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

NCT02542670 | Unknown DMC

• 1 other identifier: Dr Said Hammad
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

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

Conditions

Cancer Colon

Outcome Measures

Primary Outcomes (1)

• Number of cancer patients with abnormal genetic mutations .

  Number of cancer patients having abnormal genetic mutations .

  2 years

Study Arms (3)

Cancer colon with no distant metastasis

Genetic: Whole genome Sequencing

Genetic: Whole genome sequencing

Cancer colon with distant metastases

Genetic: Whole genome Sequencing

Genetic: Whole genome sequencing

control group

Genetic: Whole genome Sequencing

Genetic: Whole genome sequencing

Interventions

Whole genome sequencing GENETIC

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; Cancer colon with no distant metastasis; control group

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cancer colon with no distant metastasis Cancer colon with distant metastases control group

You may qualify if:

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

You may not qualify if:

• Other cancer types rather than CRC.
• Younger age than 10 years

Sponsors & Collaborators

• Sherief Abd-Elsalam: lead
• Tanta University: collaborator

Study Sites (2)

Sherief Abd-Elsalam

Cairo, Egypt

RECRUITING

Tanta university hospital

Cairo, Egypt

RECRUITING

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.

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Whole Genome Sequencing

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Sequence Analysis, DNA; Sequence Analysis; Genetic Techniques; Investigative Techniques

Study Officials

• Said Hammad abdou, Prof

  Prof of clincal pathology and genetics

  PRINCIPAL INVESTIGATOR

• Samah mosaad aboelenein, lecturer

  lecturer of gastroenterology and hepatology

  STUDY DIRECTOR

• 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

  STUDY CHAIR

Central Study Contacts

Sherief Abd-Elsalam, Lecturer

CONTACT

00201095159522; sherif_tropical@yahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: September 2, 2015
• First Posted: September 7, 2015
• Study Start: July 1, 2015
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: July 26, 2017

Record last verified: 2017-07

Locations

EG (2)