CTRI/2021/11/038185招募中未知
Clinical Utility of a Circulating Tumor Cell Detection Test for Detection of Soild Organ Cancers in Asymptomatic Individuals
试验速览
- 阶段
- 未知
- 状态
- 招募中
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
- •1.Adult males and females, aged 30 years and above,
- •2.Provision of Informed Consent ,
- •3.Willing and able to participate in the study and provide blood sample.
- •4.No co-morbidities which could impair study participation or procedures,
- •5.Female participants: neither pregnant, nor lactating
- •6.For Cohort A (Suspected Cases)
- •a.No prior diagnosis .of (any) cancer,
- •b.Presenting with symptoms or radiological I clinical findings suspected of solid
- •organ cancer (priority for localized cancer),
- •c.Biopsy nalve and posted to undergo tissue biopsy for histopathological examination (HPE) as part of standard diagnostic procedure,
- •d.Willing to share HPE findings for the study,
- •e.Optional: Willing for 1-year telephonic follow-up if diagnosed with nonÃ? malignant conditions.
- •7.For Cohort B (Asymptomatic Individuals)
- •a.Baseline risk of cancer,
- •b.Non-smoker ,
- •c.No elevated risk of cancer associated with lifestyle, occupation or any other socioeconomic factors,
- •d.No diagnosis (or sympto ms suggestive) of chronic or new onset diabetes,
- •chronic pulmonary disease or chronic gastrointestinal disease,
- •e.Normal CBC, blood glucose, liver function test and kidney function test,
- •f.No family history of cancer,
- •g.No known genetic predisposition for cancer,
- •h.No prior diagnosis of (any) cancer,
- •i.No prior diagnosis of benign or chronic inflammatory conditions ,
- •j.. No current symptoms or radiological I clinical findings suspected of cancer or
- •benign conditions.
- •k.Optional: Willing for 1-year telephonic follow-up.
排除标准
- •1.Failure to meet general cohort-specific Inclusion Criteria,
- •2.Age less than 30 years ,
- •3.Inability to provide Informed Consent,
- •4.Co-morbidities which could impair study participation or sample collection,
- •5.Current febrile illness,
- •6.Chronic or acute inflammatory conditions within past 14 days,
- •7.Positive for HIV/HBV/HCV,
研究者
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