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| Name | Class |
|---|---|
| McDonnell Center | UNKNOWN |
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This is a prospective specimen collection study evaluating the feasibility of using the ChromoSeq® assay for upfront classification in a real-time clinical setting of pediatric and young adult acute lymphoid leukemia (ALL) patients. Sixty patients will undergo collections of bone marrow and/or peripheral blood for the ChromoSeq® assay at time of initial workup, and the patients will then be followed for clinical outcomes for up to 65 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Child and Young Adult acute lymphoid leukemia (ALL) patients | At time of initial workup, patients will undergo bone marrow and/or peripheral blood collection for ChromoSeq® (requires 1 mL of peripheral blood or bone marrow aspirate). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ChromoSeq® assay testing | Device | Bone marrow and/or peripheral blood sample will be collected and ChromoSeq® assay testing will be completed. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of success of ChromoSeq® | ChromoSeq® will be successful if the results on the first attempt in a real-time, clinical setting identifies recurrent structural variants and copy number alterations of conventional cytogenetics and karyotype. The success rate and the 95% confidence interval will be calculated. | Time of specimen collection to completion of results (total estimated time is 15 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of time-to-results of ChromoSeq® and conventional cytogenetics | The proportion of results return within 15 days and the 95% confidence interval will be calculated. | Time of specimen collection to 15 days after collection (total estimated time is 15 days) |
| Frequency of mismatch between LDA standard testing and ChromoSeq® defined Ph-like patients. |
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Eligibility Criteria
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Child and young adult patients diagnosed with acute lymphoid leukemia (ALL) seen at St. Louis Children's Hospital/Washington University School of Medicine.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Margaret Ferris, MD, PhD | Contact | 314-454-6018 | youngm@wustl.edu |
| Name | Affiliation | Role |
|---|---|---|
| Margaret Ferris, MD, PhD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine/St. Louis Children's Hospital | Recruiting | St Louis | Missouri | 63110 | United States |
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| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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All of the individual participant data collected during the trial, after de-identification.
Immediately following publication. No end date.
Data will be uploaded to dbGaP.
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| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D054218 | Precursor T-Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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Bone marrow aspirate specimen and/or 1 mL of peripheral blood collection will be collected.
The outcome will be measured by determining the correlation of LDA testing on patients with neutral cytogenetics versus LDA testing on patients whose ChromoSeq® results display a Ph-like translocation for validation. |
| Time of specimen collection to completion of LDA testing (total estimated time is 15 days) |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |