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

NCT03002727 | Unknown

• 1 other identifier: 2016/06/17-002
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Cancer Genetics; Young Adult

Keywords

Colorectal cancer; Microsatellite; Colorectal cancer stem cells

Outcome Measures

Primary Outcomes (1)

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

  3 month

Secondary Outcomes (4)

• 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

• 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

• If radiotherapy increases the count of CD +ve 133 cells , does that increase significantly affects the progression free survival

  6 month

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged less than fourty years old with rectosigmoid cancer diagnosed with colonscopic biobsy and received concurrent chemoradiotherapy then went for surgery

You may qualify if:

• 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 .

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Ereny Samwel Poles

Asyut, Egypt

RECRUITING

Related Publications (4)

• 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.

  PMID: 12847364 BACKGROUND

• 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.

  PMID: 14584768 BACKGROUND

• 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.

  PMID: 22219601 BACKGROUND

• 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.

  PMID: 26817916 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Paraffin blocks of colonoscopic biobsy before neoadjuvant concurrent chemoradiotherapy and the blocks of surgery at the end of treatment regemin.

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Ola N Abdl fattah, Ass.Prof

  Assiut University

  STUDY DIRECTOR

• Dalia A El sers, Ass.prof

  Assiut University

  STUDY DIRECTOR

• Mahmoud R Shehata, Lecturer

  Assiut University

  STUDY DIRECTOR

• Samia A Ali, Prof

  Assiut University

  STUDY CHAIR

Central Study Contacts

Ereny S Poles, MsC

CONTACT

01000470421; Rerejesus_dna@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: December 21, 2016
• First Posted: December 26, 2016
• Study Start: December 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: January 1, 2019
• Last Updated: May 8, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)