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NCT03529565 · ClinicalTrials.gov registry record
Histamine and Bone Pain Association in Participants With Breast Cancer Metastatic in the Bone
A clinical trial, sponsored by Wake Forest University Health Sciences.
- Terminated
- Registry status
- 17
- Enrollment target
NCT03529565: Clinical Trial study, sponsored by Wake Forest University Health Sciences.
NCT03529565 is a clinical trial that was terminated before completion, run by Wake Forest University Health Sciences. The registered enrollment target is 17 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03529565 was terminated before completion, sponsored by Wake Forest University Health Sciences.
- TERMINATED
- Registry status
- 17 participants
- Enrollment target
Study Summary
This trial studies histamine and bone pain association in participants with breast cancer that has spread to the bone. Studying histamine levels in samples of blood from participants with breast cancer in the laboratory may help doctors learn more about reducing cancer bone pain and preventing further bone metastasis.
Primary Outcome
To correlate levels of histamine in plasma with pain scores (3 groups) in patients with bone metastases from breast cancer that have or have not been treated with palliative radiotherapy, analysis of variance (ANOVA) will be used. The histamine levels will be transformed to satisfy the conditional normality assumption if needed. Linear regression models will be used to relate histamine levels (outcome variable) with the pain groups (covariate of interest).
Interventions
- PROCEDURE Biospecimen Collection
- OTHER Quality-of-Life Assessment
- OTHER Laboratory Biomarker Analysis
- OTHER Questionnaire Administration
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2019-01-31 |
| Est. Completion | 2024-09-18 |
Why NCT03529565 stopped before completion
NCT03529565 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 17 participants, a relatively small participant target.
The record links to 0 conditions, and to 4 interventions - of which Biospecimen Collection is the first listed.
NCT03529565 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03529565 about?
NCT03529565 is a clinical study titled "Histamine and Bone Pain Association in Participants With Breast Cancer Metastatic in the Bone". This trial studies histamine and bone pain association in participants with breast cancer that has spread to the bone. Studying histamine levels in samples of blood from participants with breast cancer in the laboratory may help doctors learn more about reducing cancer bone pain and preventing furth...
What is the current status of trial NCT03529565?
This trial is currently terminated. The enrollment target is 17 participants. The study started on 2019-01-31. Estimated completion is 2024-09-18.
What interventions are being tested in trial NCT03529565?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Quality-of-Life Assessment (OTHER), Laboratory Biomarker Analysis (OTHER), Questionnaire Administration (OTHER).
Who is sponsoring clinical trial NCT03529565?
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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