CTRI/2019/01/017219招募中未知
Realtime Enrichment Screen for Outright detection of Latent Undiagnosed malignant Tumors in asymptomatic individuals Efficiently - RESOLUTE
Datar Cancer Genetics Limited0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •Non-cancer arm-
- •For Inclusion, an individual must meet all of the following criteria:
- •1.Age â?? 49 to 75 years for males and 40 to 75 years for females
- •2.Participants with no known diagnosis or past history of cancer
- •3.Willingness to provide blood sample as per study protocol
- •4.Patient should be willing for screening investigations proposed in study protocol.
- •5.Female patient is not pregnant / lactating (self-report)
- •6.Provision of signed informed consent form and expresses understanding of the protocol and its requirements, risks, and discomforts.
- •7.Stated willingness to comply with all study procedures
- •Cancer arm-
- •For Inclusion, an individual must meet all of the following criteria:
- •1.Age â?? 49 to 75 years for males and 40 to 75 years for females
- •2.Able to provide a written informed consent
- •3.Have either of the following:
- •a.Confirmed cancer diagnosis (any stage I-IV) within 90 days prior to study blood draw, based upon assessment of a pathological specimen and are therapy naïve at the time of blood collection
- •b.A high suspicion for a cancer diagnosis by clinical and/or radiological assessment, with planned biopsy or surgical resection to establish a definitive diagnosis within 6 weeks (42 days) after study blood draw and are therapy naïve at the time of blood collection
- •4.Willingness to provide blood sample as per study protocol
- •5.Female patient is not pregnant / lactating (self-report)
- •6.Provision of signed informed consent form and expresses understanding of the protocol and its requirements, risks, and discomforts.
- •7.Stated willingness to comply with all study procedures
- •Benign lesions arm-
- •For Inclusion, an individual must meet all of the following criteria:
- •1.Age â?? 49 to 75 years for males and 40 to 75 years for females
- •2.Able to provide a written informed consent
- •3.Have either of the following:
- •a.Confirmed diagnosis of a benign lump within 90 days prior to study blood draw, based upon assessment of a pathological specimen and are therapy naïve at the time of blood collection
- •b.A high suspicion for a benign lump by clinical and/or radiological assessment, with planned biopsy or surgical resection to establish a definitive diagnosis within 6 weeks (42 days) after study blood draw and are therapy naïve at the time of blood collection
- •4.Willingness to provide blood sample as per study protocol
- •5.Female patient is not pregnant / lactating (self-report)
- •6.Provision of signed informed consent form and expresses understanding of the protocol and its requirements, risks, and discomforts.
- •7.Stated willingness to comply with all study procedures
排除标准
- •Non-cancer arm-
- •For Exclusion, an individual may meet any of the following criteria:
- •1.Known current or prior diagnosis of cancer
- •2.Unable to provide informed consent
- •3.Unable to comply with all project screening procedures
- •4.Current treatment with any investigational drug or intervention
- •5.Pregnant or lactating women (by self-report)
- •6.Age less than 49 or more than 75 years for males and less than 40 or more than 75 years for females
- •7.Unable/unwilling to provide blood sample as per study requirement.
- •8.Oral or IV corticosteroid use in past 14 days prior to blood draw
- •9.Current febrile illness
- •10.Acute exacerbation or flare of an inflammatory condition requiring escalation in medical therapy within 14 days prior to blood draw.
- •11.History of blood transfusion/ PET-CT scan/CT-scan in last 30 days
- •Cancer arm-
- •For Exclusion, an individual may meet any of the following criteria:
- •1.Known prior history of cancer or history of prior or current cancer treatment
- •2.Unable to provide informed consent
- •3.Unable to comply with all project screening procedures
- •4.Current treatment with any investigational drug or intervention
- •5.Pregnant or lactating women (by self-report)
- •6.Age less than 49 or more than 75 years for males and less than 40 or more than 75 years for females
- •7.Unable/unwilling to provide blood sample as per study requirement.
- •8.Oral or IV corticosteroid use in past 14 days prior to blood draw
- •9.Current febrile illness
- •10.Acute exacerbation or flare of an inflammatory condition requiring escalation in medical therapy within 14 days prior to blood draw.
- •11.History of blood transfusion/ PET-CT scan/CT-scan in last 30 days
- •Benign lesions arm-
- •For Exclusion, an individual may meet any of the following criteria:
- •1.Known prior history of cancer or history of prior or current cancer treatment or a high suspicion for a cancer diagnosis
- •2.Unable to provide informed consent
- •3.Unable to comply with all project screening procedures
- •4.Current treatment with any investigational drug or intervention
- •5.Pregnant or lactating women (by self-report)
- •6.Age less than 49 or more than 75 years for males and less than 40 or more than 75 years for females
- •7.Unable/unwilling to provide blood sample as per study requirement.
- •8.Oral or IV corticosteroid use in past 14 days prior to blood draw
- •9.Current febrile illness
- •10.Acute exacerbation or flare of an inflammatory condition requiring escalation in medical therapy within 14 days prior to blood draw.
- •11.History of blood transfusion/ PET-CT scan/CT-scan in last 30 days
研究者
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