Status:
COMPLETED
Informed Consent in Pediatric Cancer Trials
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Osteosarcoma
Ewing's Sarcoma
Eligibility:
All Genders
Up to 21 years
Brief Summary
Background: * Informed consent is the process by which prospective participants in clinical trials learn about clinical research in order to decide whether they want to enroll in the study. It consis...
Detailed Description
Background: * The clinical course and poor prognosis of children and adolescents eligible for pediatric phase I trials may increase the vulnerability of patients and their families and confound infor...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Parent/Guardian:
- Patient must be less than or equal to 21 years of age at the time of consent.
- Parent/guardian must be considering having their child participate in a Phase I treatment trial
- Parents must be able to speak English or Spanish
- Must sign informed consent for participation in this study
- Patients greater than or equal to14 years of age and less than or equal to 18 years of age:
- Must be considering participating in a Phase I treatment trial
- Must be able to speak English or Spanish
- Must assent for participation in this study
- Patients greater than or equal to 18 years old:
- Must be considering participating in a Phase I treatment trial
- Must be able to speak English or Spanish
- Must sign informed consent for participation in this study, which will include consent to interview parent/guardian, if available
- Heath Care Team Members:
- Must be greater than or equal to 18 years of age
- Must speak English or Spanish
- Must sign an informed consent document for participation in this study (written consent will be obtained annually for heath care team members)
- Verbal assent to participate in each individual consent conference
- EXCLUSION CRITERIA:
- Patients who are newly diagnosed who are being offered participation in a Phase I trial because no standard therapy exists for their disease
- Patients/Parents who have previously participated in informed consent research conducted by Cleveland Clinic Foundation Department of Bioethics
- Families who do not speak English or Spanish
Exclusion
Key Trial Info
Start Date :
December 9 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 2 2010
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00923650
Start Date
December 9 2008
End Date
February 2 2010
Last Update
July 2 2017
Active Locations (2)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
2
Cleveland Clinic Foundation Childrens Hospital
Cleveland, Ohio, United States, 44195