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Recruiting NCT05108519

Complications and Clinical Response in Cancer Patients Treated With Anti-VEGF-Related Therapies

Observational Hematopoietic and Lymphoid Cell Neoplasm Malignant Solid Neoplasm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Electronic Health Record Review.
Who it may be relevant to
Registry conditions: Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

A Prospective Study Evaluating Complications and Clinical Response in Cancer Patients Treated With Anti-VEGF-Related Therapies

Overview

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.

Interventions

  • Other Electronic Health Record Review
    Medical records are reviewed

Primary outcome measures

  • 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

United States · 1 center
  • M D Anderson Cancer Center — Houston

Identifiers

NCT: NCT05108519 · PA18-1070 · NCI-2021-06311

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗