Understanding New Cachexia Subtypes Through Observational Epidemiological Research (UNCOVER)
2026年8月17日 更新者：Kaiser Permanente
The UNCOVER study is a longitudinal observational cohort focused on patients at high risk for cancer cachexia.
At Kaiser Permanente Northern California, up to 800 individuals with advanced or unresectable non-small cell lung cancer, pancreatic adenocarcinoma, or colorectal cancer will be enrolled, as these malignancies carry a substantial risk of cancer cachexia, which is characterized by progressive loss of weight, muscle, and adipose tissue, accompanied by functional decline and reduced quality of life.
Data collected includes demographic, physiologic, and clinical data, including tumor characteristics and biomarkers of inflammation, hormonal and metabolic status, body composition, physical function, and patient reported outcomes.
Investigators will identify patient phenotypes (i.e., subgroups) that may reflect distinct biological or clinical pathways underlying cancer cachexia.
By characterizing heterogeneity in cancer cachexia, this study aims to inform the development of improved diagnostic criteria and more targeted therapeutic strategies, ultimately enhancing clinical trial design and supportive care for patients with advanced colorectal, lung, or pancreatic cancer.
研究概览
地位
招聘中
详细说明
PRIMARY OBJECTIVES:
I. To identify multiple distinct diagnostic phenotypes within the syndrome of cancer cachexia as defined by host characteristics (e.g. cachexia symptoms, physical activity, physical function, blood biomarkers, and body composition) at baseline and change in these factors over time in patients with cancer at high risk for cancer cachexia.
II. To determine the association of each cancer cachexia phenotype with overall survival.
SECONDARY OBJECTIVES:
I. To determine the association of each cancer cachexia phenotype with functional decline and treatment intolerance.
II. To inform clinical practice guidelines for prompt recognition of patients likely to progress to refractory cachexia, identify early predictors apparent at clinical presentation of each cancer cachexia phenotype defined in the primary objective.
研究类型
观察性的
注册 (估计的)
800
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Elizabeth M Cespedes Feliciano, ScD, SM
- 电话号码：(510) 414-4154
- 邮箱：Elizabeth.M.Cespedes@kp.org
研究联系人备份
- 姓名：Michelle C Ross, MPH
- 电话号码：(925) 520-0650
- 邮箱：michelle.c.ross@kp.org
学习地点
-
-
California
-
Pleasanton、California、美国、94588
- 招聘中
- Kaiser Permanente Northern California
-
接触：
- Michelle C Ross, MPH
- 电话号码：(925) 520-0650
- 邮箱：michelle.c.ross@kp.org
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
取样方法
非概率样本
研究人群
Patients undergoing treatment for non-small cell lung cancer (NSCLC), pancreatic adenocarcinoma, or colorectal cancer.
描述
Inclusion Criteria:
- Have a primary diagnosis of unresectable or Stage IV 1) non-small cell lung cancer (NSCLC), 2) pancreatic adenocarcinoma, or 3) colorectal cancer (CRC).
Note: Patients do not need to have cachexia to be eligible
- Plan to start first line systemic anti-cancer therapy (chemotherapy, immunotherapy, targeted therapy) in the next 6 weeks or has started first-line systemic therapy in the previous 6 weeks.
Note: Patients who received systemic anti-cancer therapy previously as part of adjuvant or neoadjuvant therapy and have since recurred are still eligible if such treatment was longer than 6 months prior to enrollment.
- Have an an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
- Be able to understand, speak and read English.
- Be 18 years or older
Exclusion Criteria:
- Have contraindications to physical function assessments (30-second bicep curl, Timed-Up-And-Go test, or 30-Second Sit to Stand test) per the treating provider or their designee.
- Have any planned major surgeries within the next 3 months after enrollment to the best knowledge of the investigator/treating provider or their designee.
- Have received chemotherapy or surgery for separate primary cancer within the past 3 years other than non-melanoma skin cancer.
- Be pregnant or within 6 months postpartum.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Observational (survey, function tests, biospecimen, actigraphy)
Patients complete surveys, undergo physical function tests, undergo collection of blood and archived tumor samples, and wear an actigraph over 24 hours for a week to record daily sleep and exercise activity at baseline and 3-month follow-up.
A sub-sample of patients provide stool samples.
Additionally, patients undergo standard of care CT or PET/CT scans throughout the study and patients' medical records are also reviewed at baseline, 3-month and 1-year follow-up.
|
完成调查
接受 CT 或 PET/CT 扫描
其他名称：
佩戴动作法
Undergo collection of blood and archived tumor samples.
A sub-sample undergo collection of stool samples.
其他名称：
Electronic Health Record Review
Undergo physical function assessments including 30-second bicep curl, timed up and go (TUG), and 30-second sit to stand
其他名称：
Undergo PET/CT scan
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Multiple distinct diagnostic cancer cachexia phenotypes
大体时间：Baseline through study completion, assessed up to 1 year follow up
|
Phenotypes will be based on patient-reported symptoms, physical activity and function assessments, biomarkers, and body composition measured longitudinally using latent class analysis and other clustering methods.
|
Baseline through study completion, assessed up to 1 year follow up
|
|
Overall survival: time to death
大体时间：Baseline to death (the event) or the last contact (censored), assessed up to 1 year follow up
|
Time to death will be assessed as the interval between phenotype ascertainment and death from any cause.
Participants without a recorded death event will be censored at the end of available follow-up (e.g., end of health plan membership or the study observation period).
|
Baseline to death (the event) or the last contact (censored), assessed up to 1 year follow up
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Functional decline
大体时间：Baseline through study completion, assessed up to 1 year follow up
|
Associations between each cancer cachexia phenotype and functional decline is a secondary outcome.
Functional status will be measured at baseline and study completion by physical function assessments and patient-reported questionnaires.
|
Baseline through study completion, assessed up to 1 year follow up
|
|
Treatment intolerance
大体时间：Baseline through study completion, assessed up to 1 year follow up
|
Treatment intolerance will be modeled as time to event outcomes.
Treatment data including chemotherapy, targeted therapy, and immunotherapy will be obtained from the electronic medical record.
|
Baseline through study completion, assessed up to 1 year follow up
|
|
Early predictors of decline
大体时间：Baseline through study completion, assessed up to 1 year follow up
|
Logistic regression will be used to identify patient characteristics apparent at clinical presentation that are early predictors of each cancer cachexia phenotype, focusing on the high-risk phenotypes that are associated with poor outcomes.
|
Baseline through study completion, assessed up to 1 year follow up
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
有用的网址
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2023年4月5日
初级完成 (估计的)
2027年5月1日
研究完成 (估计的)
2028年5月1日
研究注册日期
首次提交
2026年8月17日
首先提交符合 QC 标准的
2026年8月17日
首次发布 (实际的)
2026年8月20日
研究记录更新
最后更新发布 (实际的)
2026年8月20日
上次提交的符合 QC 标准的更新
2026年8月17日
最后验证
2026年7月1日
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- 1927206
- OT2CA278691 (美国 NIH 拨款/合同)
- CGCATF-2021/100033 (其他赠款/资助编号：Cancer Research UK)
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.