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临床试验/NCT05106374
NCT05106374已完成不适用

FITNESS: Calculating Risk of Chemotherapy Toxicity in Older Adults

Ohio State University Comprehensive Cancer Center1 个研究点 分布在 1 个国家目标入组 182 人开始时间: 2018年9月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
182
试验地点
1
主要终点
Prognostic ability of the CARG chemotoxicity calculator in patients newly diagnosed with hematologic malignancy

研究概览

简要总结

This trial evaluates the risk of chemotherapy toxicity in older patients with blood cancer or non-small cell lung cancer. The purpose of this study is to describe a patient's wellness before and after chemotherapy treatment. This may help researchers better understand patient's ability to tolerate treatment and in the future devise the best treatment for a patient based on their "fitness."

详细描述

PRIMARY OBJECTIVE:

I. To validate the accuracy and predictive ability of the Cancer and Aging Research Group (CARG) Chemo-Toxicity calculator in untreated patients with hematologic malignancy and non-small cell lung cancer, as well as relapsed patients with a hematologic malignancy intended to begin chimeric antigen receptor (CAR) T cell therapy.

Ia. Determine if the CARG Chemo-Toxicity calculator predicts grade 3-5 toxicity in older adult patients with hematologic malignancy undergoing treatment.

Ib. Determine if CARG Geriatric Assessment (GA) metrics predict grade 3-5 toxicity in older adults with hematologic malignancy undergoing treatment.

Ic. Identify the association between frailty metrics and relative dose intensity in older adults with hematologic malignancy.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Untreated for a hematologic malignancy or NSCLC malignancy with intention to receive treatment (i.e., chemotherapy, immunotherapy, targeted agents, bone marrow transplant, or other) at the Ohio State University; or patients with a relapsed hematologic malignancy intended to begin CAR T cell therapy
  • Ability to understand and willingness to sign an informed consent document (or indicate approval or disapproval by another means)

排除标准

  • Prisoners are excluded from participation
  • Any medical condition including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness that would limit compliance with study procedures

研究组 & 干预措施

Observational (questionnaire, assessment, biospecimen)

Patients complete questionnaires over 30-40 minutes about daily activity and feelings, complete thinking and walking tests over 10 minutes, and undergo collection of blood samples before the first dose of chemotherapy and 90, 180, and 365 days after first dose of chemotherapy. Patients with non-small lung cancer also undergo collection of stool sample.

干预措施: Quality-of-Life Assessment (Other)

Observational (questionnaire, assessment, biospecimen)

Patients complete questionnaires over 30-40 minutes about daily activity and feelings, complete thinking and walking tests over 10 minutes, and undergo collection of blood samples before the first dose of chemotherapy and 90, 180, and 365 days after first dose of chemotherapy. Patients with non-small lung cancer also undergo collection of stool sample.

干预措施: Biospecimen Collection (Procedure)

Observational (questionnaire, assessment, biospecimen)

Patients complete questionnaires over 30-40 minutes about daily activity and feelings, complete thinking and walking tests over 10 minutes, and undergo collection of blood samples before the first dose of chemotherapy and 90, 180, and 365 days after first dose of chemotherapy. Patients with non-small lung cancer also undergo collection of stool sample.

干预措施: Cognitive Assessment (Procedure)

Observational (questionnaire, assessment, biospecimen)

Patients complete questionnaires over 30-40 minutes about daily activity and feelings, complete thinking and walking tests over 10 minutes, and undergo collection of blood samples before the first dose of chemotherapy and 90, 180, and 365 days after first dose of chemotherapy. Patients with non-small lung cancer also undergo collection of stool sample.

干预措施: Physical Performance Testing (Other)

Observational (questionnaire, assessment, biospecimen)

Patients complete questionnaires over 30-40 minutes about daily activity and feelings, complete thinking and walking tests over 10 minutes, and undergo collection of blood samples before the first dose of chemotherapy and 90, 180, and 365 days after first dose of chemotherapy. Patients with non-small lung cancer also undergo collection of stool sample.

干预措施: Questionnaire Administration (Other)

结局指标

主要结局

Prognostic ability of the CARG chemotoxicity calculator in patients newly diagnosed with hematologic malignancy

时间窗: 365 days after first dose of chemotherapy

Predictive ability of Chemo-Toxicity calculator to predict grade 3-5 toxicity

时间窗: 365 days after first dose of chemotherapy

Will fit a Cox regression model for time to toxicity (grades 3-5) containing the baseline chemo-toxicity risk score as the only predictor. The overall ability of the model to distinguish grade 3-5 from grade 1-2 toxicity will be evaluated using Harrell's C-statistic, which can be viewed as a generalization of the area under the curve measurement for receiver operator characteristics (ROC's) curves based on binary outcome data. A 95% confidence interval will be constructed for the C-statistic and if the lower bound is greater than 0.5 (expected value if the risk score is not predictive of toxicity) we will conclude that risk score is significantly able to distinguish between toxicity grades.

Predictive ability of Geriatric Assessment (GA) metrics to predict grade 3-5 toxicity

时间窗: 365 days after first dose of chemotherapy

Will fit a Cox regression model for time to toxicity (grades 3-5) containing the baseline chemo-toxicity risk score as the only predictor. The overall ability of the model to distinguish grade 3-5 from grade 1-2 toxicity will be evaluated using Harrell's C-statistic, which can be viewed as a generalization of the area under the curve measurement for ROC's curves based on binary outcome data. A 95% confidence interval will be constructed for the C-statistic and if the lower bound is greater than 0.5 (expected value if the risk score is not predictive of toxicity) we will conclude that risk score is significantly able to distinguish between toxicity grades.

Predictive ability of the Cancer and Aging Research Group (CARG) Chemo-Toxicity calculator

时间窗: 365 days after first dose of chemotherapy

Association between frailty metrics and relative dose intensity (RDI)

时间窗: 365 days after first dose of chemotherapy

Will explore the relationship of RDI and MAX2 (reduced and prescribed) with clinical and biologic factors of frailty. RDI (\>= 85% versus \[vs.\] \< 85%) will be treated as a continuous and dichotomous variable. The distribution of RDI and MAX2 will be examined graphically and transformed to normality as appropriate. Linear regression for continuous RDI and logistic regression for dichotomized RDI will be used to understand the relationship with RDI and independent variables (e.g. GA scores, age, short physical performance battery \[SPPB\] etc.) Stepwise regression will be used to identify significant clinical and biologic factors (e.g. OSU\_Senescence) that are independently associated with continuous or dichotomized RDI.

次要结局

  • Relationship of frailty metrics with health related quality of life over time(365 days after first dose of chemotherapy)
  • Molecular markers of aging with risk of chemotherapy toxicity using the Chemo-Toxicity calculator(365 days after first dose of chemotherapy)
  • Relationship of frailty metrics with physical function(365 days after first dose of chemotherapy)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ashley Rosko

Principal Investigator

Ohio State University Comprehensive Cancer Center

研究点 (1)

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