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NCT00923650 · ClinicalTrials.gov registry record
Informed Consent in Pediatric Cancer Trials
A clinical trial, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- 1
- Enrollment target
NCT00923650: Completed study, sponsored by National Cancer Institute (NCI).
NCT00923650 is a clinical trial that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 1 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00923650 has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- 1 participants
- Enrollment target
Study 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 consists of meetings and discussions with the health care team. * Phase I clinical trials are designed to determine what dose of an investigational agent is safe to administer to patients. Objectives: * To study communication, comprehension and decision-making during the informed consent process. * To examine ethical, psychological, social, and educational issues regarding informed consent. * To help researchers understand how to improve informed consent and education about clinical research. Eligibility: * Parents or guardians of children with cancer who are being considered for participation in phase I clinical trials * Prospective patients for pediatric phase I clinical trials who are between 14 and 21 years of age. * Members of the research team who obtain consent from patients and families for pediatric phase I clinical trials Design: * Research assistants observe and record the informed consent conference held with the research team and the parents and children. * After the conference, the research assistant interviews the parents in a private area about their experience during the conference and their decision-making process. They are asked about their thoughts and opinions during the informed consent conference, including the decision-making process, communication and trust in the medical team. * With their parent's permission, patients are interviewed privately to discuss their experience during the informed consent conference. * After parents and patients have made their decision about participation in the study, they are interviewed again about how they made the decision, aspects of the communication during the conference, and how they feel about the doctor. This interview is also recorded. * Parents may be contacted 6 months to 2 years from the time of their
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2008-12-09 |
| Est. Completion | 2010-02-02 |
What the finished NCT00923650 record still lists
NCT00923650 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 1 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT00923650 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00923650 about?
NCT00923650 is a clinical study titled "Informed Consent in Pediatric Cancer Trials". 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 consists of meetings and discussions with the health care team. * Phase I clinical trials are designed to ...
What is the current status of trial NCT00923650?
This trial is currently completed. The enrollment target is 1 participants. The study started on 2008-12-09. Estimated completion is 2010-02-02.
Who is sponsoring clinical trial NCT00923650?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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