跳至主要内容
临床试验/NCT03002727
NCT03002727Unknown不适用

Role of CD133 and Microsatellite Status in Evaluation of Young Adults With Rectosigmoid Cancer Received Neoadjuvant Treatment

Assiut University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年12月最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
试验地点
1
主要终点
Differential expression of CD133 based on microsatellite status and correlation with clinicopathological features.

研究概览

简要总结

Microsatellite instability is more common in colorectal cancer ( CRC) young patient which is associated with good prognosis and is considered as a predictor for good response to preoperative chemoradiotherapy. Counting of ( cluster of differentiation) CD 133 +ve cells ,as a marker for enrichment with colorectal cancer stem cells ,is considered as a prognostic marker for poor survival and predictor for radio-resistance. Correlation between microsatellite status ( MS) and CD133 count has not yet studied especially in young patients with rectosigmoid cancer. So the investigators hypothesize that there is correlation between microsatellite status, CD133+ve cells count , occurrence of CRC in young patients and resistance to standard treatment regimen. Improvement of response to treatment and choice of the best regime to avoid non beneficial treatment modality are the goal of this study.

详细描述

The age incidence of colorectal cancer is above fifty years old world wide .But, when comparing the incidence and clinicopathological features of colorectal cancer in western countries and countries with constrained resources as Egypt , there is significant lower median age of incidence. In Egypt reports showed that CRC was detected in 11-15% of patients who underwent colonoscopy and diagnosed in 29-31% of patients aged 40 years or younger . Similar data come from other highly populated resource-constrained countries in Asia . This early onset rectal cancer is mainly poorly differentiated, advanced at prognosis, sporadic with no familial predisposition.Young patients with microsatellite high (MSI-h ) proximal cancer colon are with good prognosis but there is lacking data about the prognostic and predictive role of these genes in young patients with irradiated rectal cancer. As those young aged patients show worse outcome in term of progression free survival and higher rates of metastatic events , we hypothesize that colorectal cancer stem cells (CR-CSC) may have a role in this dismal outcome.CD133 is one of the best-characterized markers of CR-CSCs, many studies have demonstrated that CD133 expression was correlated with survival, recurrence, metastasis and chemotherapy resistance in colorectal cancer.

So the study is trying to establish a correlation between the MS status and enrichment with CR-CSC and if this proposed relationship may have implication of disease outcome and treatment results.

Patients and methods:

The investigators will enroll about 30 patients and will examine the pre- treatment colonoscopic biopsy for

  • Type and grade of carcinoma under light microscopy after staining with haematoxylin and eosin.
  • Immunocytochemistry performed on 4 µ-thick sections from paraffin blocks using the streptavidin-biotin-peroxidase technique. The sections will be routinely deparaffinized, rehydrated through graded alcohols to distilled water. Deparaffinized sections will be treated with 0.3% hydrogen peroxide for 10 min. Suitable antigen retrieval will be carried out. Blocking serum will be applied for 10 min. The sections will be incubated with antibody raised against

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patient less than forty years old with rectosigmoid cancer.
  • Sporadic colorectal cancer patients; no family history of first degree relatives .
  • Diagnosed with colonoscopic biopsy.
  • Patient received neoadjuvant concurrent chemoradiotherapy.
  • Radical surgery was done after neoadjuvant treatment .

排除标准

  • Patient less than 18 and more than forty.
  • Patient who underwent radical surgery from the start for early disease.
  • Patient with metastatic colorectal cancer.
  • patients with positive family history.

结局指标

主要结局

Differential expression of CD133 based on microsatellite status and correlation with clinicopathological features.

时间窗: 3 month

次要结局

  • Define microsatellite status and enrichment with CD + ve 133 as colorectal cancer stem cells as a prognostic marker for this group of patients(6 months)
  • Assess the microsatellite status of young adult with rectosigmoid cancer(3 months)
  • The effect of radiotherapy on the count of CD 133 +ve cells(3 months)
  • If radiotherapy increases the count of CD +ve 133 cells , does that increase significantly affects the progression free survival(6 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ereny Samwel

Assistant lecturer

Assiut University

研究点 (1)

Loading locations...

相似试验