Status:
COMPLETED
Tumor Rebiopsy in Children and Adolescents With Recurrent or Progressive Solid Malignancies
Lead Sponsor:
St. Jude Children's Research Hospital
Conditions:
Tumor, Solid
Eligibility:
All Genders
2-21 years
Brief Summary
It has been shown that the genomic landscape of tumors can dramatically change at the time of disease progression. This suggests that therapies aimed at treating the tumor at diagnosis may not be rele...
Detailed Description
This is a prospective, non-therapeutic study with two components: biopsy of tumor for genomic studies and prospective assessment of parental factors related to participation. All patients at St. Jude ...
Eligibility Criteria
Inclusion
- Age 2-21 years
- Patient has been diagnosed with a solid tumor malignancy that is recurrent or progressive and for whom there is no fresh tumor specimen available.
- Availability of gross disease amenable to biopsy.
- Karnofsky ≥ 50% for patients \>16 years of age and Lansky ≥ 50 for patients ≤ 16 years of age.
Exclusion
- Diagnosis of a non-solid tumor malignancy.
- Patient with known coagulopathy that requires replacement therapy.
- Patient with anesthesia risk that would place the patient at a higher than expected risk for complications (ASA PS4 and ASA PS5).
- Karnofsky or Lansky performance score of \< 50.
- BMI for age \> 95th percentile.
- Refusal or inability to provide written informed consent according to institutional guidelines.
Key Trial Info
Start Date :
December 13 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 31 2019
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT03276702
Start Date
December 13 2017
End Date
July 31 2019
Last Update
June 6 2023
Active Locations (1)
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1
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105