Long-Term Follow-Up of Patients Who Have Participated in Children's Oncology Group Studies
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorChildren's Oncology Group
About this trial
This clinical trial keeps track of and collects follow-up information from patients who are currently enrolled on or have participated in a Children's Oncology Group study. Developing a way to keep track of patients who have participated in Children's Oncology Group studies may allow doctors learn more about the long-term effects of cancer treatment and help them reduce problems related to treatment and improve patient quality of life.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The patient must reside in the U.S. on the date of enrollment to ALTE05N1
All patients and/or their parents or legal guardians must sign a written informed consent
All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Disqualifiers
None
Trial design
Treatments tested in this trial
Assessment of Therapy Complications
Procedure/SurgeryComplete patient response form and Health Status Update Form
Questionnaire Administration
Other interventionComplete patient response form, Health Status Update Form (called the "Keep in Touch" form), and Quality of Life Questionnaire (PROMIS)
Treatment groups
25,000 Participants
are divided into 1 treatment groupGroup A: Observational (long-term follow-up)2 interventions
Trial outcomes
Primary outcomes
1
Percentage of patients enrolled
Time frame
Up to 20 years2
Percentage of patients in which long-term (20+ years) contact is maintained
Time frame
Up to 20 years3
Percentage of eligible patients located who were lost to follow-up
Time frame
Up to 20 years4
Percentage of located patients enrolled
Differences between participants and non-participants will be examined annually, in terms of demographic (age, sex, ethnicity) and clinical characteristics (primary diagnosis, therapeutic protocol, time since diagnosis, treating institution).
Time frame
Up to 20 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Children's Oncology Group
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov