Histamine and Bone Pain Association in Participants With Breast Cancer Metastatic in the Bone
NCT ID: NCT03529565
Last Updated: 2024-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
17 participants
OBSERVATIONAL
2019-01-31
2024-09-18
Brief Summary
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Detailed Description
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I. To correlate levels of histamine in plasma with pain scores in patients with bone metastases from breast cancer that have or have not been treated with palliative radiotherapy.
SECONDARY OBJECTIVES:
I. To perform exploratory studies with additional markers not mentioned, including calcitonin gene-related peptide (CGRP), stem cell factor (SCF), angiotensin II (Ang II) substance P, angiotensin 1-7 (Ang1-7), may be performed at the investigator's discretion.
II. To perform next generation ribonucleic acid (RNA) sequences using the whole blood to determine whether histamine system is involved in the development of cancer-induced bone pain (CIBP).
III. To assess the impact of pain response after radiotherapy on bone structural properties such as bone mineral density and cortical thickness, and patient quality of life, physical and psychological function.
OUTLINE:
Participants undergo collection of blood samples for histamine level analysis via enzyme-linked immunosorbent assay (ELISA).
After completion of study, participants are followed up at 1, 3, and 6 months.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Ancillary-Correlative (biospecimen collection)
Participants undergo collection of blood samples for histamine level analysis via ELISA.
Biospecimen Collection
Undergo collection of blood
Laboratory Biomarker Analysis
Correlative studies
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Interventions
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Biospecimen Collection
Undergo collection of blood
Laboratory Biomarker Analysis
Correlative studies
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Weight bearing sites: pelvis (excluding pubis), femur, sacrum and/or sacroiliac joints, tibia, up to 5 consecutive cervical, thoracic or lumbar vertebral bodies, lumbosacral spine
* Non-weight bearing sites: up to 3 consecutive ribs, humerus, fibula, radius +/- ulna, clavicle, sternum, scapula, pubis
* Patients with and without pain related to the radiographically documented metastases are eligible for study
* Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document
Exclusion Criteria
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Doris Brown
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Locations
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Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Countries
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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NCI-2018-00277
Identifier Type: REGISTRY
Identifier Source: secondary_id
CCCWFU 02217
Identifier Type: OTHER
Identifier Source: secondary_id
IRB00048455
Identifier Type: -
Identifier Source: org_study_id
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