OsteosarcomaNCT02132182
Monocyte Phenotypic and Functional Differences
An observational study of Osteosarcoma, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Osteosarcoma
- What is being tested?
- Blood draw
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to 23 Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: A Canine/ Human Translational Model of Phenotypic and Functional Differences Between Monocytes in Patients With and Without Sarcoma
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.
Read the detailed description
Research on canine osteosarcoma lends itself well to comparative studies of osteosarcoma in humans because dogs develop spontaneous tumors which are similar to human cancers with the added benefit of frequently being more prevalent1. Osteosarcoma is diagnosed in more than 8000 dogs every year, and it affects mostly middle-aged to older dogs.2 The majority (75%) of canine osteosarcoma occurs in the appendicular skeleton.3 Osteosarcoma is diagnosed in 1-3 million humans every year, and is a disease primarily of those between 10 and 25 years old. Human osteosarcoma also occurs primarily in the appendicular skeleton, and like dogs, is most often found in the metaphyses of long bones. Pulmonary metastasis is the most common site of spread in dogs and humans, and is usually the cause of death in patients that have undergone standard of care therapy (surgical resection of tumor, chemotherapy).4 The reported median survival times for canine osteosarcoma have plateaued with no notable improvements in the last 20 years, despite attempts at various permutations of adjunctive chemotherapy.5,6,7 Targeting metastatic disease will be the key to improving survival in both canine and human osteosarcoma.
Interestingly, there is one arena in which median survival times in osteosarcoma have been extended - patients who develop infections after limb-spare surgery have been observed to double their median survival time. Lascelles et al. noted that infected dogs were half as likely to die, half as likely to develop metastasis, and these survival effects were due to a delay in metastasis rather than control of local tumor recurrence.8 A similar phenomenon of increased survival in infected human osteosarcoma patients has been observed. Jeys et al.reported that the 10-year survival rate in humans was significantly better in infected limb-spares: 84.5% in the infected patients versus 62.2% in the non-infected patients.9 An upregulation of antitumor immunity has been postulated to be potentially responsible for the favorable survivals in the face of an infection in dogs and humans. Characterization of the phenotype and function of circulating canine and human monocytes in normal subjects, and in osteosarcoma subjects with and without an infection will be crucial in furthering their understanding of how these cells are involved in the pathogenesis and potential suppression of osteosarcoma.
- Conditions
- Osteosarcoma
- Being tested
- Blood draw
- Medical subject headings
- Osteosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood drawBiological
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).
| Study group | Role | What they receive |
|---|---|---|
| Patients newly diagnosed with osteosarcoma | Blood draw Receives: Biological: Blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2014 (estimated)
- Study startOct 2014
- Primary completion23 Mar 2017
- Study completion23 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteosarcomaStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William Eward, MD, DVM, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02132182
- Sponsor's protocol ID
- Pro00050745
- Status last verified
- Jun 2018
- First submitted
- 21 Apr 2014
- Last updated
- 29 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Canine/ Human Translational Model of Phenotypic and Functional Differences Between Monocytes in Patients With and Without Sarcoma
- ClinicalTrials.gov ID
- NCT02132182
- Acronym / sponsor ID
- Pro00050745
- Conditions
- Osteosarcoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Oct 2014 (actual)
- Primary completion
- 23 Mar 2017 (actual)
- Study completion
- 23 Mar 2017 (actual)
- First posted
- 7 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Research on canine osteosarcoma lends itself well to comparative studies of osteosarcoma in humans because dogs develop spontaneous tumors which are similar to human cancers with the added benefit of frequently being more prevalent1. Osteosarcoma is diagnosed in more than 8000 dogs every year, and it affects mostly middle-aged to older dogs.2 The majority (75%) of canine osteosarcoma occurs in the appendicular skeleton.3 Osteosarcoma is diagnosed in 1-3 million humans every year, and is a disease primarily of those between 10 and 25 years old. Human osteosarcoma also occurs primarily in the appendicular skeleton, and like dogs, is most often found in the metaphyses of long bones. Pulmonary metastasis is the most common site of spread in dogs and humans, and is usually the cause of death in patients that have undergone standard of care therapy (surgical resection of tumor, chemotherapy).4 The reported median survival times for canine osteosarcoma have plateaued with no notable improvements in the last 20 years, despite attempts at various permutations of adjunctive chemotherapy.5,6,7 Targeting metastatic disease will be the key to improving survival in both canine and human osteosarcoma.
Interestingly, there is one arena in which median survival times in osteosarcoma have been extended - patients who develop infections after limb-spare surgery have been observed to double their median survival time. Lascelles et al. noted that infected dogs were half as likely to die, half as likely to develop metastasis, and these survival effects were due to a delay in metastasis rather than control of local tumor recurrence.8 A similar phenomenon of increased survival in infected human osteosarcoma patients has been observed. Jeys et al.reported that the 10-year survival rate in humans was significantly better in infected limb-spares: 84.5% in the infected patients versus 62.2% in the non-infected patients.9 An upregulation of antitumor immunity has been postulated to be potentially responsible for the favorable survivals in the face of an infection in dogs and humans. Characterization of the phenotype and function of circulating canine and human monocytes in normal subjects, and in osteosarcoma subjects with and without an infection will be crucial in furthering their understanding of how these cells are involved in the pathogenesis and potential suppression of osteosarcoma.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients newly diagnosed with osteosarcoma | – | Biological: Blood drawBlood draw |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood drawThe 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). | Biological | Patients newly diagnosed with osteosarcoma |
Primary outcome
Variations in the intensity of cell surface receptor expression
Time frame: 1 day
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2018.
Related trials for Osteosarcoma
RecruitingPhase 3
Fight Osteosarcoma Through European Research Evolving Study Platform From Diagnosis to Relapse
Osteosarcoma, Pediatric Osteosarcoma
RecruitingPhase 1
A Phase I Study of XS-02 Capsules in Patients With Advanced Solid Tumors
Solid Tumor, Ovarian Cancer
Active, not recruitingPhase 3
Combination Chemotherapy With or Without Ganitumab in Treating Patients With Newly Diagnosed Metastatic Ewing Sarcoma
Metastatic Ewing Sarcoma, Metastatic Malignant Neoplasm in the Bone
Recruiting
Medical Payment Case Management for Financial Toxicity in Patients With Primary Bone Tumors: A Randomized Controlled Trial
Bone Tumor, Bone Cancer
RecruitingPhase 1
AOH1996 for the Treatment of Refractory Solid Tumors
Refractory Malignant Solid Neoplasm, Osteosarcoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Eward, MD, DVM principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteosarcoma, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variations in the intensity of cell surface receptor expression (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2018.