Immune Checkpoint Inhibitor Toxicity (I-CHECKIT): A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,062
- 试验地点
- 849
- 主要终点
- Occurrence of severe or worse non-hematological immune-related adverse event (irAE)
研究概览
简要总结
This study examines how certain risk factors (such as age, gender, other medical conditions, and the type of immunotherapy used to treat the cancer) affect whether a patient with a malignant solid tumor will develop mild or serious side effects from the immunotherapy medications. Immunotherapy is the type of treatment that helps the body's immune system fight cancer. In the future, this information may help doctors make better decisions about cancer treatments.
详细描述
PRIMARY OBJECTIVE:
I. To both develop and independently validate a risk prediction model for Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or higher non-hematological immune-related adverse events (irAEs) in the first year of immune checkpoint inhibitor (ICI)-based therapy for the treatment of solid tumors.
SECONDARY OBJECTIVES:
I. To prospectively assess the incidence of any grade of non-hematological irAEs and grade 4 hematological irAEs on ICI-based therapy.
II. To observe the trajectory of patient-reported quality of life and health preferences over 12 months.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must be planning to receive ICI-based therapy for a solid tumor malignancy. This therapy must be given according to Food and Drug Administration (FDA) label or National Comprehensive Cancer Network (NCCN) guidelines at Category 1 or 2A and not in the context of a clinical trial
- •Participants who have received prior ICI-based therapy must have completed ICI based therapy at least 180 days prior to registration
- •Participants must not have discontinued any prior ICI-based therapy (if applicable) because of irAE
- •Participants must not have received chemotherapy, biologic, or targeted-therapy within 21 days prior to registration
- •Participants must have recovered from side effects of prior therapy to the following standards per treating physician's discretion:
- •=< Grade 1 for any non-hematologic side effects (excluding neuropathy and alopecia); lab-related parameters of liver and renal function will be considered at the discretion of the treating physician)
- •=< Grade 2 for neuropathy and/or alopecia
- •Grade 3 or less for any hematologic side effects
- •Participants must be planning to begin standard of care ICI-based therapy within 3 calendar days after registration
- •Participants must not be planning to receive ICI-based therapy in combination with chemotherapy or any other non-ICI therapy for treatment of their cancer
- •Participants must be at least 18 years of age
- •Participants must complete their history and physical examination within 28 days prior to registration
- •Participants who can complete the S2013 Feasibility Questionnaire in English or Spanish must participate at the scheduled assessments
- •Participants must be able to complete Patient-Reported Outcome (PRO) instruments in English, Spanish, or French and must be planning to complete PROs at all scheduled assessments
- •Participants must complete the pre-registration (baseline) PRO forms within 14 days prior to registration
- •Participants must be willing to participate in PRO data collection
- •Note: Prior to registration, participants must decide on their method (paper or electronic) of completing their follow-up questionnaires. Participants who elect electronic (ePRO) completion must have an iPhone, Android phone, or tablet with cellular or WiFi connectivity in order to download the Patient Cloud mobile applications onto the device (personal device or a site provisioned device for multi-users)
- •Participants must be offered the opportunity to participate in the optional specimen banking
- •Note: As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system.
- •Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines
排除标准
- 未提供
研究组 & 干预措施
Observational (biospecimen collection, questionnaire)
Patients undergo collection of a tissue sample at the start of their routine cancer treatment. Patients complete questionnaires at the start of cancer treatment, weeks 4, 12, 24, and 52. Patients will have the option of providing blood samples at several time points during the study.
干预措施: Biospecimen Collection (Procedure)
Observational (biospecimen collection, questionnaire)
Patients undergo collection of a tissue sample at the start of their routine cancer treatment. Patients complete questionnaires at the start of cancer treatment, weeks 4, 12, 24, and 52. Patients will have the option of providing blood samples at several time points during the study.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Occurrence of severe or worse non-hematological immune-related adverse event (irAE)
时间窗: 52 weeks
Adverse events will be recorded according to the physician rated Common Terminology Criteria for Adverse Events (CTCAE) scoring system.
次要结局
- Change in toxicity over time (ToxT)(Baseline to 52 weeks)
- Change in PRO-CTCAE scores(Baseline to 52 weeks)
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS)-29(Baseline to 52 weeks)
- Change in cytokine toxicity (CYTOX) score(Baseline to 1 cycle after ICI-therapy)
- Change in PROMIS Cognitive Function- Short Form 4a version 2.0 scores(Baseline to 52 weeks)