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Umbrella Long-Term Follow-Up Protocol


N/A
N/A
N/A
Open (Enrolling)
Both
Accelerated Phase Chronic Myelogenous Leukemia, Acute Myeloid Leukemia/Transient Myeloproliferative Disorder, Acute Undifferentiated Leukemia, Angioimmunoblastic T-cell Lymphoma, Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative, Blastic Phase Chronic Myelogenous Leukemia, Childhood Acute Lymphoblastic Leukemia in Remission, Childhood Acute Myeloid Leukemia in Remission, Childhood Burkitt Lymphoma, Childhood Chronic Myelogenous Leukemia, Childhood Diffuse Large Cell Lymphoma, Childhood Grade III Lymphomatoid Granulomatosis, Childhood Immunoblastic Large Cell Lymphoma, Childhood Myelodysplastic Syndromes, Childhood Nasal Type Extranodal NK/T-cell Lymphoma, Chronic Eosinophilic Leukemia, Chronic Myelomonocytic Leukemia, Chronic Neutrophilic Leukemia, Chronic Phase Chronic Myelogenous Leukemia, Cutaneous B-cell Non-Hodgkin Lymphoma, Essential Thrombocythemia, Extramedullary Plasmacytoma, Intraocular Lymphoma, Isolated Plasmacytoma of Bone, Juvenile Myelomonocytic Leukemia, Long-term Effects Secondary to Cancer Therapy in Children, Mast Cell Leukemia, Meningeal Chronic Myelogenous Leukemia, Monoclonal Gammopathy of Undetermined Significance, Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable, Polycythemia Vera, Post-transplant Lymphoproliferative Disorder, Primary Central Nervous System Hodgkin Lymphoma, Primary Central Nervous System Non-Hodgkin Lymphoma, Primary Myelofibrosis, Primary Systemic Amyloidosis, Progressive Hairy Cell Leukemia, Initial Treatment, Prolymphocytic Leukemia, Secondary Acute Myeloid Leukemia, Secondary Myelodysplastic Syndromes, Stage 0 Chronic Lymphocytic Leukemia, Stage I Childhood Anaplastic Large Cell Lymphoma, Stage I Childhood Hodgkin Lymphoma, Stage I Childhood Large Cell Lymphoma, Stage I Childhood Lymphoblastic Lymphoma, Stage I Childhood Small Noncleaved Cell Lymphoma, Stage I Chronic Lymphocytic Leukemia, Stage I Cutaneous T-cell Non-Hodgkin Lymphoma, Stage I Multiple Myeloma, Stage I Mycosis Fungoides/Sezary Syndrome, Stage II Childhood Anaplastic Large Cell Lymphoma, Stage II Childhood Hodgkin Lymphoma, Stage II Childhood Large Cell Lymphoma, Stage II Childhood Lymphoblastic Lymphoma, Stage II Childhood Small Noncleaved Cell Lymphoma, Stage II Chronic Lymphocytic Leukemia, Stage II Cutaneous T-cell Non-Hodgkin Lymphoma, Stage II Multiple Myeloma, Stage II Mycosis Fungoides/Sezary Syndrome, Stage III Childhood Anaplastic Large Cell Lymphoma, Stage III Childhood Hodgkin Lymphoma, Stage III Childhood Large Cell Lymphoma, Stage III Childhood Lymphoblastic Lymphoma, Stage III Childhood Small Noncleaved Cell Lymphoma, Stage III Chronic Lymphocytic Leukemia, Stage III Cutaneous T-cell Non-Hodgkin Lymphoma, Stage III Multiple Myeloma, Stage III Mycosis Fungoides/Sezary Syndrome, Stage IV Childhood Anaplastic Large Cell Lymphoma, Stage IV Childhood Hodgkin Lymphoma, Stage IV Childhood Large Cell Lymphoma, Stage IV Childhood Lymphoblastic Lymphoma, Stage IV Childhood Small Noncleaved Cell Lymphoma, Stage IV Chronic Lymphocytic Leukemia, Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma, Stage IV Mycosis Fungoides/Sezary Syndrome, T-cell Large Granular Lymphocyte Leukemia, Unspecified Childhood Solid Tumor, Protocol Specific, Untreated Childhood Acute Lymphoblastic Leukemia, Untreated Childhood Acute Myeloid Leukemia and Other Myeloid Malignancies, Untreated Hairy Cell Leukemia, Waldenström Macroglobulinemia

Thank you

Trial Information

Umbrella Long-Term Follow-Up Protocol


OBJECTIVES:

I. To develop a mechanism for tracking and retaining patients enrolled on COG protocols.

II. To maintain regular, lifetime contact with patients in order to obtain current
identification and contact information, and self/parent-reported health status.

III. To locate patients who are lost-to-follow-up for COG (or Legacy Group) protocols
targeted for follow-up by the Long-Term Follow-Up Center (LTFC).

IV. To provide current patient contact information and self/parent-reported health status
updates to the COG Statistics and Data Center (SDC) and to each patient's COG institution.

V. To facilitate collection of protocol-specific outcome data through collaboration with the
COG Late Effects Committee, the SDC, and the member institutions.

VI. To collect cumulative therapeutic exposure data (via therapeutic summaries completed
online by treating institutions) on patients completing active therapy.

OUTLINE: This is an umbrella protocol for all long-term follow-up at COG institutions.

Approximately 6 months after completion of therapy patients receive a mailed packet
introducing the Long-Term Follow-Up Center (LTFC) and containing information related to
their individualized, protocol-specific follow-up guidelines. Patients are asked to complete
a patient response form, verify information provided in packet, update contact information,
and complete a Health Status Update Form. The Health Status Update Form is a brief document
including questions about current health status, disease status, and cancer therapy received
since the last mailing. Patients receive protocol-specific automatic reminders, and may
respond by use of postage prepaid envelopes, email, or 24-hour toll-free telephone.


Inclusion Criteria:



- Must be newly diagnosed with a primary malignancy and enrolled on a front line COG
therapeutic trial for treatment of a primary malignancy OR must have been enrolled on
a COG (or Legacy Group) therapeutic or non-therapeutic trial calling for long-term
follow-up, including any of the following:

- Hodgkin lymphoma

- CCG-5942

- POG-9425

- POG-9426

- COG-AHOD0031

- Brain tumor

- CCG-A9961

- Acute lymphoblastic leukemia

- COG-ALTE02C2

- Neuroblastoma

- COG-A3973

- Rhabdomyosarcoma

- IRS-III

- IRS-IV-Stage 1

- IRS-IV-Stage 2/3

- IRS-IV-Stage/Group 4

- Must reside in the U.S. during trial enrollment

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Outcome Measure:

Development of mechanism for tracking and retaining patients enrolled on COG protocols

Outcome Time Frame:

Not Provided

Safety Issue:

No

Principal Investigator

Smita Bhatia

Investigator Role:

Principal Investigator

Investigator Affiliation:

Children's Oncology Group

Authority:

United States: Institutional Review Board

Study ID:

ALTE05N1

NCT ID:

NCT00736749

Start Date:

May 2008

Completion Date:

Related Keywords:

  • Accelerated Phase Chronic Myelogenous Leukemia
  • Acute Myeloid Leukemia/Transient Myeloproliferative Disorder
  • Acute Undifferentiated Leukemia
  • Angioimmunoblastic T-cell Lymphoma
  • Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative
  • Blastic Phase Chronic Myelogenous Leukemia
  • Childhood Acute Lymphoblastic Leukemia in Remission
  • Childhood Acute Myeloid Leukemia in Remission
  • Childhood Burkitt Lymphoma
  • Childhood Chronic Myelogenous Leukemia
  • Childhood Diffuse Large Cell Lymphoma
  • Childhood Grade III Lymphomatoid Granulomatosis
  • Childhood Immunoblastic Large Cell Lymphoma
  • Childhood Myelodysplastic Syndromes
  • Childhood Nasal Type Extranodal NK/T-cell Lymphoma
  • Chronic Eosinophilic Leukemia
  • Chronic Myelomonocytic Leukemia
  • Chronic Neutrophilic Leukemia
  • Chronic Phase Chronic Myelogenous Leukemia
  • Cutaneous B-cell Non-Hodgkin Lymphoma
  • Essential Thrombocythemia
  • Extramedullary Plasmacytoma
  • Intraocular Lymphoma
  • Isolated Plasmacytoma of Bone
  • Juvenile Myelomonocytic Leukemia
  • Long-term Effects Secondary to Cancer Therapy in Children
  • Mast Cell Leukemia
  • Meningeal Chronic Myelogenous Leukemia
  • Monoclonal Gammopathy of Undetermined Significance
  • Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable
  • Polycythemia Vera
  • Post-transplant Lymphoproliferative Disorder
  • Primary Central Nervous System Hodgkin Lymphoma
  • Primary Central Nervous System Non-Hodgkin Lymphoma
  • Primary Myelofibrosis
  • Primary Systemic Amyloidosis
  • Progressive Hairy Cell Leukemia, Initial Treatment
  • Prolymphocytic Leukemia
  • Secondary Acute Myeloid Leukemia
  • Secondary Myelodysplastic Syndromes
  • Stage 0 Chronic Lymphocytic Leukemia
  • Stage I Childhood Anaplastic Large Cell Lymphoma
  • Stage I Childhood Hodgkin Lymphoma
  • Stage I Childhood Large Cell Lymphoma
  • Stage I Childhood Lymphoblastic Lymphoma
  • Stage I Childhood Small Noncleaved Cell Lymphoma
  • Stage I Chronic Lymphocytic Leukemia
  • Stage I Cutaneous T-cell Non-Hodgkin Lymphoma
  • Stage I Multiple Myeloma
  • Stage I Mycosis Fungoides/Sezary Syndrome
  • Stage II Childhood Anaplastic Large Cell Lymphoma
  • Stage II Childhood Hodgkin Lymphoma
  • Stage II Childhood Large Cell Lymphoma
  • Stage II Childhood Lymphoblastic Lymphoma
  • Stage II Childhood Small Noncleaved Cell Lymphoma
  • Stage II Chronic Lymphocytic Leukemia
  • Stage II Cutaneous T-cell Non-Hodgkin Lymphoma
  • Stage II Multiple Myeloma
  • Stage II Mycosis Fungoides/Sezary Syndrome
  • Stage III Childhood Anaplastic Large Cell Lymphoma
  • Stage III Childhood Hodgkin Lymphoma
  • Stage III Childhood Large Cell Lymphoma
  • Stage III Childhood Lymphoblastic Lymphoma
  • Stage III Childhood Small Noncleaved Cell Lymphoma
  • Stage III Chronic Lymphocytic Leukemia
  • Stage III Cutaneous T-cell Non-Hodgkin Lymphoma
  • Stage III Multiple Myeloma
  • Stage III Mycosis Fungoides/Sezary Syndrome
  • Stage IV Childhood Anaplastic Large Cell Lymphoma
  • Stage IV Childhood Hodgkin Lymphoma
  • Stage IV Childhood Large Cell Lymphoma
  • Stage IV Childhood Lymphoblastic Lymphoma
  • Stage IV Childhood Small Noncleaved Cell Lymphoma
  • Stage IV Chronic Lymphocytic Leukemia
  • Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma
  • Stage IV Mycosis Fungoides/Sezary Syndrome
  • T-cell Large Granular Lymphocyte Leukemia
  • Unspecified Childhood Solid Tumor, Protocol Specific
  • Untreated Childhood Acute Lymphoblastic Leukemia
  • Untreated Childhood Acute Myeloid Leukemia and Other Myeloid Malignancies
  • Untreated Hairy Cell Leukemia
  • Waldenström Macroglobulinemia
  • Primary Myelofibrosis
  • Amyloidosis
  • Blast Crisis
  • Burkitt Lymphoma
  • Neoplasms
  • Hodgkin Disease
  • Immunoblastic Lymphadenopathy
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Hairy Cell
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Mast-Cell
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myeloid, Accelerated Phase
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Leukemia, Myeloid, Chronic-Phase
  • Leukemia, Myelomonocytic, Chronic
  • Leukemia, Neutrophilic, Chronic
  • Leukemia, Prolymphocytic
  • Lymphoma
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Non-Hodgkin
  • Lymphomatoid Granulomatosis
  • Lymphoproliferative Disorders
  • Waldenstrom Macroglobulinemia
  • Monoclonal Gammopathy of Undetermined Significance
  • Paraproteinemias
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Mycoses
  • Mycosis Fungoides
  • Myelodysplastic Syndromes
  • Preleukemia
  • Leukemia, Myelomonocytic, Acute
  • Myeloproliferative Disorders
  • Plasmacytoma
  • Polycythemia
  • Polycythemia Vera
  • Sezary Syndrome
  • Thrombocythemia, Essential
  • Lymphoma, B-Cell
  • Lymphoma, Large-Cell, Immunoblastic
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Cutaneous
  • Hypereosinophilic Syndrome
  • Lymphoma, Large-Cell, Anaplastic
  • Lymphoma, Extranodal NK-T-Cell
  • Leukemia, Myelomonocytic, Juvenile
  • Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative
  • Thrombocytosis
  • Myelodysplastic-Myeloproliferative Diseases
  • Leukemia, Large Granular Lymphocytic

Name

Location

Johns Hopkins University Baltimore, Maryland  21205
Cleveland Clinic Foundation Cleveland, Ohio  44195
Roswell Park Cancer Institute Buffalo, New York  14263
Mayo Clinic Rochester, Minnesota  55905
Children's Hospital of Philadelphia Philadelphia, Pennsylvania  19104
University of Iowa Hospitals and Clinics Iowa City, Iowa  52242
University of Mississippi Medical Center Jackson, Mississippi  39216-4505
Washington University School of Medicine Saint Louis, Missouri  63110
Medical University of South Carolina Charleston, South Carolina  29425-0721
Rhode Island Hospital Providence, Rhode Island  02903
University of Texas Health Science Center at San Antonio San Antonio, Texas  78284-7811
Midwest Children's Cancer Center Milwaukee, Wisconsin  53226
Sinai Hospital of Baltimore Baltimore, Maryland  21225
Vanderbilt-Ingram Cancer Center Nashville, Tennessee  37232-6838
Morristown Memorial Hospital Morristown, New Jersey  07962-1956
Marshfield Clinic Marshfield, Wisconsin  54449
Loma Linda University Medical Center Loma Linda, California  92354
Baptist Hospital of Miami Miami, Florida  33176-2197
Newark Beth Israel Medical Center Newark, New Jersey  07112
New York Medical College Valhalla, New York  10595
Cedars-Sinai Medical Center Los Angeles, California  90048
University of Arkansas for Medical Sciences Little Rock, Arkansas  72205
Hackensack University Medical Center Hackensack, New Jersey  07601
Children's Hospital Los Angeles Los Angeles, California  90027-0700
Children's National Medical Center Washington, District of Columbia  20010-2970
All Children's Hospital St. Petersburg, Florida  33701
Advocate Hope Children's Hospital Oak Lawn, Illinois  60453
Saint Jude Midwest Affiliate Peoria, Illinois  61637
Carolinas Medical Center Charlotte, North Carolina  28232-2861
University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma  73104
St. Jude Children's Research Hospital Memphis, Tennessee  38105-2794
Driscoll Children's Hospital Corpus Christi, Texas  78466
Inova Fairfax Hospital Falls Church, Virginia  22042-3300
Southern California Permanente Medical Group Downey, California  90242
Children's Hospital Central California Madera, California  93638-8762
Kosair Children's Hospital Louisville, Kentucky  40202-3830
Children's Hospital Medical Center of Akron Akron, Ohio  44308
Overlook Hospital Summit, New Jersey  07902-0220
Winthrop University Hospital Mineola, New York  11501
Mount Sinai Medical Center New York, New York  10029
Cincinnati Children's Hospital Medical Center Cincinnati, Ohio  45229-3039
Primary Children's Medical Center Salt Lake City, Utah  84113-1100
Montefiore Medical Center Bronx, New York  10467-2490
Saint Peter's University Hospital New Brunswick, New Jersey  08901-1780
Rady Children's Hospital - San Diego San Diego, California  92123-4282
Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis, Minnesota  55404
University of New Mexico Cancer Center Albuquerque, New Mexico  87131-5636
Nationwide Children's Hospital Columbus, Ohio  43205-2696
Children's Hospital of Pittsburgh of UPMC Pittsburgh, Pennsylvania  15213
Dell Children's Medical Center of Central Texas Austin, Texas  78723
Mary Bridge Children's Hospital and Health Center Tacoma, Washington  98415-0299
City of Hope Medical Center Duarte, California  91010
Presbyterian Hospital Charlotte, North Carolina  28233-3549
Lee Memorial Health System Fort Myers, Florida  33902
University of Alabama at Birmingham Birmingham, Alabama  35294-3300
Children's Hospital of Alabama Birmingham, Alabama  35233
Connecticut Children's Medical Center Hartford, Connecticut  06106
University of North Carolina Chapel Hill, North Carolina  27599
Duke University Medical Center Durham, North Carolina  27710
University of Rochester Rochester, New York  14642
Nemours Children's Clinic - Pensacola Pensacola, Florida  32504
Helen DeVos Children's Hospital at Spectrum Health Grand Rapids, Michigan  49503
Yale University New Haven, Connecticut  06520
Wayne State University Detroit, Michigan  48202
Mercy Children's Hospital Toledo, Ohio  43608
BI-LO Charities Children's Cancer Center Greenville, South Carolina  29605
Dartmouth Hitchcock Medical Center Lebanon, New Hampshire  03756
University Of Vermont Burlington,, Vermont  05403
Albany Medical Center Albany, New York  12208
University of Texas Southwestern Medical Center Dallas, Texas  
University of Kentucky Lexington, Kentucky  40536-0098
UC Davis Comprehensive Cancer Center Sacramento, California  95817
Tulane University Health Sciences Center New Orleans, Louisiana  70112
Virginia Commonwealth University Richmond, Virginia  
David Geffen School of Medicine at UCLA Los Angeles, California  90095
Florida Hospital Orlando, Florida  32803
University of Chicago Comprehensive Cancer Center Chicago, Illinois  60637-1470
Seattle Children's Hospital Seattle, Washington  98105
Wake Forest University Health Sciences Winston-Salem, North Carolina  27157
Childrens Memorial Hospital Chicago, Illinois  60614
Kaiser Permanente-Oakland Oakland, California  94611
Lombardi Comprehensive Cancer Center at Georgetown University Washington, District of Columbia  20057
M D Anderson Cancer Center- Orlando Orlando, Florida  32806
University of Hawaii Honolulu, Hawaii  96813
Saint Luke's Mountain States Tumor Institute Boise, Idaho  83712
Saint Vincent Hospital and Health Services Indianapolis, Indiana  46260
Saint John Hospital and Medical Center Detroit, Michigan  48236
Nevada Cancer Research Foundation CCOP Las Vegas, Nevada  89106
Columbia University Medical Center New York, New York  10032
State University of New York Upstate Medical University Syracuse, New York  13210
Mission Hospitals Inc Asheville, North Carolina  28801
Natalie W Bryant Cancer Center Tulsa, Oklahoma  74136
Saint Vincent Hospital Green Bay, Wisconsin  54301
University of South Alabama Mobile, Alabama  36693
University of Illinois Chicago, Illinois  60612
Cook Children's Medical Center Fort Worth, Texas  76104
East Carolina University Greenville, North Carolina  27858
West Virginia University Charleston Charleston, West Virginia  25304
The Children's Medical Center of Dayton Dayton, Ohio  45404
University of Minnesota Medical Center-Fairview Minneapolis, Minnesota  55455
Children's Oncology Group Arcadia, California  91006-3776
C S Mott Children's Hospital Ann Arbor, Michigan  48109
Southern Illinois University Springfield, Illinois  62702
University Of Missouri-Columbia Columbia, Missouri  65212
Walter Reed National Military Medical Center Bethesda, Maryland  20889
Riley Hospital for Children Indianapolis, Indiana  46202
UMDNJ - Robert Wood Johnson University Hospital New Brunswick, New Jersey  08903
Phoenix Childrens Hospital Phoenix, Arizona  85016
Miller Children's Hospital Long Beach, California  90806
Childrens Hospital of Orange County Orange, California  92868-3874
Alfred I duPont Hospital for Children Wilmington, Delaware  19803
Nemours Children's Clinic - Jacksonville Jacksonville, Florida  32207-8426
Nemours Childrens Clinic - Orlando Orlando, Florida  32806
Saint Joseph Children's Hospital of Tampa Tampa, Florida  33607
Children's Healthcare of Atlanta - Egleston Atlanta, Georgia  30322
The Childrens Mercy Hospital Kansas City, Missouri  64108
Rainbow Babies and Childrens Hospital Cleveland, Ohio  44106
Penn State Hershey Children's Hospital Hershey, Pennsylvania  17033
Palmetto Health Richland Columbia, South Carolina  29203
East Tennessee Childrens Hospital Knoxville, Tennessee  37916
Saint Joseph's Regional Medical Center Paterson, New Jersey  07503
Sanford Medical Center-Fargo Fargo, North Dakota  58122
Children's Hospital Colorado Aurora, Colorado  80045
Floating Hospital for Children at Tufts Medical Center Boston, Massachusetts  02111
Lucile Packard Children's Hospital Stanford University Palo Alto, California  94304
University of California San Francisco Medical Center-Parnassus San Francisco, California  94143
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Denver, Colorado  80218
Raymond Blank Children's Hospital Des Moines, Iowa  50309
The Toledo Hospital/Toledo Children's Hospital Toledo, Ohio  43606
Saint Christopher's Hospital for Children Philadelphia, Pennsylvania  19134
Greenville Cancer Treatment Center Greenville, South Carolina  29605
Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota  57117-5134
T C Thompson Children's Hospital Chattanooga, Tennessee  37403
Providence Sacred Heart Medical Center and Children's Hospital Spokane, Washington  99204
Broward Health Medical Center Fort Lauderdale, Florida  33316
Mattel Children's Hospital UCLA Los Angeles, California  90095