Predicting Chemotherapy Related Toxicity in Elderly PatientsNCT04992455
G8, VES-13 and CARG Scores in Predicting Chemotherapy Toxicity in Geriatric Cancer Patients
An observational study of Predicting Chemotherapy Related Toxicity in Elderly Patients, run by Namik Kemal University at 1 site in Turkey (Türkiye).
Trial summary
All participants' medical information will be collected for use as a baseline, including tumor-specific variables, nutritional status, functional status, psychological status, cognitive function, social support, and comorbidities. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Predicting Chemotherapy Related Toxicity in Elderly Patients
- What is being tested?
- Older Patients Receiving Chemotherapy
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2021to 1 Sep 2021
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Older Patients Receiving Chemotherapy
Who may be able to join
- Aged ≥65 years
- Localized or metastatic solid carcinoma diagnosed by histology (any type, any stage)
- Starting a new-line (first-line, second-line or third-line) chemotherapy
Who cannot join
- Concurrent radiotherapy;
- Simultaneous immunotherapy
- Impaired language
- Cognitive function leading to inability to complete assessments.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Predictive Value of G8, VES-13 and CARG Scores in Treatment-related Toxicity in Geriatric Cancer Patients
All participants' medical information will be collected for use as a baseline, including tumor-specific variables, nutritional status, functional status, psychological status, cognitive function, social support, and comorbidities. The suitability of G8, VES-13 and CARG chemotherapy risk assessment tools for elderly cancer patients was investigated.
Read the detailed description
All participants' medical information will be collected for use as a baseline, including tumor-specific variables, nutritional status, functional status, psychological status, cognitive function, social support, and comorbidities. G8, VES-13 and CARG toxicity scores of all participating patients will be determined by two independent investigators before starting chemotherapy. The suitability of these practical chemotherapy risk assessment tools for cancer patients for elderly cancer patients was investigated.
- Being tested
- Older Patients Receiving Chemotherapy
- Keywords
- g8, ves-13, CARG, chemotherapy-related toxicity, Toxicity tool
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Older Patients Receiving ChemotherapyOther
No Intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
G8 (Geriatric 8) screening tool measurement
Measured: 15-30 minutes
CARG (Cancer and Aging Research Group) chemotherapy toxicity score measurement
Measured: 30-60 minutes
VES-13 (Vulnerable Elders Survey-13) measurement
Measured: 30-60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start1 Feb 2021
- Primary completion1 Sep 2021 (estimated)
- Study completion1 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Predicting Chemotherapy Related Toxicity in Elderly PatientsStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 150 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
- Investigators
- Erdoğan S Şeber, Assoc. Prof., Study chair, Namik Kemal UniversityEyyüp Çavdar, MD, Study director, Namik Kemal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04992455
- Sponsor's protocol ID
- CHEMOTOXTOOL
- Status last verified
- Aug 2021
- First submitted
- 1 Aug 2021
- Last updated
- 5 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Predictive Value of G8, VES-13 and CARG Scores in Treatment-related Toxicity in Geriatric Cancer Patients
- ClinicalTrials.gov ID
- NCT04992455
- Acronym / sponsor ID
- CHEMOTOXTOOL
- Keywords
- g8, ves-13, CARG, chemotherapy-related toxicity, Toxicity tool
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Namik Kemal UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 5 Aug 2021 (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.
All participants' medical information will be collected for use as a baseline, including tumor-specific variables, nutritional status, functional status, psychological status, cognitive function, social support, and comorbidities. The suitability of G8, VES-13 and CARG chemotherapy risk assessment tools for elderly cancer patients was investigated.
Detailed description
All participants' medical information will be collected for use as a baseline, including tumor-specific variables, nutritional status, functional status, psychological status, cognitive function, social support, and comorbidities. G8, VES-13 and CARG toxicity scores of all participating patients will be determined by two independent investigators before starting chemotherapy. The suitability of these practical chemotherapy risk assessment tools for cancer patients for elderly cancer patients was investigated.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Older Patients Receiving Chemotherapy
Key inclusion criteria (3 listed)
- Aged ≥65 years
- Localized or metastatic solid carcinoma diagnosed by histology (any type, any stage)
- Starting a new-line (first-line, second-line or third-line) chemotherapy
Key exclusion criteria (4 listed)
- Concurrent radiotherapy;
- Simultaneous immunotherapy
- Impaired language
- Cognitive function leading to inability to complete assessments.
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 |
|---|---|---|
| Older Patients Receiving ChemotherapyNo Intervention | Other | – |
Primary outcome
G8 (Geriatric 8) screening tool measurement
Time frame: 15-30 minutes
CARG (Cancer and Aging Research Group) chemotherapy toxicity score measurement
Time frame: 30-60 minutes
VES-13 (Vulnerable Elders Survey-13) measurement
Time frame: 30-60 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2021.
- Individual participant dataSharing planned: Undecided
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.
Erdoğan S Şeber, Assoc. Prof. study chair
Namik Kemal University
Eyyüp Çavdar, MD study director
Namik Kemal University
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 Predicting Chemotherapy Related Toxicity in Elderly Patients, 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 3 inclusion and 4 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 5 Aug 2021. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
G8 (Geriatric 8) screening tool measurement (time frame: 15-30 minutes). The study lists 3 primary outcomes in all. 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 5 Aug 2021.