Point of care, real-time urine metabolomics test to diagnose colorectal cancers and polyps in low- and middle-income countries
护理点实时尿液代谢组学测试可诊断低收入和中等收入国家的结直肠癌和息肉
基本信息
- 批准号:10173098
- 负责人:
- 金额:$ 76.7万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2017
- 资助国家:美国
- 起止时间:2017-04-15 至 2023-04-30
- 项目状态:已结题
- 来源:
- 关键词:Advanced Malignant NeoplasmAdvisory CommitteesAge-YearsAlberta provinceBedside TestingsBeliefBenignBiological AssayBiosensorBusinessesCanadaCancer ControlCancer DiagnosticsClinical TrialsClinics and HospitalsColonoscopyColorectal CancerColorectal PolypCost Effectiveness AnalysisCountryDNADataDatabasesDeath RateDevelopmentDevice or Instrument DevelopmentDevicesDiagnosisDiagnostic testsDiseaseEndoscopyEngineeringEnsureExcisionExposure toFamily history ofFecesGoalsGrantGuidelinesHealth PrioritiesHealth systemHemorrhageHospitalsIncidenceIncomeIndustryMalignant NeoplasmsMarketingMeasuresMedical DeviceMedical centerMedicineMicrofluidic MicrochipsModalityMorbidity - disease rateNigeriaNigerianNuclear Magnetic ResonanceOutcomePatient-Focused OutcomesPatientsPhasePhysiciansPolypsPopulationPrecancerous PolypPriceProspective StudiesPublic HealthRecording of previous eventsResearchResearch PersonnelRiskRisk FactorsScientistShipsSpecificitySpecimenTeaching HospitalsTechnologyTestingTimeUnited NationsUnited States National Institutes of HealthUniversitiesUpdateUrineValidationWorld Health Organizationadvanced diseasebasebiobankcancer carecancer diagnosiscollegecolon cancer patientscolorectal cancer preventioncolorectal cancer riskcolorectal cancer screeningcommercializationcostcost effectivefollow-uphigh risklow and middle-income countriesmetabolomicsmicrocostingmortalitypatient stratificationpoint of carepoint-of-care diagnosticsportabilitypremalignantpreventprogramsprospectiverectalscreeningtime usevalidation studies
项目摘要
PROJECT SUMMARY/ABSTRACT
Colorectal cancer (CRC) has become a major public health issue in low- and middle-income countries (LMIC);
globally, it is the third most common cancer. Colorectal cancer rates are rising in LMICs. Outcomes of patients
with CRC are poor in LMICs, largely because patients have advanced disease. Colorectal cancer screening
lowers mortality by identifying precancerous polyps (which can be removed) and diagnosing cancer at an early
stage. In high-income countries (HIC), screening modalities include stool-based tests and endoscopies. Due to
cost, high incidence of benign rectal bleeding, limited access, and lack of point of care (POC) options, these
tests are rarely used in LMICs. The large majority of patients at high-risk for CRC in LMIC do not undergo any
CRC testing. Thus, there is an unmet need for a cost-effective CRC diagnostic to identify patients at
higher risk for CRC and polyps, thereby minimizing the number of costly negative colonoscopies.
We propose using the research network we have built in Nigeria to implement a unique urine-based POC
metabolomics test that can be performed in centers in LMICs to diagnose patients with early-stage CRC and/or
precancerous polyps. Our goal is to validate our sensitive, affordable handheld biosensor device. We have
shown that our 14-metabolite urine test sensitivity is 82.3% for polyp diagnosis and 95% for CRC diagnosis.
During the UG3 phase, using urine from 450 Nigerian patients (150 with CRC, 150 with polyps, and 150 with
normal colons), we will refine our metabolite signature to 3 metabolites and modify the biosensor to make it
highly sensitive for Nigerian patients. During the UH3 phase, we will pilot test the biosensor device in Nigeria
with 75 patients with CRC, polyps, and normal colons. We will then use the POC in real-time on urine from 645
patients >40 years of age with rectal bleeding, with a family history of CRC, or with a personal diagnosis of
CRC. All patients will then receive a colonoscopy. Microcosting will be conducted to inform a cost-effective
analysis, based on World Health Organization thresholds for cost-effective or very cost-effective, of the POC
testing for each study group at the current projected price. Finally, we will determine beliefs and barriers
related to urine testing for CRC.
Our team is comprised of experts in CRC screening and management in HICs and LMICs (Memorial Sloan
Kettering [MSK], Obafemi Awolowo University [OAU], and University of Alberta [UA]). Memorial Sloan Kettering
and OAU have collaborated on 2 prospective studies. We also have experts in metabolomics, engineering,
development of biosensor POC tests, and manufacturing and marketing of medical devices (UA and
Metabolomics Technologies, Inc.). To ensure the device is appropriate for the Nigerian health system and
global CRC guidelines, we have created an advisory committee with cancer care, CRC screening, and medical
device development experts. Our POC biosensor will reduce CRC mortality in LMICs, where there are
currently no alternatives.
项目摘要/摘要
结直肠癌(CRC)已成为中低收入国家(LMIC)的主要公共卫生问题;
在全球范围内,它是第三种最常见的癌症。LMIC中的结直肠癌发病率正在上升。病人的转归
结直肠癌患者的LMIC较差,很大程度上是因为患者患有晚期疾病。结直肠癌筛查
通过识别癌前息肉(可以切除)并及早诊断癌症来降低死亡率
舞台。在高收入国家,筛查方式包括基于粪便的检测和内窥镜检查。由于
成本、良性直肠出血的高发生率、有限的通路以及缺乏护理点(POC)选项,这些因素
测试很少在LMIC中使用。在LMIC中,绝大多数结直肠癌高危患者没有接受任何
CRC测试。因此,对具有成本效益的CRC诊断以识别患者的需求尚未得到满足
结直肠癌和息肉的风险更高,从而最大限度地减少昂贵的阴性结肠镜检查的数量。
我们建议使用我们在尼日利亚建立的研究网络来实施独特的基于尿液的POC
可以在LMICs的中心进行的代谢组学测试,以诊断早期结直肠癌和/或患者
癌前息肉。我们的目标是验证我们灵敏、实惠的手持生物传感器设备。我们有
我们的14代谢物尿检对息肉诊断的敏感性为82.3%,对结直肠癌的诊断敏感性为95%。
在UG3阶段,使用450名尼日利亚患者的尿液(150名结直肠癌患者,150名息肉患者和150名
,我们将把我们的代谢物特征提炼为3种代谢物,并修改生物传感器以使其
对尼日利亚患者高度敏感。在UH3阶段,我们将在尼日利亚对生物传感器设备进行试点测试
75例结直肠癌、息肉和正常结肠患者。然后,我们将对645起的尿液实时使用PoC
40岁有直肠出血、有结直肠癌家族史或个人诊断为结直肠癌的患者。
CRC。然后所有患者都将接受结肠镜检查。将进行微观成本计算,以告知具有成本效益的
基于世界卫生组织对具有成本效益或非常成本效益的POC的阈值的分析
按当前预计价格为每个研究小组进行测试。最后,我们将确定信念和障碍
与结直肠癌的尿液检测有关。
我们的团队由HIC和LMIC(纪念斯隆)的CRC筛查和管理专家组成
凯特林[MSK]、Obafemi Awolowo大学[非统组织]和艾伯塔大学[UA])。纪念斯隆·凯特林
和非统组织合作进行了两项前瞻性研究。我们也有代谢组学、工程学、
开发生物传感器POC测试,以及医疗器械的制造和营销(UA和
代谢组学技术公司)。以确保该设备适用于尼日利亚的卫生系统,并
根据全球CRC指南,我们创建了一个咨询委员会,负责癌症护理、CRC筛查和医疗
设备开发专家。我们的POC生物传感器将降低LMIC中的CRC死亡率,
目前没有其他选择。
项目成果
期刊论文数量(0)
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科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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{{ truncateString('OLUSEGUN ISAAC ALATISE', 18)}}的其他基金
Expanding cancer research capacity in Nigeria with team science
通过团队科学扩大尼日利亚的癌症研究能力
- 批准号:
10438142 - 财政年份:2022
- 资助金额:
$ 76.7万 - 项目类别:
Expanding cancer research capacity in Nigeria with team science
通过团队科学扩大尼日利亚的癌症研究能力
- 批准号:
10588180 - 财政年份:2022
- 资助金额:
$ 76.7万 - 项目类别:
Determining the risk factor profile and biology of colorectal cancer in Nigeria
确定尼日利亚结直肠癌的危险因素概况和生物学
- 批准号:
10630075 - 财政年份:2020
- 资助金额:
$ 76.7万 - 项目类别:
Collecting whole genome sequence data to enhance the value of the first multi-center study of colorectal cancer risk factors and biology in Nigeria
收集全基因组序列数据,以提高尼日利亚首个结直肠癌危险因素和生物学多中心研究的价值
- 批准号:
10629701 - 财政年份:2020
- 资助金额:
$ 76.7万 - 项目类别:
Mentoring a Nigerian junior investigator with a mixed-methods analysis of barriers to colorectal cancer presentation in Nigeria
指导一名尼日利亚初级研究员对尼日利亚结直肠癌表现的障碍进行混合方法分析
- 批准号:
10623852 - 财政年份:2020
- 资助金额:
$ 76.7万 - 项目类别:
Determining the risk factor profile and biology of colorectal cancer in Nigeria
确定尼日利亚结直肠癌的危险因素概况和生物学
- 批准号:
10398938 - 财政年份:2020
- 资助金额:
$ 76.7万 - 项目类别:
Determining the risk factor profile and biology of colorectal cancer in Nigeria
确定尼日利亚结直肠癌的危险因素概况和生物学
- 批准号:
10227199 - 财政年份:2020
- 资助金额:
$ 76.7万 - 项目类别:
Determining the risk factor profile and biology of colorectal cancer in Nigeria
确定尼日利亚结直肠癌的危险因素概况和生物学
- 批准号:
10053881 - 财政年份:2020
- 资助金额:
$ 76.7万 - 项目类别:
Point of care, real-time urine metabolomics test to diagnose colorectal cancers and polyps in low- and middle-income countries
护理点实时尿液代谢组学测试可诊断低收入和中等收入国家的结直肠癌和息肉
- 批准号:
9221852 - 财政年份:2017
- 资助金额:
$ 76.7万 - 项目类别:
Point of care, real-time urine metabolomics test to diagnose colorectal cancers and polyps in low- and middle-income countries
护理点实时尿液代谢组学测试可诊断低收入和中等收入国家的结直肠癌和息肉
- 批准号:
10378649 - 财政年份:2017
- 资助金额:
$ 76.7万 - 项目类别:
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