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Patient-Reported Outcome Version of the Common Criteria for Adverse Events
NCT04050072 · View on ClinicalTrials.gov ↗
Study Summary
Childhood cancer survivors are vulnerable to treatment-related late effects, including physical and psychosocial morbidities, subsequent malignancies, and premature death. Symptom assessment provides a unique insight into survivorship care since symptoms not only indicate the manifestation for the occurrence of chronic health conditions, but also impact quality of life and survival. The National Cancer Institute (NCI) has developed a Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) to assess symptomatic adverse events (AEs) for adult-onset cancer patients who are receiving cancer therapies. However, content-appropriate and clinically validated symptom assessment tools for adult survivors of childhood cancer are not available. Primary Object 1: Establish content validity for the PRO-CTCAE-SCC Primary Objective 1A: Conduct a symptom selection process through qualitative research to identify symptomatic AEs for adult survivors of childhood cancer Primary Objective 1B: Create symptomatic AE items for adult survivors of childhood cancer based on the prevalence and clinical importance ratings on the items Primary Objective 2: Validate the PRO-CTCAE-SCC using psychometric methods and objective clinical parameters Primary Objective 2A: Test dimensionality for the PRO-CTCAE-SCC Primary Objective 2B: Test clinical validity for the PRO-CTCAE-SCC Primary Objective 2C: Test responsiveness to change for the PRO-CTCAE-SCC Secondary Objective 1: Increase clinical usefulness of the PRO-CTCAE-SCC Secondary Objective 2: Establish meaningful cut-points and minimally important differences (MIDs) on symptom burden scores for clinical decision-making
Conditions Studied
Interventions
- OTHER Childhood Cancer Survivors (CCSS)
- OTHER SJLIFE
- OTHER Community non-cancer control
Study Locations (1)
Tennessee
- St. Jude Children's Research Hospital — Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 837 participants |
| Start Date | 2019-12-16 |
| Est. Completion | 2027-07 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04050072
The ClinicalTrials.gov registry entry for NCT04050072 describes a study currently listed as active not recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 837 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is St. Jude Children's Research Hospital, which has 441 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Cancer appearing as the primary indexed condition, and to 3 interventions — of which Childhood Cancer Survivors (CCSS) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04050072 reports 1 study location spanning 1 distinct geographic area — top geographies include Tennessee. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04050072 about?
NCT04050072 is a clinical study titled "Patient-Reported Outcome Version of the Common Criteria for Adverse Events". Childhood cancer survivors are vulnerable to treatment-related late effects, including physical and psychosocial morbidities, subsequent malignancies, and premature death. Symptom assessment provides a unique insight into survivorship care since symptoms not only indicate the manifestation for the o...
What is the current status of trial NCT04050072?
This trial is currently active not recruiting. The enrollment target is 837 participants. The study started on 2019-12-16. Estimated completion is 2027-07.
What conditions does trial NCT04050072 study?
This clinical trial studies the following conditions: Cancer, Survivorship. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04050072?
The interventions under investigation include: Childhood Cancer Survivors (CCSS) (OTHER), SJLIFE (OTHER), Community non-cancer control (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04050072?
This trial is sponsored by St. Jude Children's Research Hospital, which has 441 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04050072 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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