AzTrials
AzTrials

Colorectal Cancer GeneticsNCT03002727

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

An observational study of Colorectal Cancer Genetics and Young Adult, run by Assiut University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 40 years
Conditions the study is for
Colorectal Cancer Genetics, Young Adult
How many people
30 participants
Where
1 siteEgypt
Study dates
Dec 2016to Jan 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • No healthy volunteers
  • Adult

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

Who may be able to join

  • 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 .

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Ereny S Poles, MsC contact

01000470421 ext. +2

Rerejesus_dna@yahoo.com

Egypt1 site, 1 recruiting

  • Ereny Samwel Poles

    Asyut

    Ereny S Poles, MsC, 01000470421 ext. +2, rerejesus_dna@yahoo.com

    Ola N Abdl fatah, Ass.prof

    Recruiting

Other trials in Egypt

About this study

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

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.

Read the detailed description

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
  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 <!-- -->
  3. 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.
  4. 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
Keywords
Colorectal cancer, Microsatellite, Colorectal cancer stem cells
Medical subject headings
Colorectal Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 3 month

Secondary outcomes (4)

  1. Assess the microsatellite status of young adult with rectosigmoid cancer

    Define the microsatellite status of this group of patient as it is underrepresented in the most of studies

    Measured: 3 months

  2. The effect of radiotherapy on the count of CD 133 +ve cells

    Examine if radiotherapy increases the stemness of the tumour

    Measured: 3 months

  3. Define microsatellite status and enrichment with CD + ve 133 as colorectal cancer stem cells as a prognostic marker for this group of patients

    Measured: 6 months

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

    Measured: 6 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Dec 2016 (estimated)
  2. Study startDec 2016
  3. Primary completionDec 2018 (estimated)
  4. Study completionJan 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03002727
Sponsor's protocol ID
2016/06/17-002
Status last verified
May 2018
First submitted
21 Dec 2016
Last updated
8 May 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 12847364

  • 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.

    PubMed 14584768

  • 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.

    PubMed 22219601

  • 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.

    PubMed 26817916

Questions about this trial

What is this clinical trial studying?

An observational study of Colorectal Cancer Genetics and Young Adult, run by Assiut University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ereny S Poles, MsC (01000470421 ext. +2, Rerejesus_dna@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Differential expression of CD133 based on microsatellite status and correlation with clinicopathological features. (time frame: 3 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03002727, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in