NCT03208777

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 .

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2017

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 3, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 6, 2017

Completed
26 days until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

July 7, 2017

Status Verified

July 1, 2017

Enrollment Period

1 year

First QC Date

July 3, 2017

Last Update Submit

July 5, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • presence of telomeric abnormalities

    measure percentage of telomeric abnormalities in benign and malignant colorectal diseases

    one year

Study Arms (3)

control group

taking blood samples from apparently healthy people

Genetic: taking blood samples

benign colorectal

taking blood samples from patients

Genetic: taking blood samples

malignant colorectal

taking blood samples from patients

Genetic: taking blood samples

Interventions

taking blood samples and measure telomeric abnormalities

benign colorectalcontrol groupmalignant colorectal

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

all patients with colorectal benign or malignant disease

You may qualify if:

  • Adult age group ˃ 18 years.
  • Newly diagnosed cases (no previous treatment).
  • No treatment was taken for HCV infection.

You may not qualify if:

  • age group \< 18 years.
  • Patients with malignancy of other type.
  • Patients not diagnosed by endoscopy or biopsy (not surely diagnosed).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Bosman F, Yan P. Molecular pathology of colorectal cancer. Pol J Pathol. 2014 Dec;65(4):257-66. doi: 10.5114/pjp.2014.48094.

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • fatma magdy zidan, residant

    South Egypt Cancer Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

eman mosaad, prof.dr

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

July 3, 2017

First Posted

July 6, 2017

Study Start

August 1, 2017

Primary Completion

August 1, 2018

Study Completion

August 1, 2019

Last Updated

July 7, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share