- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03208777
Telomeric Abnormalities in Colorectal Diseases by Fluorescent in Situ Hybridization Technique
Telomeric Abnormalities in Benign and Malignant Colorectal Diseases by Fluorescent in Situ Hybridization Technique
Colorectal carcinoma is a heterogeneous disease that is caused by the interaction of genetic and environmental factors. colorectal carcinoma encompasses a complex disease with different molecular pathways and biological characteristics arising from a multi-step process that implicates several genetic and epigenetic events . The multi-step genetic model involves the loss of function of tumor suppressor genes, such as adenomatous polyposis coli (APC), Telomeres could be a promising marker due to the fact that their lengths change in the colorectal polyp-carcinoma sequence . Moreover, telomere length (TL) is altered in blood cells in patients with colorectal carcinoma
- These findings could suggest that changes in TL may take place before the development of the tumor .
The two main forms of inflammatory bowel disease (IBD), ulcerative colitis (UC) and Crohn's disease (CD) are characterized by chronic intestinal inflammation and risk of progression to colon cancer. One proposed cause of the latter characteristic is chromosome instability, since the rearrangement of genetic material can lead to activation of oncogenes, loss of tumor suppressor genes and other changes that lead to uncontrolled cell growth. Chromosome instability is particularly associated with UC and has been observed in colon epithelial cells and peripheral blood mononuclear cell. Since genomic instability in peripheral blood mononuclear cells (PBMCs) has been used as a biomarker for global cancer risk in a number of diseases, the latter observation suggests the possibility of a chromosome instability syndrome in UC that could affect all tissues. One possible cause of chromosome instability is telomere dysfunction .
Study Overview
Detailed Description
Human chromosomes are capped and stabilized by telomeres, which not only protect them from damage but also have a role in regulating cellular senescence. After reaching a critical length, telomeres experience a double DNA change and cells will eventually enter senescence (replication) or cell death . Telomere length and telomere shortening have been long hypothesized to be a biological marker of aging at the cellular level and a potential mechanism of carcinogenesis. Genomic instability is a critical factor in the initiation and progression of human cancers. One mechanism that underlies genomic instability is loss of telomere function .
fluorescent in situ hybridization is a molecular diagnostic technique that utilizes labeled DNA probes to detect or confirm gene or chromosome abnormalities. fluorescent in situ hybridization is often utilized for both research and diagnosis of hematological malignancies and solid tumors. Conceptually, fluorescent in situ hybridization is a very straightforward technique whereby a DNA probe is hybridized to its complementary sequence on chromosomal preparations previously fixed on microscope slides . fluorescent in situ hybridization is able to detect cells that have chromosomal abnormalities consistent with neoplasia .
There has been a surge of published studies which assessed the association between telomere length and development of colorectal carcinoma. Thus, a meta-analysis addressing colorectal carcinoma and telomere length would be a useful addition to the current information in this area.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult age group ˃ 18 years.
- Newly diagnosed cases (no previous treatment).
- No treatment was taken for HCV infection.
Exclusion Criteria:
- age group < 18 years.
- Patients with malignancy of other type.
- Patients not diagnosed by endoscopy or biopsy (not surely diagnosed).
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
control group
taking blood samples from apparently healthy people
|
taking blood samples and measure telomeric abnormalities
|
|
benign colorectal
taking blood samples from patients
|
taking blood samples and measure telomeric abnormalities
|
|
malignant colorectal
taking blood samples from patients
|
taking blood samples and measure telomeric abnormalities
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
presence of telomeric abnormalities
Time Frame: one year
|
measure percentage of telomeric abnormalities in benign and malignant colorectal diseases
|
one year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: fatma magdy zidan, residant, South Egypt Cancer Institute
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FISH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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