  • Refractory Childhood Acute Lymphoblastic Leukemia
Type
Observational
Design
  • Observational Model: Cohort
  • Time Perspective: Prospective

Participation Requirements

Age
Younger than 21 years
Gender
Both males and females

Description

PRIMARY OBJECTIVE: The primary objective of the study is to determine feasibility of providing pediatric cancer patients with access to personalized treatment options and clinical management recommendations based on ex vivo drug sensitivity testing (DST) and genomic profiling. SECONDARY OBJECTIVE: T...

PRIMARY OBJECTIVE: The primary objective of the study is to determine feasibility of providing pediatric cancer patients with access to personalized treatment options and clinical management recommendations based on ex vivo drug sensitivity testing (DST) and genomic profiling. SECONDARY OBJECTIVE: The secondary objective of the study is to compare individual outcomes (response and disease-free survival) in patients with pediatric cancers treated with DST-guided therapy as compared to non-DST guided (conventional) therapy. EXPLORATORY OBJECTIVE: To explore associations between genetic abnormalities in malignancies and ex vivo drug response.

Inclusion Criteria

Subjects aged 7 to 17 willing to sign assent
Subjects or their parents or legal guardians willing to sign informed consent
Subjects with suspected or confirmed diagnosis of recurrent or refractory cancer
...
Subjects aged 7 to 17 willing to sign assent
Subjects or their parents or legal guardians willing to sign informed consent
Subjects with suspected or confirmed diagnosis of recurrent or refractory cancer
Subjects willing to have a blood draw or buccal swab done for the purposes of genetic testing
Subjects who are scheduled for or have recently had biopsy or tumor excised (solid tumors) or bone marrow aspirate (blood cancers)

Exclusion Criteria

The amount of excised malignant tissue is not sufficient for the ex vivo drug testing and/or genetic profiling.
Subjects who do not have malignant tissue available and accessible
Patients with newly diagnosed tumors and tumors that have high (>90%) cure rate with safe standard therapy.
The amount of excised malignant tissue is not sufficient for the ex vivo drug testing and/or genetic profiling.
Subjects who do not have malignant tissue available and accessible
Patients with newly diagnosed tumors and tumors that have high (>90%) cure rate with safe standard therapy.

Locations

Miami, Florida, 33155
Miami, Florida, 33155

Tracking Information

NCT #
NCT03860376
Collaborators
Nicklaus Children's Hospital f/k/a Miami Children's Hospital
Investigators
  • Principal Investigator: Diana Azzam, PhD Florida International University Principal Investigator: Daria Salyakina, PhD Nicklaus Children's Hospital
  • Diana Azzam, PhD Florida International University Principal Investigator: Daria Salyakina, PhD Nicklaus Children's Hospital