CARG, VES13, G8 Scales in Predicting Drug Toxicity in Patients Receiving Nivolumab

October 2, 2022 updated by: Asoc. Prof. Erdoğan Selçuk Şeber, Namik Kemal University
The Geriatric 8 (G8), Vulnerable Elders Survey (VES-13), and Cancer and Aging Research Group (CARG) questionnaires are among the main tests whose purpose is to predict the risk of chemotherapy-induced toxicity (CRT) and allow treatment. Investigators aimed to investigate the effect of using the G8, VES13, and CARG scales in the geriatric age group in cancer patients receiving nivolumab treatment in predicting side effects.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Investigator aimed to examine whether the G8, VES13, and CARG scales can shed light on clinicians in predicting side effects during the use of nivolumab in geriatric cancer patients. In the chemotherapy unit, demographic information, diagnosis date of the disease, previous treatments, comorbidities, and CARG, VES13, and G8 questionnaires will be recorded face-to-face to the patients who meet the study criteria. In addition, routine hemogram and biochemistry tests, which were requested by the patient's follow-up physician before Nivolumab treatment and which will be requested by the patient's own physician during follow-up visits, will be recorded prospectively. Side effects that may occur during nivolumab treatment will be pursued at each visit. CTCA v.6. will be used for grading.

inclusion criteria

1-Advanced cancer patients whose nivolumab treatment was started by the physician followed up (independent of diagnosis) 2-60 years and over, 3-ECOG performance score 0-1 4-Patients who signed the informed consent form

exclusion criteria

  1. Under 60 years old
  2. Ecog score >1

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Tekirdağ, Turkey
        • Recruiting
        • Tekirdag Namık Kemal University
        • Contact:
        • Contact:
          • Phone Number: 5542916110
        • Principal Investigator:
          • Kubilay Karaboyun, MD
        • Sub-Investigator:
          • Yakup İriağaç, MD
        • Sub-Investigator:
          • Okan Avcı, MD
        • Sub-Investigator:
          • Eyyüp Çavdar, MD
        • Sub-Investigator:
          • Erdoğan S Şeber, Assoc. Prof

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Advanced stage cancer patients who have been treated with nivolumab

Description

Inclusion Criteria:

  • Advanced stage cancer patients who have been treated with nivolumab
  • be over 60 years old

Exclusion Criteria:

  • be under the age of 60

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
group 1
Advanced cancer patients over 65 years of age receiving nivolumab
Drug: there is no intervention
there is no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
grade 3-4 nivolumab toxicity
Time Frame: one year from first patient enrolled
grading will be made according to the CTCA V.6
one year from first patient enrolled

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Namik Kemal University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 2, 2022

Primary Completion (Anticipated)

June 17, 2023

Study Completion (Anticipated)

August 17, 2023

Study Registration Dates

First Submitted

September 2, 2022

First Submitted That Met QC Criteria

October 2, 2022

First Posted (Actual)

October 4, 2022

Study Record Updates

Last Update Posted (Actual)

October 4, 2022

Last Update Submitted That Met QC Criteria

October 2, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIVOTOXTOOL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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