A Prospective Study Evaluating Complications and Clinical Response in Cancer Patients Treated With Anti-VEGF-Related Therapies
Overview
- Phase
- N/A
- Intervention
- Electronic Health Record Review
- Conditions
- Hematopoietic and Lymphoid Cell Neoplasm
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 170
- Locations
- 2
- Primary Endpoint
- Incidence of grade 3+ adverse events (AE) at least possibly related to anti-VEGF-related treatment (overall and each type separately)
- Status
- Recruiting
- Last Updated
- 2 months ago
Overview
Brief Summary
This study collects information about complications and clinical response in cancer patients treated with anti-VEGF-related therapies. This study aims to observe side effects that may happen to patients with advanced cancer who are treated with anti-VEGF related therapy. This may help doctors learn if there are any relationships between these side effects and how the disease may respond to treatment.
Detailed Description
PRIMARY OBJECTIVE: I. To explore the incidence of clinical complications associated with anti-VEGF-related therapies in cancer patients treated at Emory University and the University of Texas M.D. Anderson Cancer Center (MDACC). SECONDARY OBJECTIVES: I. To explore the correlation of clinical response rates to a novel blood pressure scoring system in cancer patients treated with anti-VEGF-related therapies. II. To explore the correlation of objective response to each toxicity grade 3 or higher in cancer patients treated with anti-VEGF-related therapies. III. To investigate the validity of a novel multi-parameter-based blood pressure scoring system and to determine if the new scoring method is concordant with the current Common Terminology Criteria for Adverse Events (CTCAE) method. OUTLINE: Patients' medical records are reviewed.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients must be able to understand and be willing to sign a written informed consent document
- •Patients must be receiving any anti-VEGF-related regimen in monotherapy or combination therapy
Exclusion Criteria
- Not provided
Arms & Interventions
Observational (medical records review)
Patients' medical records are reviewed.
Intervention: Electronic Health Record Review
Outcomes
Primary Outcomes
Incidence of grade 3+ adverse events (AE) at least possibly related to anti-VEGF-related treatment (overall and each type separately)
Time Frame: Up to 5 years
For each toxicity, will estimate the odds ratio, associated 95% confidence interval and p-value.