NCT05564923

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 2, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

September 2, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 4, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 17, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 17, 2023

Completed
Last Updated

October 4, 2022

Status Verified

October 1, 2022

Enrollment Period

10 months

First QC Date

September 2, 2022

Last Update Submit

October 2, 2022

Conditions

Nivolumab Related Toxicity

Outcome Measures

Primary Outcomes (1)

  • grade 3-4 nivolumab toxicity

    grading will be made according to the CTCA V.6

    one year from first patient enrolled

Study Arms (1)

group 1

Advanced cancer patients over 65 years of age receiving nivolumab

Drug: there is no intervention

Interventions

there is no interventionDRUG

there is no intervention

group 1

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Advanced stage cancer patients who have been treated with nivolumab

You may qualify if:

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

You may not qualify if:

  • be under the age of 60

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tekirdağ Namık Kemal University

Tekirdağ, Turkey (Türkiye)

RECRUITING

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asoc Prof.

Study Record Dates

First Submitted

September 2, 2022

First Posted

October 4, 2022

Study Start

September 2, 2022

Primary Completion

June 17, 2023

Study Completion

August 17, 2023

Last Updated

October 4, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)