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Telomeric Abnormalities in Colorectal Diseases by Fluorescent in Situ Hybridization Technique

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ClinicalTrials.gov Identifier: NCT03208777
Recruitment Status : Not yet recruiting
First Posted : July 6, 2017
Last Update Posted : July 7, 2017
Sponsor:
Information provided by (Responsible Party):
fatma magdy zidan, Assiut University

Brief Summary:

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 .


Condition or disease Intervention/treatment
Tumor Gastric Genetic: taking blood samples

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 : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Telomeric Abnormalities in Benign and Malignant Colorectal Diseases by Fluorescent in Situ Hybridization Technique
Estimated Study Start Date : August 1, 2017
Estimated Primary Completion Date : August 1, 2018
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
control group
taking blood samples from apparently healthy people
Genetic: taking blood samples
taking blood samples and measure telomeric abnormalities

benign colorectal
taking blood samples from patients
Genetic: taking blood samples
taking blood samples and measure telomeric abnormalities

malignant colorectal
taking blood samples from patients
Genetic: taking blood samples
taking blood samples and measure telomeric abnormalities




Primary Outcome Measures :
  1. presence of telomeric abnormalities [ Time Frame: one year ]
    measure percentage of telomeric abnormalities in benign and malignant colorectal diseases



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
all patients with colorectal benign or malignant disease
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03208777


Contacts
Contact: eman mosaad, prof.dr 00201065518821 Eman_mosaad@hotmail.com

Sponsors and Collaborators
Assiut University
Investigators
Principal Investigator: fatma magdy zidan, residant South Egypt Cancer Institute

Publications of Results:
Responsible Party: fatma magdy zidan, principle investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03208777     History of Changes
Other Study ID Numbers: FISH
First Posted: July 6, 2017    Key Record Dates
Last Update Posted: July 7, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases