NCT03627208

Brief Summary

Background: Acute lymphoblastic leukemia (ALL) is the most common childhood cancer. It occurs when a bone marrow cell develops errors in its DNA. Certain tests are used to help detect the disease. But the results of these tests often disagree. Researchers want to review the results of tests of bone marrow and cerebrospinal fluid (CSF) from people with ALL. They want to try to find the best ways to detect the disease. Objective: To compare results of certain bone marrow and CSF tests for detecting ALL, in order to see how much and how often the results disagreed. Eligibility: Children and young adults with ALL or lymphoblastic lymphoma who were enrolled in certain previous studies and consented for their data to be used. Design: Investigators will review participants medical records. They will collect data like the participant s gender, age, and when their tests were done. They will also collect results from tests like: Bone marrow tests Flow cytometry tests Imaging CSF cell count All of the stored data will be labeled by a code that only the study team at the research site can link to the participant. Data will be stored in password protected computers. ...

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 2, 2018

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

August 8, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 13, 2018

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 14, 2022

Completed
Last Updated

June 1, 2022

Status Verified

May 1, 2022

Enrollment Period

3.4 years

First QC Date

August 8, 2018

Last Update Submit

May 27, 2022

Conditions

Leukemia, Lymphoblastic, AcuteALL, Childhood

Keywords

LYMPHOBLASTIC LYMPHOMAMinimal Residual DiseaseChildhood AllB-Cell MalignanciesNatural History

Outcome Measures

Primary Outcomes (4)

  • To identify the frequency and degree of disease discrepancies in identification of bone marrow involvement by ALL when comparing bone marrow biopsy to bone marrow aspirate to flow cytometric disease detection.

    To identify the frequency and degree of disease discrepancies in identification of bone marrow involvement by ALL when comparing bone marrow biopsy to bone marrow aspirate to flow cytometric disease detection.

    1 year

  • To identify the frequency of discrepancies in identification of CNS involvement by leukemia when comparing flow cytometry to cytopathology.

    To identify the frequency of discrepancies in identification of CNS involvement by leukemia when comparing flow cytometry to cytopathology.

    1 year

  • To identify and characterize immunophenotypic changes in leukemic cells over time and in response to targeted therapy.

    To identify and characterize immunophenotypic changes in leukemic cells over time and in response to targeted therapy.

    1 year

  • To comprehensively characterize EM disease including incidence, presentation, risk factors for and radiographic presentation of disease.

    To comprehensively characterize EM disease including incidence, presentation, risk factors for and radiographic presentation of disease.

    1 year

Study Arms (1)

1

Retrospective chart review of children and young adults with ALL/LBL enrolled on treatment protocols in the POB

Eligibility Criteria

Age2 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children and young adults with ALL/LBL enrolled on treatment protocols in the POB.@@@

You may qualify if:

  • Subjects with ALL or LBL enrolled in any of the source protocols:
  • C-0037, 08-C-0123, 10-C-0220, 11-C-0073, 12-C-0112, 14-C-0175, 15-C-0029, 18-C-0059

You may not qualify if:

  • Patients who opted out of storage of specimens/data for future use on prior studies will be excluded from this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Institute (NCI)

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-LymphomaNeoplasm, Residual

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Nirali N Shah, M.D.

    National Cancer Institute (NCI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2018

First Posted

August 13, 2018

Study Start

August 2, 2018

Primary Completion

December 31, 2021

Study Completion

April 14, 2022

Last Updated

June 1, 2022

Record last verified: 2022-05

Locations

US(1)