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CompletedNCT00898079Updated Jul 19, 2018

Collecting and Storing Malignant, Borderline Malignant Neoplasms, and Related Samples From Young Patients With Cancer

An observational study in Acute Undifferentiated Leukemia, Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative and Childhood Acute Lymphoblastic Leukemia, sponsored by Children's Oncology Group. Completed at 192 sites in 6 countries. Open to participants aged Up to 30 Years. Per ClinicalTrials.gov, last updated 2018-07-19.

Sponsored by Children's Oncology Group · Observational

Study type
Observational
Enrollment
2,545
Ages
Up to 30 Years
Sex
All
01

Study summary

This study is collecting and storing malignant, borderline malignant neoplasms, and related biological samples from young patients with cancer. Collecting and storing samples of tumor tissue, blood, and bone marrow from patients with cancer to study in the laboratory may help the study of cancer in the future.

Read the detailed description

OBJECTIVES:

I. Collect malignant, borderline malignant neoplasms, and related biological specimens from Children's Oncology Group institutions for cases in which there is no disease-specific biologic protocol.

II. Provide a repository for long-term storage of malignant, borderline malignant neoplasms, and related biological specimens from these patients.

III. Make specimens available to qualified researchers to understand the biology of cancer in these patients.

OUTLINE:

Tumor tissue samples, blood, and bone marrow aspirates are collected and stored for future analysis.

02

Conditions studied

  • Acute Undifferentiated Leukemia
  • Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative
  • Childhood Acute Lymphoblastic Leukemia
  • Childhood Acute Myeloid Leukemia
  • Childhood Chronic Myelogenous Leukemia, BCR-ABL1 Positive
  • Childhood Solid Neoplasm
  • Chronic Lymphocytic Leukemia
  • Hairy Cell Leukemia
  • Juvenile Myelomonocytic Leukemia
  • Mast Cell Leukemia
  • Neoplasm of Uncertain Malignant Potential
  • Prolymphocytic Leukemia
  • Secondary Acute Myeloid Leukemia
  • T-Cell Large Granular Lymphocyte Leukemia
03

In context

Leukemia, Biphenotypic, Acute

117 studies on the registry are indexed under Leukemia, Biphenotypic, Acute; 51 are open to participants now.

Browse Leukemia, Biphenotypic, Acute studies →

Lead sponsor

Children's Oncology Group is the lead sponsor of 447 studies on the registry; 35 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 11 (92%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 30 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Eligibility criteria

Inclusion Criteria:

  • Meets any of the following criteria:

    • Diagnosed with primary neoplasm
    • Developed a second malignant neoplasm
    • Any diagnoses having an ICD-O Morphology Code ending in 1, 2, or 3 as listed in the International Classification of Disease for Oncology, Third Edition
  • Must have biological specimens including solid tumors and leukemias available

    • Solid tumors meeting the following criteria:

      • Snap frozen primary tumor OR OCT embedded primary tumor OR formalin fixed (block or tissue in formalin) primary tumor AND at least 10 unstained paraffin slides for NIH Mandated QC (tumors that have undergone central pathology review are allowed)

        • Slides for pathology review (instead of slides for QC) are required for patients with rare tumors
    • Pleural fluid or cytologic specimens meeting the following criteria:

      • At least 1 mL of fluid and at least 2 unstained cytospin slides (or 2 unstained smears)

        • Slides for pathology review (instead of slides for QC) are required for patients with rare tumors
    • ALL/AML

      • 3-6 mL of bone marrow aspirate and 10 mL of whole blood
  • Not eligible for disease-specific biology or banking protocol
05

Study design

Enrollment
2,545 participants (actual)

Groups and cohorts

  • Observational

    Tumor tissue samples, blood, and bone marrow aspirates are collected and stored for future analysis.

    Other: Cytology Specimen Collection Procedure

Interventions

  • OtherCytology Specimen Collection Procedure

    Correlative studies

    Also known as: Cytologic Sampling

06

What researchers measure

Primary outcomes

  1. Repository of malignant, borderline malignant neoplasms, and related biological specimens

    Time frame: Baseline

07

Study locations

192 sites
  • Children's Hospital of Alabama
    Birmingham, Alabama 35233, United States
  • University of Alabama at Birmingham Cancer Center
    Birmingham, Alabama 35233, United States
  • Phoenix Childrens Hospital
    Phoenix, Arizona 85016, United States
  • Arkansas Children's Hospital
    Little Rock, Arkansas 72202-3591, United States
  • University of Arkansas for Medical Sciences
    Little Rock, Arkansas 72205, United States
  • Kaiser Permanente Downey Medical Center
    Downey, California 90242, United States
  • City of Hope Comprehensive Cancer Center
    Duarte, California 91010, United States
  • Loma Linda University Medical Center
    Loma Linda, California 92354, United States
  • Miller Children's and Women's Hospital Long Beach
    Long Beach, California 90806, United States
  • Children's Hospital Los Angeles
    Los Angeles, California 90027, United States
  • Cedars Sinai Medical Center
    Los Angeles, California 90048, United States
  • Mattel Children's Hospital UCLA
    Los Angeles, California 90095, United States
  • UCLA / Jonsson Comprehensive Cancer Center
    Los Angeles, California 90095, United States
  • Children's Hospital Central California
    Madera, California 93636-8762, United States
  • Children's Hospital and Research Center at Oakland
    Oakland, California 94609-1809, United States
  • Kaiser Permanente-Oakland
    Oakland, California 94611, United States
  • Children's Hospital of Orange County
    Orange, California 92868, United States
  • Lucile Packard Children's Hospital Stanford University
    Palo Alto, California 94304, United States
  • Rady Children's Hospital - San Diego
    San Diego, California 92123, United States
  • UCSF Medical Center-Parnassus
    San Francisco, California 94143, United States
  • UCSF Medical Center-Mission Bay
    San Francisco, California 94158, United States
  • Children's Hospital Colorado
    Aurora, Colorado 80045, United States
  • Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
    Denver, Colorado 80218, United States
  • Connecticut Children's Medical Center
    Hartford, Connecticut 06106, United States
  • Alfred I duPont Hospital for Children
    Wilmington, Delaware 19803, United States
  • MedStar Georgetown University Hospital
    Washington D.C., District of Columbia 20007, United States
  • Children's National Medical Center
    Washington D.C., District of Columbia 20010, United States
  • Broward Health Medical Center
    Fort Lauderdale, Florida 33316, United States
  • Lee Memorial Health System
    Fort Myers, Florida 33901, United States
  • Golisano Children's Hospital of Southwest Florida
    Fort Myers, Florida 33908, United States
  • University of Florida Health Science Center - Gainesville
    Gainesville, Florida 32610, United States
  • Memorial Regional Hospital/Joe DiMaggio Children's Hospital
    Hollywood, Florida 33021, United States
  • Nemours Children's Clinic-Jacksonville
    Jacksonville, Florida 32207, United States
  • University of Miami Miller School of Medicine-Sylvester Cancer Center
    Miami, Florida 33136, United States
  • Nicklaus Children's Hospital
    Miami, Florida 33155, United States
  • Miami Cancer Institute
    Miami, Florida 33176, United States
  • Florida Hospital Orlando
    Orlando, Florida 32803, United States
  • Nemours Children's Clinic - Orlando
    Orlando, Florida 32806, United States
  • Nemours Children's Hospital
    Orlando, Florida 32827, United States
  • Nemours Children's Clinic - Pensacola
    Pensacola, Florida 32504, United States
  • Johns Hopkins All Children's Hospital
    St. Petersburg, Florida 33701, United States
  • Tampa General Hospital
    Tampa, Florida 33606, United States
  • Saint Joseph's Hospital/Children's Hospital-Tampa
    Tampa, Florida 33607, United States
  • Saint Mary's Hospital
    West Palm Beach, Florida 33407, United States
  • Children's Healthcare of Atlanta - Egleston
    Atlanta, Georgia 30322, United States
  • Memorial Health University Medical Center
    Savannah, Georgia 31404, United States
  • University of Hawaii Cancer Center
    Honolulu, Hawaii 96813, United States
  • Kapiolani Medical Center for Women and Children
    Honolulu, Hawaii 96826, United States
  • Saint Luke's Mountain States Tumor Institute
    Boise, Idaho 83712, United States
  • Lurie Children's Hospital-Chicago
    Chicago, Illinois 60611, United States
  • University of Illinois
    Chicago, Illinois 60612, United States
  • University of Chicago Comprehensive Cancer Center
    Chicago, Illinois 60637, United States
  • Loyola University Medical Center
    Maywood, Illinois 60153, United States
  • Advocate Children's Hospital-Park Ridge
    Park Ridge, Illinois 60068, United States
  • Advocate Lutheran General Hospital
    Park Ridge, Illinois 60068, United States
  • Saint Jude Midwest Affiliate
    Peoria, Illinois 61637, United States
  • Southern Illinois University School of Medicine
    Springfield, Illinois 62702, United States
  • Riley Hospital for Children
    Indianapolis, Indiana 46202, United States
  • Saint Vincent Hospital and Health Care Center
    Indianapolis, Indiana 46260, United States
  • Blank Children's Hospital
    Des Moines, Iowa 50309, United States
  • University of Iowa/Holden Comprehensive Cancer Center
    Iowa City, Iowa 52242, United States
  • University of Kansas Cancer Center
    Kansas City, Kansas 66160, United States
  • University of Kentucky/Markey Cancer Center
    Lexington, Kentucky 40536, United States
  • Norton Children's Hospital
    Louisville, Kentucky 40202, United States
  • Tulane University Health Sciences Center
    New Orleans, Louisiana 70112, United States
  • Children's Hospital New Orleans
    New Orleans, Louisiana 70118, United States
  • Ochsner Medical Center Jefferson
    New Orleans, Louisiana 70121, United States
  • Maine Children's Cancer Program
    Scarborough, Maine 04074, United States
  • Sinai Hospital of Baltimore
    Baltimore, Maryland 21215, United States
  • Walter Reed National Military Medical Center
    Bethesda, Maryland 20889-5600, United States
  • Dana-Farber Cancer Institute
    Boston, Massachusetts 02215, United States
  • Baystate Medical Center
    Springfield, Massachusetts 01199, United States
  • C S Mott Children's Hospital
    Ann Arbor, Michigan 48109, United States
  • Wayne State University/Karmanos Cancer Institute
    Detroit, Michigan 48201, United States
  • Saint John Hospital and Medical Center
    Detroit, Michigan 48236, United States
  • Michigan State University Clinical Center
    East Lansing, Michigan 48824-7016, United States
  • Hurley Medical Center
    Flint, Michigan 48503, United States
  • Helen DeVos Children's Hospital at Spectrum Health
    Grand Rapids, Michigan 49503, United States
  • Bronson Methodist Hospital
    Kalamazoo, Michigan 49007, United States
  • Kalamazoo Center for Medical Studies
    Kalamazoo, Michigan 49008, United States
  • Children's Hospitals and Clinics of Minnesota - Minneapolis
    Minneapolis, Minnesota 55404, United States
  • University of Minnesota/Masonic Cancer Center
    Minneapolis, Minnesota 55455, United States
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
  • University of Mississippi Medical Center
    Jackson, Mississippi 39216, United States
  • Columbia Regional
    Columbia, Missouri 65201, United States
  • The Childrens Mercy Hospital
    Kansas City, Missouri 64108, United States
  • Cardinal Glennon Children's Medical Center
    St Louis, Missouri 63104, United States
  • Washington University School of Medicine
    St Louis, Missouri 63110, United States
  • Children's Hospital and Medical Center of Omaha
    Omaha, Nebraska 68114, United States
  • University of Nebraska Medical Center
    Omaha, Nebraska 68198, United States
  • Nevada Cancer Research Foundation CCOP
    Las Vegas, Nevada 89106, United States
  • Children's Specialty Center of Nevada II
    Las Vegas, Nevada 89109, United States
  • Sunrise Hospital and Medical Center
    Las Vegas, Nevada 89109, United States
  • Hackensack University Medical Center
    Hackensack, New Jersey 07601, United States
  • Saint Barnabas Medical Center
    Livingston, New Jersey 07039, United States
  • Morristown Medical Center
    Morristown, New Jersey 07960, United States
  • Saint Peter's University Hospital
    New Brunswick, New Jersey 08901, United States
  • Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
    New Brunswick, New Jersey 08903, United States
  • Newark Beth Israel Medical Center
    Newark, New Jersey 07112, United States
  • Saint Joseph's Regional Medical Center
    Paterson, New Jersey 07503, United States

Showing the first 100 of 192 sites across 6 countries.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 19, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00898079
Responsible party
Sponsor
First posted
May 12, 2009
Start date
Oct 13, 2003
Primary completion
Jun 30, 2018
Completion
Jun 30, 2018
Last update
Jul 19, 2018

Study contacts

Nilsa Ramirez
principal investigator · Children's Oncology Group
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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