TriangleNCT03155620 · STUDY IN CONTEXT
Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The
Draft scope assessment: unclear. Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
A descriptive analysis will be performed and will be summarized with simple summary statistics. This analysis will be descriptive in nature.
A descriptive analysis will be performed and will be summarized with simple summary statistics. This analysis will be descriptive in nature.
Will be evaluated through circulating tumor deoxyribonucleic acid (DNA). A descriptive analysis will be performed and will be summarized with simple summary statistics. This analysis will be descriptive in nature.
A descriptive analysis will be performed and will be summarized with simple summary statistics. This analysis will be descriptive in nature. Will assess the feasibility of return of the results in the National Clinical Trial Network (NCTN) group setting.
Match rate will be calculated as the percent of eligible patients who have an actionable mutation of interest and are matched to at least one of the subprotocols, and confidence intervals will be constructed using the Wilson score interval method. Patients enrolled on or after Amendment 4 will not be included in this analysis as screening of unselected patients will no longer be conducted.
Response rates will be calculated as the percent of evaluable patients who are responders, and confidence intervals will be constructed using the Wilson score interval method.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-rhabdomyosarcoma-pediatric-metastatic-52b6210d
- nct id
- NCT03155620
- trial label
- Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The
- applicability
- unclear
- applicability note
- Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 6
- harms Count
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-rhabdomyosarcoma-pediatric-metastatic-52b6210d
- nct id
- NCT03155620
- outcome key
- om-0002
- source section id
- NCT03155620-om-0002
- source outcome index
- 2
- endpoint
- Genomic Landscape of Advanced Pediatric Solid Tumors, Non-Hodgkin Lymphomas, and Histiocytic Disorders
- endpoint definition
- A descriptive analysis will be performed and will be summarized with simple summary statistics. This analysis will be descriptive in nature.
- time origin
- Up to 4 years
- analysis role
- exploratory
- reporting status
- NOT_POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-rhabdomyosarcoma-pediatric-metastatic-52b6210d
- nct id
- NCT03155620
- outcome key
- om-0003
- source section id
- NCT03155620-om-0003
- source outcome index
- 3
- endpoint
- Change in Genomics in Advanced Pediatric Cancers
- endpoint definition
- A descriptive analysis will be performed and will be summarized with simple summary statistics. This analysis will be descriptive in nature.
- time origin
- Baseline up to 4 years
- analysis role
- exploratory
- reporting status
- NOT_POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-rhabdomyosarcoma-pediatric-metastatic-52b6210d
- nct id
- NCT03155620
- outcome key
- om-0004
- source section id
- NCT03155620-om-0004
- source outcome index
- 4
- endpoint
- Diagnostic and Profiling Genomics of Tumor Approach
- endpoint definition
- Will be evaluated through circulating tumor deoxyribonucleic acid (DNA). A descriptive analysis will be performed and will be summarized with simple summary statistics. This analysis will be descriptive in nature.
- time origin
- Up to 4 years
- analysis role
- exploratory
- reporting status
- NOT_POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-rhabdomyosarcoma-pediatric-metastatic-52b6210d
- nct id
- NCT03155620
- outcome key
- om-0005
- source section id
- NCT03155620-om-0005
- source outcome index
- 5
- endpoint
- Frequency of Germline Cancer Susceptibility Mutations in Children With Relapsed Solid Tumors and Non-Hodgkin Lymphomas
- endpoint definition
- A descriptive analysis will be performed and will be summarized with simple summary statistics. This analysis will be descriptive in nature. Will assess the feasibility of return of the results in the National Clinical Trial Network (NCTN) group setting.
- time origin
- Up to 4 years
- analysis role
- exploratory
- reporting status
- NOT_POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-rhabdomyosarcoma-pediatric-metastatic-52b6210d
- nct id
- NCT03155620
- outcome key
- om-0000
- source section id
- NCT03155620-om-0000
- source outcome index
- 0
- endpoint
- Proportion of Pediatric Patients Whose Advanced Tumors Have Pathway Alterations That Can be Targeted by Select Anti-cancer Drugs
- endpoint definition
- Match rate will be calculated as the percent of eligible patients who have an actionable mutation of interest and are matched to at least one of the subprotocols, and confidence intervals will be constructed using the Wilson score interval method. Patients enrolled on or after Amendment 4 will not be included in this analysis as screening of unselected patients will no longer be conducted.
- time origin
- Up to 2 years from study entry
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Patients enrolled after Amendment 4 are not included in this analysis
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-rhabdomyosarcoma-pediatric-metastatic-52b6210d
- nct id
- NCT03155620
- outcome key
- om-0001
- source section id
- NCT03155620-om-0001
- source outcome index
- 1
- endpoint
- Objective Response Rate (ORR) to Targeted Therapy in Tumors Lacking Actionable Alterations
- endpoint definition
- Response rates will be calculated as the percent of evaluable patients who are responders, and confidence intervals will be constructed using the Wilson score interval method.
- time origin
- Up to 2 years from study entry
- analysis role
- secondary
- reporting status
- NOT_POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-rhabdomyosarcoma-pediatric-metastatic-52b6210d
- nct id
- NCT03155620
- outcome key
- om-0000
- arm key
- OG000
- arm label
- NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) Screening Protocol
- regimen
- Patients undergo biopsy along with tumor mutational screening of the biopsy material for specific, pre-defined mutations, amplifications, or translocations of interest via tumor sequencing and immunohistochemistry. Patients also undergo collection of blood samples for research purposes.
- analyzed count
- 1158
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03155620-om-0000#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-rhabdomyosarcoma-pediatric-metastatic-52b6210d
- nct id
- NCT03155620
- harm key
- EG000
- source section id
- NCT03155620-ae
- event group key
- EG000
- event group label
- NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) Screening Protocol
- serious affected
- 2
- serious at risk
- 1343
- other affected
- 1
- other at risk
- 1343
- frequency threshold
- 0
- collection period
- The reporting timeframe includes adverse events occurring within 14 days following a biopsy performed after enrollment on this study. All-Cause Mortality monitored/assessed up to 5 years.
- event definition
- Biopsy related AE reporting is collected routinely using case report forms. The SAE table reflects biopsy related CTCAEs submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining biopsy related CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients enrolled after Stage 1 (12/31/21) are excluded from AE reporting. All-Cause Mortality includes all deaths collected on the study for enrolled patients.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice