View Clinical Trial (Medical Research Study)
Umbrella Long-Term Follow-Up Protocol
| City: |
|
Ann Arbor |
| State: |
|
Michigan |
| Zip Code: |
|
48109 |
| Conditions: |
|
Brain and Central Nervous System Tumors - Chronic Myeloproliferative Disorders - Leukemia - Long-term Effects Secondary to Cancer Therapy in Children - Lymphoma - Lymphoproliferative Disorder - Multiple Myeloma and Plasma Cell Neoplasm - Myelodysplastic S |
| Purpose: |
|
RATIONALE: Developing a way to track patients enrolled in Children's Oncology Group studies
will help doctors gather long-term follow-up information and may help the study of cancer in
the future.
PURPOSE: This clinical trial is studying long-term follow-up in patients who are or have
participated in Children's Oncology Group studies.
|
| Study Summary: |
|
OBJECTIVES:
- To develop a mechanism for tracking and retaining patients enrolled on COG protocols.
- To maintain regular, lifetime contact with patients in order to obtain current
identification and contact information, and self/parent-reported health status.
- 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).
- 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.
- To facilitate collection of protocol-specific outcome data through collaboration with
the COG Late Effects Committee, the SDC, and the member institutions.
- 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.
|
| Criteria: |
|
DISEASE CHARACTERISTICS:
- Must be newly diagnosed with a primary malignancy and enrolled on a frontline 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
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
|
| NCT ID: |
|
NCT00736749 |
| Primary Contact: |
|
Study Chair
Smita Bhatia, MD, MPH
Beckman Research Institute
|
| Backup Contact: |
|
N/A |
| Location Contact: |
|
Ann Arbor, Michigan 48109
United States
Clinical Trials Office - C.S. Mott Children's Hospital
Phone: 800-865-1125
Site Status: Recruiting |
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
May 23, 2013 |
| Modifications to this listing: |
|
Only selected fields are shown, please use the link
below to view all information about this clinical trial. |
|
Click to view Full Listing
|