A Non-interventional Observational Study of Infectious Complications in Cancer Patients
This study is currently recruiting participants.
Verified January 2013 by University of Arkansas
Sponsor:
University of Arkansas
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT01622595
First received: June 15, 2012
Last updated: January 7, 2013
Last verified: January 2013
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Purpose
OBSERVATIONAL STUDY OF INFECTIOUS COMPLICATIONS IN CANCER PATIENTS
| Condition |
|---|
|
Aspergillosis Candidemia C. Difficile |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Retrospective |
| Official Title: | A Non-interventional Observational Study of Infectious Complications in Cancer Patients |
Resource links provided by NLM:
Further study details as provided by University of Arkansas:
Primary Outcome Measures:
- To study the incidence, risk factors, clinical presentation, diagnosis and prognostic factors of infectious complications in cancer patients [ Time Frame: 3 years ] [ Designated as safety issue: No ]To study the incidence, risk factors, clinical presentation, diagnosis and prognostic factors of infectious complications in cancer patients
Secondary Outcome Measures:
- incidence [ Time Frame: 3 years ] [ Designated as safety issue: No ]
To determine the overall incidence of different infections, including bacterial, fungal and viral infections in cancer patients receiving chemotherapy and / or hematopoietic stem cell transplantation.
- To describe the natural history of such infections in cancer patients.
- To monitor the adherence of Myeloma institute for research and therapy(MIRT) health care workers to the MIRT standard operational procedures (SOPs)
- To identify risk factors for the development of specific infections.
- To validate surrogate markers as early diagnostic tools for various infections.
| Estimated Enrollment: | 600 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
A NON-INTERVENTIONAL, OBSERVATIONAL STUDY OF INFECTIOUS COMPLICATIONS IN CANCER PATIENTS
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
cancer patients with Infections
Criteria
Inclusion Criteria:
- cancer patients with Infections
Exclusion Criteria:
- No Infections
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01622595
Locations
| United States, Arkansas | |
| University of Arkansas for Medical Sciences | Recruiting |
| Little Rock, Arkansas, United States, 72205 | |
| Contact: Naveen s, MD, MHSA 501-681-1972 nsanathkumar@uams.edu | |
| Principal Investigator: Senu Apewokin, MD | |
| Sub-Investigator: Naveen Sanath Kumar, MD, MHSA | |
Sponsors and Collaborators
University of Arkansas
Investigators
| Principal Investigator: | Senu Apewokin, MD | UAMS |
More Information
No publications provided
| Responsible Party: | University of Arkansas |
| ClinicalTrials.gov Identifier: | NCT01622595 History of Changes |
| Other Study ID Numbers: | UARK 2009-99 |
| Study First Received: | June 15, 2012 |
| Last Updated: | January 7, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Arkansas:
|
Aspergillosis Candidemia Candidiasis C. Difficile |
cytomegalovirus respiratory syncytial virus (RSV) Influenza CONS |
Additional relevant MeSH terms:
|
Aspergillosis Candidemia Mycoses Fungemia Sepsis Infection |
Candidiasis, Invasive Candidiasis Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes |
ClinicalTrials.gov processed this record on June 13, 2013