Cancer ColonNCT02542670
Genetic Variants of Selected Genes in Colo-Rectal Cancer Patients.
An observational study of Cancer Colon, run by Sherief Abd-Elsalam at 2 sites in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer Colon
- What is being tested?
- Whole genome sequencing
- How many people
- 50 participants
- Where
- 2 sitesEgypt
- Study dates
- Jul 2015to Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Cancer colon with no distant metastasis Cancer colon with distant metastases control group
Who may be able to join
- Ages Eligible for Study: 10 Years and older
- Genders Eligible for Study: Both
- Patients who can give informed consent themselves
- 10 healthy controls will also be included in the study.
Who cannot join
- Other cancer types rather than CRC.
- Younger age than 10 years
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Sherief Abd-Elsalam
Cairo
Sherief Abd-elsalam, lecturer, 00201000040794, Sherif_tropical@yahoo.com
- Recruiting
Tanta university hospital
Cairo
Sherief Abd-Elsalam, 00201000040794, Sherif_tropical@yahoo.com
About this study
Official title: Genetic Variants of Selected Genes Using Target Deep Sequencing in Colo-Rectal Cancer Patients.
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
Read the 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.
- Conditions
- Cancer Colon
- Being tested
- Whole genome sequencing
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole genome sequencingGenetic
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.
| Study group | Role | What they receive |
|---|---|---|
| Cancer colon with no distant metastasis | Genetic: Whole genome Sequencing Receives: Genetic: Whole genome sequencing | |
| Cancer colon with distant metastases | Genetic: Whole genome Sequencing Receives: Genetic: Whole genome sequencing | |
| control group | Genetic: Whole genome Sequencing Receives: Genetic: Whole genome sequencing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of cancer patients with abnormal genetic mutations .
Number of cancer patients having abnormal genetic mutations .
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2015 (estimated)
- Study startJul 2015
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer ColonStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sherief Abd-Elsalam
- Sponsor type
- University, hospital or other
- Collaborators
- Tanta University
- Responsible party
- Sponsor-investigator, Sherief Abd-Elsalam, Tanta University
- Investigators
- Said Hammad abdou, Prof, Principal investigator, Prof of clincal pathology and geneticsSamah mosaad aboelenein, lecturer, Study director, lecturer of gastroenterology and hepatologyAsem Elfert, Prof, Study chair, Prof of gastroenterology and hepatologySherief Abd-Elsalam, Lecturer, Study chair, lecturer of gastroenterology and hepatologyWalaa Elkhalawany, Lecturer, Study chair, lecturer of gastroenterology and hepatologyNehal Elmashad, Prof, Study chair, Prof of oncologyMohamed Labib Salem, Prof, Study chair, Prof of immunology and geneticsAbdel-Aziz Zidan, lecturer, Study chair, lecturer of immunology and genetics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02542670
- Sponsor's protocol ID
- Dr Said Hammad
- Status last verified
- Jul 2017
- First submitted
- 2 Sep 2015
- Last updated
- 26 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Variants of Selected Genes Using Target Deep Sequencing in Colo-Rectal Cancer Patients.
- ClinicalTrials.gov ID
- NCT02542670
- Acronym / sponsor ID
- Dr Said Hammad
- Conditions
- Cancer Colon
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sherief Abd-ElsalamUniversity, hospital or other
- Collaborators
- Tanta University
- Study start
- Jul 2015 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 7 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cancer colon with no distant metastasis | – | Genetic: Whole genome sequencingGenetic: Whole genome Sequencing |
| Cancer colon with distant metastases | – | Genetic: Whole genome sequencingGenetic: Whole genome Sequencing |
| control group | – | Genetic: Whole genome sequencingGenetic: Whole genome Sequencing |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Cancer colon with no distant metastasis Cancer colon with distant metastases control group
Key inclusion criteria (4 listed)
- Ages Eligible for Study: 10 Years and older
- Genders Eligible for Study: Both
- Patients who can give informed consent themselves
- 10 healthy controls will also be included in the study.
Key exclusion criteria (2 listed)
- Other cancer types rather than CRC.
- Younger age than 10 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole genome sequencingAt 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. | Genetic | Cancer colon with distant metastases, Cancer colon with no distant metastasis, control group |
Primary outcome
Number of cancer patients with abnormal genetic mutations .
Time frame: 2 years
Number of cancer patients having abnormal genetic mutations .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Said Hammad abdou, Prof principal investigator
Prof of clincal pathology and genetics
Samah mosaad aboelenein, lecturer study director
lecturer of gastroenterology and hepatology
Asem Elfert, Prof study chair
Prof of gastroenterology and hepatology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer Colon, run by Sherief Abd-Elsalam at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sherief Abd-Elsalam, Lecturer (00201095159522, sherif_tropical@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of cancer patients with abnormal genetic mutations . (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2017.