Geriatric OncologyNCT07151794
G8, CARG, Frailty, and Nutritional Markers in Predicting Chemotoxicity
An observational study of Geriatric Oncology and Oncology, run by Çanakkale Onsekiz Mart University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the ability of G8, CARG, and Frailty scales to predict chemotherapy-related toxicity and the need for G-CSF in elderly cancer patients. It also investigates their correlation with nutritional biomarkers (albumin, prealbumin, hemoglobin, CRP) and the Mini Nutritional Assessment (MNA) test. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Geriatric Oncology, Oncology, Nutrition
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2025to Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: The study group consists of cancer patients aged 65 and older who are scheduled to receive at least two cycles of chemotherapy. Patients with hematological malignancies or receiving concurrent targeted, hormonal, immunotherapy, or radiotherapy are excluded.
Who may be able to join
- Age ≥ 65 years
- Diagnosed with solid tumor malignancy
- Planned to undergo at least two cycles of adjuvant, neoadjuvant, or metastatic chemotherapy
- Clinically stable condition
- Provided written informed consent
Who cannot join
- Presence of hematological malignancies
- Concurrent hormonal therapy, targeted therapy, immunotherapy, or radiotherapy
- Acute infection or advanced organ failure (cardiac, hepatic, renal)
- Cognitive or psychiatric impairment preventing test participation
- Prior treatment with G-CSF
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Çanakkale Onsekiz Mart Univercity
Çanakkale, 17020
About this study
Official title: Correlation of G8, CARG, and Frailty Scales With Nutritional Biomarkers and G-CSF Requirement in Elderly Cancer Patients: A Prospective Study on Predicting Chemotherapy Toxicity
This study aims to evaluate the ability of G8, CARG, and Frailty scales to predict chemotherapy-related toxicity and the need for G-CSF in elderly cancer patients. It also investigates their correlation with nutritional biomarkers (albumin, prealbumin, hemoglobin, CRP) and the Mini Nutritional Assessment (MNA) test.
Read the detailed description
Background: Aging is associated with decreased physiological reserves, making elderly cancer patients more vulnerable to chemotherapy toxicity (CT). Traditional performance scales like ECOG may be insufficient for treatment decisions. Tools such as G8, Clinical Frailty Scale (CFS), and the Cancer and Aging Research Group (CARG) score are practical screening instruments recommended by ASCO and SIOG, yet their combined predictive accuracy for CT and granulocyte colony-stimulating factor (G-CSF) usage remains underexplored.
Objectives: This prospective study aims to evaluate the predictive performance of the G8, CARG, and Frailty scales-alone and in combination with nutritional biomarkers (albumin, prealbumin, hemoglobin, CRP)-in forecasting chemotherapy-related toxicity and G-CSF need. It also investigates the correlation between these geriatric assessment tools and Mini Nutritional Assessment (MNA) scores.
Methods: The study will be conducted at Çanakkale University Medical Faculty Oncology Outpatient Clinic. Patients aged 65 and above with a planned chemotherapy regimen will be recruited. Before the first chemotherapy cycle, patients will undergo G8, CARG, Frailty, and MNA assessments. Nutritional biomarkers will be extracted from pre-treatment routine lab tests. Chemotherapy toxicity and G-CSF requirement will be monitored across treatment cycles. ROC, correlation, and regression analyses will be conducted to evaluate predictive validity.
- Conditions
- Geriatric Oncology, Oncology, Nutrition, Nutrition Assessment
- Keywords
- G-CSF, CARG, Frailty, Mini Nutritional Assessment (MNA)
- Medical subject headings
- Neoplasms, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | The study group consists of cancer patients aged 65 and older who are scheduled to receive at least two cycles of chemotherapy. Patients with hematological malignancies or receiving concurrent targeted, hormonal, immunotherapy, or radiotherapy are excluded. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Side effects of chemotherapy
Measured: From enrollment to 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start2 Jan 2025
- Primary completionDec 2025 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Geriatric OncologyStudies 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
- Çanakkale Onsekiz Mart University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cemre Aydeğer, Çanakkale Onsekiz Mart University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07151794
- Sponsor's protocol ID
- COMU-FNO-2
- Status last verified
- Jan 2025
- First submitted
- 31 Jul 2025
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bellera CA, Rainfray M, Mathoulin-Pelissier S, Mertens C, Delva F, Fonck M, Soubeyran PL. Screening older cancer patients: first evaluation of the G-8 geriatric screening tool. Ann Oncol. 2012 Aug;23(8):2166-2172. doi: 10.1093/annonc/mdr587. Epub 2012 Jan 16.
PubMed 22250183Church S, Rogers E, Rockwood K, Theou O. A scoping review of the Clinical Frailty Scale. BMC Geriatr. 2020 Oct 7;20(1):393. doi: 10.1186/s12877-020-01801-7.
PubMed 33028215Kenis, C., Bron, D., Libert, Y., et al., Relevance of a geriatric assessment in older patients with cancer: a systematic review, Journal of Geriatric Oncology, 2014, 5(2): 3-9.
Decoster L, Van Puyvelde K, Mohile S, Wedding U, Basso U, Colloca G, Rostoft S, Overcash J, Wildiers H, Steer C, Kimmick G, Kanesvaran R, Luciani A, Terret C, Hurria A, Kenis C, Audisio R, Extermann M. Screening tools for multidimensional health problems warranting a geriatric assessment in older cancer patients: an update on SIOG recommendationsdagger. Ann Oncol. 2015 Feb;26(2):288-300. doi: 10.1093/annonc/mdu210. Epub 2014 Jun 16.
PubMed 24936581Wildiers, H., Heeren, P., Puts, M., et al., Comprehensive geriatric assessment (CGA) in older patients with cancer: facts and future, The Lancet Oncology, 2014, 15(5): e184-e192.
Hurria A, Togawa K, Mohile SG, Owusu C, Klepin HD, Gross CP, Lichtman SM, Gajra A, Bhatia S, Katheria V, Klapper S, Hansen K, Ramani R, Lachs M, Wong FL, Tew WP. Predicting chemotherapy toxicity in older adults with cancer: a prospective multicenter study. J Clin Oncol. 2011 Sep 1;29(25):3457-65. doi: 10.1200/JCO.2011.34.7625. Epub 2011 Aug 1.
PubMed 21810685
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of G8, CARG, and Frailty Scales With Nutritional Biomarkers and G-CSF Requirement in Elderly Cancer Patients: A Prospective Study on Predicting Chemotherapy Toxicity
- ClinicalTrials.gov ID
- NCT07151794
- Acronym / sponsor ID
- COMU-FNO-2
- Conditions
- Geriatric Oncology, Oncology, Nutrition, Nutrition Assessment
- Keywords
- G-CSF, CARG, Frailty, Mini Nutritional Assessment (MNA)
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Çanakkale Onsekiz Mart UniversityUniversity, hospital or other
- Study start
- 2 Jan 2025 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 3 Sep 2025 (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.
This study aims to evaluate the ability of G8, CARG, and Frailty scales to predict chemotherapy-related toxicity and the need for G-CSF in elderly cancer patients. It also investigates their correlation with nutritional biomarkers (albumin, prealbumin, hemoglobin, CRP) and the Mini Nutritional Assessment (MNA) test.
Detailed description
Background: Aging is associated with decreased physiological reserves, making elderly cancer patients more vulnerable to chemotherapy toxicity (CT). Traditional performance scales like ECOG may be insufficient for treatment decisions. Tools such as G8, Clinical Frailty Scale (CFS), and the Cancer and Aging Research Group (CARG) score are practical screening instruments recommended by ASCO and SIOG, yet their combined predictive accuracy for CT and granulocyte colony-stimulating factor (G-CSF) usage remains underexplored.
Objectives: This prospective study aims to evaluate the predictive performance of the G8, CARG, and Frailty scales-alone and in combination with nutritional biomarkers (albumin, prealbumin, hemoglobin, CRP)-in forecasting chemotherapy-related toxicity and G-CSF need. It also investigates the correlation between these geriatric assessment tools and Mini Nutritional Assessment (MNA) scores.
Methods: The study will be conducted at Çanakkale University Medical Faculty Oncology Outpatient Clinic. Patients aged 65 and above with a planned chemotherapy regimen will be recruited. Before the first chemotherapy cycle, patients will undergo G8, CARG, Frailty, and MNA assessments. Nutritional biomarkers will be extracted from pre-treatment routine lab tests. Chemotherapy toxicity and G-CSF requirement will be monitored across treatment cycles. ROC, correlation, and regression analyses will be conducted to evaluate predictive validity.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –The study group consists of cancer patients aged 65 and older who are scheduled to receive at least two cycles of chemotherapy. Patients with hematological malignancies or receiving concurrent targeted, hormonal, immunotherapy, or radiotherapy are excluded. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- The study group consists of cancer patients aged 65 and older who are scheduled to receive at least two cycles of chemotherapy. Patients with hematological malignancies or receiving concurrent targeted, hormonal, immunotherapy, or radiotherapy are excluded.
Key inclusion criteria (5 listed)
- Age ≥ 65 years
- Diagnosed with solid tumor malignancy
- Planned to undergo at least two cycles of adjuvant, neoadjuvant, or metastatic chemotherapy
- Clinically stable condition
- Provided written informed consent
Key exclusion criteria (5 listed)
- Presence of hematological malignancies
- Concurrent hormonal therapy, targeted therapy, immunotherapy, or radiotherapy
- Acute infection or advanced organ failure (cardiac, hepatic, renal)
- Cognitive or psychiatric impairment preventing test participation
- Prior treatment with G-CSF
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Side effects of chemotherapy
Time frame: From enrollment to 6 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Background: PubMed 22250183Bellera CA, Rainfray M, Mathoulin-Pelissier S, Mertens C, Delva F, Fonck M, Soubeyran PL. Screening older cancer patients: first evaluation of the G-8 geriatric screening tool. Ann Oncol. 2012 Aug;23(8):2166-2172. doi: 10.1093/annonc/mdr587. Epub 2012 Jan 16.
- Background: PubMed 33028215Church S, Rogers E, Rockwood K, Theou O. A scoping review of the Clinical Frailty Scale. BMC Geriatr. 2020 Oct 7;20(1):393. doi: 10.1186/s12877-020-01801-7.
- BackgroundKenis, C., Bron, D., Libert, Y., et al., Relevance of a geriatric assessment in older patients with cancer: a systematic review, Journal of Geriatric Oncology, 2014, 5(2): 3-9.
- Background: PubMed 24936581Decoster L, Van Puyvelde K, Mohile S, Wedding U, Basso U, Colloca G, Rostoft S, Overcash J, Wildiers H, Steer C, Kimmick G, Kanesvaran R, Luciani A, Terret C, Hurria A, Kenis C, Audisio R, Extermann M. Screening tools for multidimensional health problems warranting a geriatric assessment in older cancer patients: an update on SIOG recommendationsdagger. Ann Oncol. 2015 Feb;26(2):288-300. doi: 10.1093/annonc/mdu210. Epub 2014 Jun 16.
- BackgroundWildiers, H., Heeren, P., Puts, M., et al., Comprehensive geriatric assessment (CGA) in older patients with cancer: facts and future, The Lancet Oncology, 2014, 15(5): e184-e192.
- Background: PubMed 21810685Hurria A, Togawa K, Mohile SG, Owusu C, Klepin HD, Gross CP, Lichtman SM, Gajra A, Bhatia S, Katheria V, Klapper S, Hansen K, Ramani R, Lachs M, Wong FL, Tew WP. Predicting chemotherapy toxicity in older adults with cancer: a prospective multicenter study. J Clin Oncol. 2011 Sep 1;29(25):3457-65. doi: 10.1200/JCO.2011.34.7625. Epub 2011 Aug 1.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Geriatric Oncology and Oncology, run by Çanakkale Onsekiz Mart 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 5 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 3 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Side effects of chemotherapy (time frame: From enrollment to 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07151794, which also lists 6 linked publications.
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 3 Sep 2025.