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NCT04727827 · ClinicalTrials.gov registry record · NA
Pharmacogenomic-Guided Supportive Care in Hematopoietic Cell Transplantation
A NA study, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- NA
- Development phase
- 110
- Enrollment target
NCT04727827 is a NA study that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 110 participants.
The verdict
NCT04727827, a NA study, has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- NA
- Development phase
- 110 participants
- Enrollment target
Study Summary
Hematopoietic cell transplantation (HCT) is the only curative treatment modality for many hematologic malignancies. Morbidity and mortality rates have declined drastically over the years, secondary to improvements in both transplant techniques and pharmacotherapies, including immunosuppressants, anti-infectives, analgesics and other supportive care medications. Despite advances in patient care, toxicities associated with HCT (e.g., graft-versus-host disease (GVHD), infection, pain, anxiety, depression, mucositis, nausea/vomiting) continue to pose challenges in patient care and have a significant impact on quality of life. (QOL). A recent study demonstrated subjects randomized to intensive supportive care had a clinically significant improvement in their QOL during hospitalization and up to 3 months post-transplant compared to those receiving standard care. Further follow up evaluations have evaluated the impact of focused palliative care/symptom management on QOL metrics - inclusive of Edmonton Symptom Assessment surveys (ESAS). In other malignant settings, i.e. solid tumor, ESAS has been noted as an effective measure of symptoms control and the utilization of this assessment is linked to positive outcomes. The American Society of Clinical Oncology (ASCO) has designated QOL as the second most relevant metric for post-transplant patient care behind survival, making the optimization of supportive care pharmacotherapy a clinically relevant subject to investigate. Pharmacogenetics (PGx) uses an individual's genetic factors, such as single nucleotide polymorphisms (SNPs), to personalize therapy or dose selection. SNPs encode drug-metabolizing enzymes, transporters, and targets that can significantly impact drug efficacy and toxicity. With the growing complexity of both antineoplastics and supportive care, oncologists have less time to manage each subject's myriad of supportive care concerns by trial and error. Suboptimal management of symptoms compromises potential bene
Interventions
- OTHER Pharmacogenomic-guided supportive care
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2021-02-01 |
| Est. Completion | 2023-06-09 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04727827
The ClinicalTrials.gov registry entry for NCT04727827 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 110 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wake Forest University Health Sciences, which has 1,140 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Pharmacogenomic-guided supportive care is the first listed.
NCT04727827 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04727827 about?
NCT04727827 is a clinical study titled "Pharmacogenomic-Guided Supportive Care in Hematopoietic Cell Transplantation". Hematopoietic cell transplantation (HCT) is the only curative treatment modality for many hematologic malignancies. Morbidity and mortality rates have declined drastically over the years, secondary to improvements in both transplant techniques and pharmacotherapies, including immunosuppressants, ant...
What is the current status of trial NCT04727827?
This trial is currently completed. It is a NA study. The enrollment target is 110 participants. The study started on 2021-02-01. Estimated completion is 2023-06-09.
What interventions are being tested in trial NCT04727827?
The interventions under investigation include: Pharmacogenomic-guided supportive care (OTHER).
Who is sponsoring clinical trial NCT04727827?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
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