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临床试验/CTRI/2023/04/052111
CTRI/2023/04/052111Other不适用

Screening of cancer from peripheral blood sample through different stemcell-based tests

Epigeneres Biotech Pvt Ltd1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2023年8月5日最近更新:

试验速览

阶段
不适用
状态
Other
入组人数
500
试验地点
1
主要终点
Raman Spectroscopy, gene expression patterns of qPCR and rare stem cells

研究概览

简要总结

Aim: Screening of cancer from Peripheral blood sample through different stem cell-based tests

Milestone to be achieved- Collation of data (n=500 subjects including non-cancer individuals and cancer subjects) different phases of study like optimisation and validation.

Objectives:

  1. To assess the feasibility of Raman Spectroscopy as a screening tool for cancer detection

  2. To isolate circulating stem cells from peripheral blood of cancer and non-cancer subjects and determine expression patterns of various markers by quantitative QPCR.

  3. To isolate and enumerate rare/stem cells from peripheral blood of healthy individuals and cancer patients (Flow Cytometry).

  4. To assess the potential of AOB test (Next Generation Sequencing of stem cells/ cancer stem cells/ progenitors enriched from the peripheral blood) for identification of exomic and transcriptomic profile of primary impacted organ.

Exploratory objective:

  1. To identify the cancer subtype and metastatic site using AOB test.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Healthy individuals:
  • 18 years and above healthy individuals will be included in the study.
  • Individuals with no prior history of cancer will be included.
  • Cancer patients:
  • 18 years and above cancer patients will be included in the study.
  • Cancer patients will be confirmed on histopathology irrespective of grade and stage.

排除标准

  • Exclusion criteria:
  • Age less than 18 years.
  • Verified biohazard samples will be excluded.
  • Cancer subjects who have received anticancer treatment within 7 days of sample collection
  • Subjects who have undergone surgery within previous 2 weeks of sample collection
  • Pregnant/ lactating females
  • Subjects who have received growth factors in past 2 weeks.

结局指标

主要结局

Raman Spectroscopy, gene expression patterns of qPCR and rare stem cells

时间窗: Baseline

Identification of cancer and non-cancer subjects using biochemical fingerprints of

时间窗: Baseline

enumeration using Flow cytometry.

时间窗: Baseline

• Identification of primary impacted organ using altered gene expression patterns and

时间窗: Baseline

mutations profile wherever applicable.

时间窗: Baseline

次要结局

未报告次要终点

研究者

申办方类型
Other [Biotechnology Company]

研究点 (1)

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