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A Protocol for Prospectively Collecting Fresh Tumor Tissue in Children and Adolescents With Recurrent or Progressive Solid Malignancies
Sponsor study identifier
observational
8
1 country
1
Study Start
December 13, 2017
Actual (reported)Primary Completion
July 31, 2019
Actual (reported)Study Completion
July 31, 2019
Actual (reported)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 relevant at the time of relapse. Obtaining fresh tissue at the time of relapse could facilitate the identification of potential targets that have developed through mutational evolution of the primary tumor and would provide an unprecedented opportunity to expand the library of patient derived xenografts (PDX) that are available for comprehensive preclinical testing in the setting of relapsed disease. The purpose of this observational study is to prospectively collect fresh tumor tissue from pediatric patients with solid tumors who have recurrent or progressive disease and submit this tissue for comprehensive genomic analysis using clinically available CLIA-certified platforms that include WGS, WES and RNAseq, and to assess the reasons for a patient and/or a parent for making a decision to proceed with or refuse a re-biopsy procedure in the presence of a recurrent or progressive solid tumor. The data obtained will be used to develop new novel therapies that incorporate new pharmacological agents in pediatric solid tumors. PRIMARY OBJECTIVES:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 31, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 7, 2017
Actual (reported)September 8, 2017
Actual (reported)December 13, 2017
Actual (reported)July 31, 2019
Actual (reported)July 31, 2019
Actual (reported)Percent of good quality tumor samples obtained
Good quality of the sampled tumor is defined as greater than 50% viable tumor from which at least 2 µg DNA and 1 µg RNA can be extracted.
Once at study enrollment
St. Jude Children's Research Hospital patients with relapsed or progressive solid tumor will be asked to complete a questionnaire on two occasions and optional re-biopsy of tumor tissue.
For those participants who agree, a biopsy of their tumor to obtain tissue for genetic analysis will be done at the time of relapse or disease progression.
Parents or patients will be asked to complete a questionnaire to assess the impact and perception of an optional/research only biopsy. A second questionnaire will be administered approximately 4-8 weeks after biopsy to assess decisional regret.
St. Jude Children's Research Hospital patient with a solid tumor malignancy that is progressive or recurrent.
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105, United States
DNA will be extracted from the patient's peripheral blood and tumor samples and RNA will be extracted from the tumor sample and whole genome sequencing (WGS), whole exome sequencing (WES) and transcriptome sequencing (RNA-Seq) will be performed on Illumina Next Generation Sequencers. Both somatic and germline variants (single nucleotide variants, structural variants, insertions/deletions, and copy number variants) will be identified using a bioinformatics pipeline developed and validated at SJCRH. Separate reports will be generated for the somatic lesions and germline lesions. In the event that there is not enough fresh tissue to perform WGS, WES and RNAseq will be performed in FFPE material if available.
Alberto Pappo, MD
St. Jude Children's Research Hospital
8 participants (actual enrollment reported by the registry).
First Submitted
September 7, 2017
First Posted
September 8, 2017
Study Start
December 13, 2017
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
July 31, 2019
Actual (reported)Study Completion
July 31, 2019
Actual (reported)Last Updated
June 6, 2023
Record last verified: 2023-06
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Source: ClinicalTrials.gov.
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