Nivolumab Related ToxicityNCT05564923
CARG, VES13, G8 Scales in Predicting Drug Toxicity in Patients Receiving Nivolumab
An observational study of Nivolumab Related Toxicity, run by Namik Kemal University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Nivolumab Related Toxicity
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Sep 2022to 17 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Advanced stage cancer patients who have been treated with nivolumab
Who may be able to join
- Advanced stage cancer patients who have been treated with nivolumab
- be over 60 years old
Who cannot join
- be under the age of 60
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Tekirdağ Namık Kemal University
Tekirdağ
Kubilay Karaboyun, MD, 5542916110, kubilaykaraboyun@gmail.com
5542916110
About this study
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.
Read the 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
- Under 60 years old
- Ecog score >1
- Conditions
- Nivolumab Related Toxicity
- Being tested
- there is no intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
there is no interventionDrug
there is no intervention
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Advanced cancer patients over 65 years of age receiving nivolumab Receives: Drug: there is no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
grade 3-4 nivolumab toxicity
grading will be made according to the CTCA V.6
Measured: one year from first patient enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start2 Sep 2022
- Primary completion17 Jun 2023 (estimated)
- Study completion17 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nivolumab Related ToxicityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Namik Kemal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asoc. Prof. Erdoğan Selçuk Şeber, Namik Kemal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05564923
- Sponsor's protocol ID
- NIVOTOXTOOL
- Status last verified
- Oct 2022
- First submitted
- 2 Sep 2022
- Last updated
- 4 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CARG, VES13, G8 Scales in Predicting Drug Toxicity in Patients Receiving Nivolumab
- ClinicalTrials.gov ID
- NCT05564923
- Acronym / sponsor ID
- NIVOTOXTOOL
- Conditions
- Nivolumab Related Toxicity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Namik Kemal UniversityUniversity, hospital or other
- Study start
- 2 Sep 2022 (actual)
- Primary completion
- 17 Jun 2023 (estimated)
- Study completion
- 17 Aug 2023 (estimated)
- First posted
- 4 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Under 60 years old
- Ecog score >1
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| group 1 | – | Drug: there is no interventionAdvanced cancer patients over 65 years of age receiving nivolumab |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Advanced stage cancer patients who have been treated with nivolumab
Key inclusion criteria (2 listed)
- Advanced stage cancer patients who have been treated with nivolumab
- be over 60 years old
Key exclusion criteria (1 listed)
- be under the age of 60
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| there is no interventionthere is no intervention | Drug | group 1 |
Primary outcome
grade 3-4 nivolumab toxicity
Time frame: one year from first patient enrolled
grading will be made according to the CTCA V.6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nivolumab Related Toxicity, run by Namik Kemal University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
grade 3-4 nivolumab toxicity (time frame: one year from first patient enrolled). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2022.