Monocyte Phenotypic and Functional Differences

NCT02132182 | Completed DMC

• 1 other identifier: Pro00050745
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to identify phenotypic (cell surface receptor expression) and functional differences in monocyte populations in humans with osteosarcoma as compared to published historical data on normal human monocyte values. The biologic similarity between canine and human osteosarcoma makes it a disease model that holds promise for translational research possibilities. The phenotypic and functional differences the investigators expect to find in canine and human monocytes between normal and osteosarcoma subjects in this pilot work will allow us to launch a program of investigations to further their understanding as to what characteristics are associated with improved survival in canine and human osteosarcoma. Such data will represent the foundation upon which the investigators can plan future investigations designed to exploit the potential anti-tumor capabilities of monocytes and macrophages in canine and human osteosarcoma.

Conditions

Osteosarcoma

Outcome Measures

Primary Outcomes (1)

• Variations in the intensity of cell surface receptor expression

  We will characterize the phenotypic differences demonstrated by variations in cell surface receptor expression, such as CCR2, CCR7 and CD32, between normal monocytes and monocytes in osteosarcoma patients.

  1 day

Study Arms (1)

Patients newly diagnosed with osteosarcoma

Blood draw

Biological: Blood draw

Interventions

Blood draw BIOLOGICAL

The patient population for this study will be comprised of individuals who present to clinic with newly diagnosed osteosarcoma with or without infection and without known metastasis to the lung. These patients would have a standard-of-care blood draw. For the study we will be drawing an additional 15-20mL of blood (no additional needle stick).

Patients newly diagnosed with osteosarcoma

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patient population for this study will be comprised of individuals who present to clinic with newly diagnosed osteosarcoma with or without infection and without known metastasis to the lung. Potential subjects will be 10 years or older.

You may qualify if:

• Patients presenting for evaluation of osteosarcoma of the appendicular skeleton
• Patient is 6years or older at time of visit
• Patients do not need to be eligible for surgery
• Patients may have known infection related to osteosarcoma and its treatment (ex. surgical wound infection)
• Patients who would normally have a blood draw as part of their standard care

You may not qualify if:

• Patients younger than 10 years of age
• Patients who are unwilling/unable to undergo blood draw
• Patients with known infection unrelated to osteosarcoma or its treatment
• Patients with known systemic immune-mediated disease including but not limited to lymphoma, AIDS/HIV, Lupus, etc.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood samples (\~15 to 20 mls) will be obtained from 90 humans over 3 years presenting to Duke with osteosarcoma. Only patients who would normally have blood drawn as part of standard care will be included. Research blood will be in addition to what is normally collected. Samples will be de-identified and then transferred to researchers as NC State's College of Veterinary Medicine. These researchers will use the samples to perform a CBC and evaluate monocyte phenotype and function. These results will be compared to published historical normal values for healthy human monocytes. This data will also be compared with canine data already gathered.

MeSH Terms

Conditions

Osteosarcoma

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• William Eward, MD, DVM

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2014
• First Posted: May 7, 2014
• Study Start: October 1, 2014
• Primary Completion: March 23, 2017
• Study Completion: March 23, 2017
• Last Updated: June 29, 2018

Record last verified: 2018-06

Locations

US (1)