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Genetic Variants of Selected Genes in Colo-Rectal Cancer Patients.

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ClinicalTrials.gov Identifier: NCT02542670
Recruitment Status : Unknown
Verified July 2017 by Sherief Abd-Elsalam, Tanta University.
Recruitment status was:  Recruiting
First Posted : September 7, 2015
Last Update Posted : July 26, 2017
Sponsor:
Collaborator:
Tanta University
Information provided by (Responsible Party):
Sherief Abd-Elsalam, Tanta University

Brief Summary:
Colorectal cancers (CRC) are the third most common human malignancy, and are also the leading cause of cancer related deaths worldwide. Early detection of premalignant lesions such as adenomatous polyps has decreased the risk of CRCs; however, cases which are initially undetected and progress to advanced CRC with distant metastasis are still unfortunately incurable. The development of CRC is a complex and heterogeneous process arising from an interaction between multiple etiological factors, including genetic factors and environmental factors such as diet and lifestyle. The challenges are to understand the molecular basis of individual susceptibility to colorectal cancer and to determine factors that initiate the development of the tumor, drive its progression, and determine its responsiveness or resistance to antitumor agents. Next generation sequencing(NGS)-driven genomic studies are already reporting novel features of cancer genomes beyond the traditional mutational categories. Recent advance in sequencing technology has enabled comprehensive profiling of genetic alterations in CRC.These methods are facilitating an increase in the efficiency and resolution of detection of each of the principal types of somatic cancer genome alterations, including nucleotide substitutions, small insertions and deletions, copy number alterations, chromosomal rearrangements,DNA methylation sequencing such as bisulfite-sequencing and microbial infections. Besides the microsatellite instability (MSI), some researchers reported novel mitochondrial mutations in the cancer genomes. NGS technology will help the investigators for understanding of entire CRC genomes and the obtained knowledge will lead to a better diagnosis and personalized targeted therapeutics for CRC management

Condition or disease Intervention/treatment
Cancer Colon Genetic: Whole genome sequencing

Detailed Description:
Identification of the problem:Colorectal cancers (CRC) are the third most common human malignancy, and are also the leading cause of cancer related deaths worldwide. Early detection of premalignant lesions such as adenomatous polyps has decreased the risk of CRCs; however, cases which are initially undetected and progress to advanced CRC with distant metastasis are still unfortunately incurable. The development of CRC is a complex and heterogeneous process arising from an interaction between multiple etiological factors, including genetic factors and environmental factors such as diet and lifestyle. The challenges are to understand the molecular basis of individual susceptibility to colorectal cancer and to determine factors that initiate the development of the tumor, drive its progression, and determine its responsiveness or resistance to antitumor agents. Next generation sequencing(NGS)-driven genomic studies are already reporting novel features of cancer genomes beyond the traditional mutational categories. Recent advance in sequencing technology has enabled comprehensive profiling of genetic alterations in CRC.These methods are facilitating an increase in the efficiency and resolution of detection of each of the principal types of somatic cancer genome alterations, including nucleotide substitutions, small insertions and deletions, copy number alterations, chromosomal rearrangements,DNA methylation sequencing such as bisulfite-sequencing and microbial infections. Besides the microsatellite instability (MSI), some researchers reported novel mitochondrial mutations in the cancer genomes.NGS technology will help the investigators for understanding of entire CRC genomes and the obtained knowledge will lead to a better diagnosis and personalized targeted therapeutics for CRC management.Experimental design: The study design to attempt to identify the unique mutational spectrum and novel targets of genomic, epigenetic alterations in Egyptian colorectal cancer patients in Delta Regionusing Whole Exome and Epigenetic deep sequencing.Expected results:NGS-based genome analysis facilitates the identification of unrecognized gene mutation of Egyptian CRC cancer especially in Delta Region which may be biologically different from Western CRC as the environmental factors are different.Significance of the expected results:The results of this project will benefit in(1) Identification of novel features or mutation types in CRC genomes In Delta Region. (2) Understanding the advancement of pathway-level in colorectal carcinogenesis and (3) Identify Clinically relevant genetic and epigenetic biomarkers for noninvasive diagnosis and clinically actionable targets for personalized targeted medicine.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Genetic Variants of Selected Genes Using Target Deep Sequencing in Colo-Rectal Cancer Patients.
Actual Study Start Date : July 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Cancer colon with no distant metastasis
Genetic: Whole genome Sequencing
Genetic: Whole genome sequencing
At least 50 ng of tumor DNA will be extracted from FFPE samples and/or fresh tissue and used for hybridization capture and NGS using the IlluminaMiSeqDx platform.

Cancer colon with distant metastases
Genetic: Whole genome Sequencing
Genetic: Whole genome sequencing
At least 50 ng of tumor DNA will be extracted from FFPE samples and/or fresh tissue and used for hybridization capture and NGS using the IlluminaMiSeqDx platform.

control group
Genetic: Whole genome Sequencing
Genetic: Whole genome sequencing
At least 50 ng of tumor DNA will be extracted from FFPE samples and/or fresh tissue and used for hybridization capture and NGS using the IlluminaMiSeqDx platform.




Primary Outcome Measures :
  1. Number of cancer patients with abnormal genetic mutations . [ Time Frame: 2 years ]
    Number of cancer patients having abnormal genetic mutations .


Biospecimen Retention:   Samples With DNA
At least 50 ng of tumor DNA will be extracted from FFPE samples and/or fresh tissue and used for hybridization capture and NGS using the IlluminaMiSeqDx platform.


Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Cancer colon with no distant metastasis Cancer colon with distant metastases control group
Criteria

Inclusion Criteria:

  1. Ages Eligible for Study: 10 Years and older
  2. Genders Eligible for Study: Both
  3. Patients who can give informed consent themselves
  4. 10 healthy controls will also be included in the study.

Exclusion Criteria:

  1. Other cancer types rather than CRC.
  2. Younger age than 10 years

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): NCT02542670


Contacts
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Contact: Sherief Abd-Elsalam, Lecturer 00201095159522 sherif_tropical@yahoo.com

Locations
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Egypt
Sherief Abd-Elsalam Recruiting
Cairo, Egypt
Contact: Sherief Abd-elsalam, lecturer    00201000040794    Sherif_tropical@yahoo.com   
Tanta university hospital Recruiting
Cairo, Egypt
Contact: Sherief Abd-Elsalam    00201000040794    Sherif_tropical@yahoo.com   
Sponsors and Collaborators
Sherief Abd-Elsalam
Tanta University
Investigators
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Principal Investigator: Said Hammad abdou, Prof Prof of clincal pathology and genetics
Study Director: Samah mosaad aboelenein, lecturer lecturer of gastroenterology and hepatology
Study Chair: Asem Elfert, Prof Prof of gastroenterology and hepatology
Study Chair: Sherief Abd-Elsalam, Lecturer lecturer of gastroenterology and hepatology
Study Chair: Walaa Elkhalawany, Lecturer lecturer of gastroenterology and hepatology
Study Chair: Nehal Elmashad, Prof Prof of oncology
Study Chair: Mohamed Labib Salem, Prof Prof of immunology and genetics
Study Chair: Abdel-Aziz Zidan, lecturer lecturer of immunology and genetics
Study Chair: Amira youssef, lecturer Lecturer of clinical pathology
Study Chair: Ayman Elsaka, prof Prof of pathology
Study Chair: Gamal Mousa, prof Prof of general surgery
Study Chair: Khalil Abas, Prof Prof of public health and medical statistics
Study Chair: Osama Elkhadrawy, Prof Prof of general surgery
Study Chair: Eman Ebrahim Ebrahim Farghal, Ph.D. Tanta University
Study Chair: Marwa H Saied, Ph.D. Tanta University
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Responsible Party: Sherief Abd-Elsalam, Lecturer, Tanta University
ClinicalTrials.gov Identifier: NCT02542670    
Other Study ID Numbers: Dr Said Hammad
First Posted: September 7, 2015    Key Record Dates
Last Update Posted: July 26, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases