Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05108519
Recruitment Status : Recruiting
First Posted : November 5, 2021
Last Update Posted : November 5, 2021
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment
Hematopoietic and Lymphoid Cell Neoplasm Malignant Solid Neoplasm Other: Electronic Health Record Review

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Case-Only
Time Perspective: Other
Official Title: A Prospective Study Evaluating Complications and Clinical Response in Cancer Patients Treated With Anti-VEGF-Related Therapies
Actual Study Start Date : April 8, 2019
Estimated Primary Completion Date : May 2, 2023
Estimated Study Completion Date : May 2, 2023

Group/Cohort Intervention/treatment
Observational (medical records review)
Patients' medical records are reviewed.
Other: Electronic Health Record Review
Medical records are reviewed




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients receiving any anti-VEGF-related regimen
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05108519


Locations
Layout table for location information
United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Nicolas L. Palaskas    713-563-3532    nlpalaskas@mdanderson.org   
Principal Investigator: Nicolas L. Palaskas         
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Layout table for investigator information
Principal Investigator: Nicolas L Palaskas M.D. Anderson Cancer Center
Additional Information:
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT05108519    
Other Study ID Numbers: PA18-1070
NCI-2021-06311 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: November 5, 2021    Key Record Dates
Last Update Posted: November 5, 2021
Last Verified: October 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms