Role of CD133 & Microsatellite Status in Evaluation of Rectosigmoid Cancer Young Adults Received Neoadjuvant Treatment
NCT ID: NCT03002727
Last Updated: 2018-05-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
30 participants
OBSERVATIONAL
2016-12-31
2019-01-31
Brief Summary
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Detailed Description
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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 ยต-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
1. MMR proteins : MLH1, MSH2, or MSH6,PMS-2 .
2. CD133. Then the investigators will collect the blocks from the same patients after receiving neoadjuvant chemoradiotherapy and underwent surgery and examine
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1. Under light microscope after staining for :Type and grade of carcinoma Angiovascular invasion Degree of immune response Pattern and depth of invasion Lymph node status.
2. CD 133 positive cell count with the same previously reported technique . The resulting immune complex will be detected by a universal staining kit following the instructions attached with the kit. Slides will be washed several times in phosphate buffer saline and will be placed in it for 5 minutes between each step except after peroxidase reagent the washing will be by distilled water. Negative and positive controls will be included in each staining series. Immunohistochemical evaluation will be done according to Ren F et al and Zhang X et al . Digital images will be obtained with a digital camera system
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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 .
Exclusion Criteria
* Patient who underwent radical surgery from the start for early disease.
* Patient with metastatic colorectal cancer.
* patients with positive family history.
18 Years
40 Years
ALL
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Ereny Samwel
Assistant lecturer
Principal Investigators
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Ola N Abdl fattah, Ass.Prof
Role: STUDY_DIRECTOR
Assiut University
Dalia A El sers, Ass.prof
Role: STUDY_DIRECTOR
Assiut University
Mahmoud R Shehata, Lecturer
Role: STUDY_DIRECTOR
Assiut University
Samia A Ali, Prof
Role: STUDY_CHAIR
Assiut University
Locations
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Ereny Samwel Poles
Asyut, , Egypt
Countries
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Central Contacts
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Facility Contacts
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References
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Chiang JM, Chen MC, Changchien CR, Chen JS, Tang R, Wang JY, Yeh CY, Fan CW, Tsai WS. Favorable influence of age on tumor characteristics of sporadic colorectal adenocarcinoma: patients 30 years of age or younger may be a distinct patient group. Dis Colon Rectum. 2003 Jul;46(7):904-10. doi: 10.1007/s10350-004-6683-1.
El-Hennawy MM, Moussa ME, El-Saeidy MK, Shawky AM, Bessa SS, Badour NM. Rectal carcinoma in Egyptian patients less than 40 years of age. Int Surg. 2003 Jul-Sep;88(3):137-44.
Park CH, Kim HC, Cho YB, Yun SH, Lee WY, Park YS, Choi DH, Chun HK. Predicting tumor response after preoperative chemoradiation using clinical parameters in rectal cancer. World J Gastroenterol. 2011 Dec 28;17(48):5310-6. doi: 10.3748/wjg.v17.i48.5310.
Huh JW, Kim HC, Kim SH, Park YA, Cho YB, Yun SH, Lee WY, Park HC, Choi DH, Park JO, Park YS, Chun HK. Mismatch Repair Gene Expression as a Predictor of Tumor Responses in Patients With Rectal Cancer Treated With Preoperative Chemoradiation. Medicine (Baltimore). 2016 Jan;95(3):e2582. doi: 10.1097/MD.0000000000002582.
Other Identifiers
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2016/06/17-002
Identifier Type: -
Identifier Source: org_study_id
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