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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 UniversityBaltimore, Maryland  21205
Cleveland Clinic FoundationCleveland, Ohio  44195
Roswell Park Cancer InstituteBuffalo, New York  14263
Mayo ClinicRochester, Minnesota  55905
Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania  19104
University of Iowa Hospitals and ClinicsIowa City, Iowa  52242
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Washington University School of MedicineSaint Louis, Missouri  63110
Medical University of South CarolinaCharleston, South Carolina  29425-0721
Rhode Island HospitalProvidence, Rhode Island  02903
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
Midwest Children's Cancer CenterMilwaukee, Wisconsin  53226
Sinai Hospital of BaltimoreBaltimore, Maryland  21225
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
Morristown Memorial HospitalMorristown, New Jersey  07962-1956
Marshfield ClinicMarshfield, Wisconsin  54449
Loma Linda University Medical CenterLoma Linda, California  92354
Baptist Hospital of MiamiMiami, Florida  33176-2197
Newark Beth Israel Medical CenterNewark, New Jersey  07112
New York Medical CollegeValhalla, New York  10595
Cedars-Sinai Medical CenterLos Angeles, California  90048
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Hackensack University Medical CenterHackensack, New Jersey  07601
Children's Hospital Los AngelesLos Angeles, California  90027-0700
Children's National Medical CenterWashington, District of Columbia  20010-2970
All Children's HospitalSt. Petersburg, Florida  33701
Advocate Hope Children's HospitalOak Lawn, Illinois  60453
Saint Jude Midwest AffiliatePeoria, Illinois  61637
Carolinas Medical CenterCharlotte, North Carolina  28232-2861
University of Oklahoma Health Sciences CenterOklahoma City, Oklahoma  73104
St. Jude Children's Research HospitalMemphis, Tennessee  38105-2794
Driscoll Children's HospitalCorpus Christi, Texas  78466
Inova Fairfax HospitalFalls Church, Virginia  22042-3300
Southern California Permanente Medical GroupDowney, California  90242
Children's Hospital Central CaliforniaMadera, California  93638-8762
Kosair Children's HospitalLouisville, Kentucky  40202-3830
Children's Hospital Medical Center of AkronAkron, Ohio  44308
Overlook HospitalSummit, New Jersey  07902-0220
Winthrop University HospitalMineola, New York  11501
Mount Sinai Medical CenterNew York, New York  10029
Cincinnati Children's Hospital Medical CenterCincinnati, Ohio  45229-3039
Primary Children's Medical CenterSalt Lake City, Utah  84113-1100
Montefiore Medical CenterBronx, New York  10467-2490
Saint Peter's University HospitalNew Brunswick, New Jersey  08901-1780
Rady Children's Hospital - San DiegoSan Diego, California  92123-4282
Children's Hospitals and Clinics of Minnesota - MinneapolisMinneapolis, Minnesota  55404
University of New Mexico Cancer CenterAlbuquerque, New Mexico  87131-5636
Nationwide Children's HospitalColumbus, Ohio  43205-2696
Children's Hospital of Pittsburgh of UPMCPittsburgh, Pennsylvania  15213
Dell Children's Medical Center of Central TexasAustin, Texas  78723
Mary Bridge Children's Hospital and Health CenterTacoma, Washington  98415-0299
City of Hope Medical CenterDuarte, California  91010
Presbyterian HospitalCharlotte, North Carolina  28233-3549
Lee Memorial Health SystemFort Myers, Florida  33902
University of Alabama at BirminghamBirmingham, Alabama  35294-3300
Children's Hospital of AlabamaBirmingham, Alabama  35233
Connecticut Children's Medical CenterHartford, Connecticut  06106
University of North CarolinaChapel Hill, North Carolina  27599
Duke University Medical CenterDurham, North Carolina  27710
University of RochesterRochester, New York  14642
Nemours Children's Clinic - PensacolaPensacola, Florida  32504
Helen DeVos Children's Hospital at Spectrum HealthGrand Rapids, Michigan  49503
Yale UniversityNew Haven, Connecticut  06520
Wayne State UniversityDetroit, Michigan  48202
Mercy Children's HospitalToledo, Ohio  43608
BI-LO Charities Children's Cancer CenterGreenville, South Carolina  29605
Dartmouth Hitchcock Medical CenterLebanon, New Hampshire  03756
University Of VermontBurlington,, Vermont  05403
Albany Medical CenterAlbany, New York  12208
University of Texas Southwestern Medical CenterDallas, Texas  
University of KentuckyLexington, Kentucky  40536-0098
UC Davis Comprehensive Cancer CenterSacramento, California  95817
Tulane University Health Sciences CenterNew Orleans, Louisiana  70112
Virginia Commonwealth UniversityRichmond, Virginia  
David Geffen School of Medicine at UCLALos Angeles, California  90095
Florida HospitalOrlando, Florida  32803
University of Chicago Comprehensive Cancer CenterChicago, Illinois  60637-1470
Seattle Children's HospitalSeattle, Washington  98105
Wake Forest University Health SciencesWinston-Salem, North Carolina  27157
Childrens Memorial HospitalChicago, Illinois  60614
Kaiser Permanente-OaklandOakland, California  94611
Lombardi Comprehensive Cancer Center at Georgetown UniversityWashington, District of Columbia  20057
M D Anderson Cancer Center- OrlandoOrlando, Florida  32806
University of HawaiiHonolulu, Hawaii  96813
Saint Luke's Mountain States Tumor InstituteBoise, Idaho  83712
Saint Vincent Hospital and Health ServicesIndianapolis, Indiana  46260
Saint John Hospital and Medical CenterDetroit, Michigan  48236
Nevada Cancer Research Foundation CCOPLas Vegas, Nevada  89106
Columbia University Medical CenterNew York, New York  10032
State University of New York Upstate Medical UniversitySyracuse, New York  13210
Mission Hospitals IncAsheville, North Carolina  28801
Natalie W Bryant Cancer CenterTulsa, Oklahoma  74136
Saint Vincent HospitalGreen Bay, Wisconsin  54301
University of South AlabamaMobile, Alabama  36693
University of IllinoisChicago, Illinois  60612
Cook Children's Medical CenterFort Worth, Texas  76104
East Carolina UniversityGreenville, North Carolina  27858
West Virginia University CharlestonCharleston, West Virginia  25304
The Children's Medical Center of DaytonDayton, Ohio  45404
University of Minnesota Medical Center-FairviewMinneapolis, Minnesota  55455
Children's Oncology GroupArcadia, California  91006-3776
C S Mott Children's HospitalAnn Arbor, Michigan  48109
Southern Illinois UniversitySpringfield, Illinois  62702
University Of Missouri-ColumbiaColumbia, Missouri  65212
Walter Reed National Military Medical CenterBethesda, Maryland  20889
Riley Hospital for ChildrenIndianapolis, Indiana  46202
UMDNJ - Robert Wood Johnson University HospitalNew Brunswick, New Jersey  08903
Phoenix Childrens HospitalPhoenix, Arizona  85016
Miller Children's HospitalLong Beach, California  90806
Childrens Hospital of Orange CountyOrange, California  92868-3874
Alfred I duPont Hospital for ChildrenWilmington, Delaware  19803
Nemours Children's Clinic - JacksonvilleJacksonville, Florida  32207-8426
Nemours Childrens Clinic - OrlandoOrlando, Florida  32806
Saint Joseph Children's Hospital of TampaTampa, Florida  33607
Children's Healthcare of Atlanta - EglestonAtlanta, Georgia  30322
The Childrens Mercy HospitalKansas City, Missouri  64108
Rainbow Babies and Childrens HospitalCleveland, Ohio  44106
Penn State Hershey Children's HospitalHershey, Pennsylvania  17033
Palmetto Health RichlandColumbia, South Carolina  29203
East Tennessee Childrens HospitalKnoxville, Tennessee  37916
Saint Joseph's Regional Medical CenterPaterson, New Jersey  07503
Sanford Medical Center-FargoFargo, North Dakota  58122
Children's Hospital ColoradoAurora, Colorado  80045
Floating Hospital for Children at Tufts Medical CenterBoston, Massachusetts  02111
Lucile Packard Children's Hospital Stanford UniversityPalo Alto, California  94304
University of California San Francisco Medical Center-ParnassusSan Francisco, California  94143
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical CenterDenver, Colorado  80218
Raymond Blank Children's HospitalDes Moines, Iowa  50309
The Toledo Hospital/Toledo Children's HospitalToledo, Ohio  43606
Saint Christopher's Hospital for ChildrenPhiladelphia, Pennsylvania  19134
Greenville Cancer Treatment CenterGreenville, South Carolina  29605
Sanford USD Medical Center - Sioux FallsSioux Falls, South Dakota  57117-5134
T C Thompson Children's HospitalChattanooga, Tennessee  37403
Providence Sacred Heart Medical Center and Children's HospitalSpokane, Washington  99204
Broward Health Medical CenterFort Lauderdale, Florida  33316
Mattel Children's Hospital UCLALos Angeles, California  90095