Colo-rectal CancerNCT03261752
New Genes in the Carcinogenesis of Colorectal Cancer
An observational study of Colo-rectal Cancer, run by Assiut University.
Trial summary
Colo rectal cancer is one of the greatest ,mutual malignancies worldwide ,accounting for an estimated 1.3 million new cases and >500,000 mortality ⁄ year . is the fourth leading cause of cancer-associated mortality worldwide with speedily ,cumulative ,occurrence rate in the worldwide Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Colo-rectal Cancer
- What is being tested?
- blood sample
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2018to Sep 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 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patient between 35-65 who are newly diagnosed with colorectal cancer
Who may be able to join
- age between 35-65
- patient with colorectal cancer (at any stage)
- both sex included
Who cannot join
- pediatric patients
- patient with insufficient data
- cardiac patient
- pregnant women
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Investigating the Role of SPG20,STK31 Genes in the Carcinogenesis of Colorectal Cancer
Colo rectal cancer is one of the greatest ,mutual malignancies worldwide ,accounting for an estimated 1.3 million new cases and >500,000 mortality ⁄ year . is the fourth leading cause of cancer-associated mortality worldwide with speedily ,cumulative ,occurrence rate in the worldwide
Read the detailed description
colo rectal cancer represents a global and local problem, as it is one of the commonest types of cancer all over the world. Globally, Colo rectal cancer in women (9.2% of diagnoses) it is the second most common cause of cancer . it is the third most common in men (10.0%). After lung, stomach, and liver cancer it is the fourth most common cause of cancer death.
Cancer is a multistep procedure resulting from an ongoing accretion of genetic and epigenetic fluctuations to the genome.
Spartin is a protein that in humans is encoded by the SPG20 gene. This protein may be involved in endosomal trafficking, microtubule dynamics, or both functions. Aberrant promoter methylation of genes is a common epigenetic alteration in colo rectal cancer .
This has stimulated the prospect to implement a dependable, reasonable and simple approach for Colo rectal detection . The SPG20 gene is situated in chromosome band 13q13.3; the SPG20 gene converts the spartin protein, which is a multi functional protein that has formerly been recognized to be complicated in intra cellular epidermal growth factor receptor trading , The serine-threonine kinase 31 (STK31) gene was initially identified through cDNA subtraction as a testis-specific protein kinase gene expressed in mouse spermatogonia . Recently, STK31 has been described as a novel cancer testis (CT) antigen, highly expressed in Gastrointestinal cancer cells (colo rectal, gastric and esophageal cancer), while restricted to testis and fetal brain in normal tissues .
It was found that SPG20 is mutated in Troy er syndrome, an hereditary spastic paraplegia
- Conditions
- Colo-rectal Cancer
- Being tested
- blood sample
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampleDiagnostic test
Total genomic DNA will be extracted DNA extraction kit using a QIAamp DNA Blood Mini kit .Genetic analysis of both SPG20 \&STK31 by RTPCR.
| Study group | Role | What they receive |
|---|---|---|
| patient with cancer | blood sample will be collected from patient before and after treatment (surgery or chemotherapy) Receives: Diagnostic Test: blood sample | |
| healthy people | blood sample will be collected for comparison Receives: Diagnostic Test: blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
detection of SPG20&STK31 genes
detection of SPG20\&STK31 genes and prediction future treatment for colo-rectal cancer
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2017
- Study start1 Oct 2018 (estimated)
- Primary completion1 Sep 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colo-rectal CancerStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariana Anwar, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03261752
- Sponsor's protocol ID
- CRC
- Status last verified
- Jul 2018
- First submitted
- 23 Aug 2017
- Last updated
- 26 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Role of SPG20,STK31 Genes in the Carcinogenesis of Colorectal Cancer
- ClinicalTrials.gov ID
- NCT03261752
- Acronym / sponsor ID
- CRC
- Conditions
- Colo-rectal Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2018 (estimated)
- Primary completion
- 1 Sep 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 25 Aug 2017 (actual)
- 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.
Colo rectal cancer is one of the greatest ,mutual malignancies worldwide ,accounting for an estimated 1.3 million new cases and >500,000 mortality ⁄ year . is the fourth leading cause of cancer-associated mortality worldwide with speedily ,cumulative ,occurrence rate in the worldwide
Detailed description
colo rectal cancer represents a global and local problem, as it is one of the commonest types of cancer all over the world. Globally, Colo rectal cancer in women (9.2% of diagnoses) it is the second most common cause of cancer . it is the third most common in men (10.0%). After lung, stomach, and liver cancer it is the fourth most common cause of cancer death.
Cancer is a multistep procedure resulting from an ongoing accretion of genetic and epigenetic fluctuations to the genome.
Spartin is a protein that in humans is encoded by the SPG20 gene. This protein may be involved in endosomal trafficking, microtubule dynamics, or both functions. Aberrant promoter methylation of genes is a common epigenetic alteration in colo rectal cancer .
This has stimulated the prospect to implement a dependable, reasonable and simple approach for Colo rectal detection . The SPG20 gene is situated in chromosome band 13q13.3; the SPG20 gene converts the spartin protein, which is a multi functional protein that has formerly been recognized to be complicated in intra cellular epidermal growth factor receptor trading , The serine-threonine kinase 31 (STK31) gene was initially identified through cDNA subtraction as a testis-specific protein kinase gene expressed in mouse spermatogonia . Recently, STK31 has been described as a novel cancer testis (CT) antigen, highly expressed in Gastrointestinal cancer cells (colo rectal, gastric and esophageal cancer), while restricted to testis and fetal brain in normal tissues .
It was found that SPG20 is mutated in Troy er syndrome, an hereditary spastic paraplegia
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patient with cancer | – | Diagnostic Test: blood sampleblood sample will be collected from patient before and after treatment (surgery or chemotherapy) |
| healthy people | – | Diagnostic Test: blood sampleblood sample will be collected for comparison |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patient between 35-65 who are newly diagnosed with colorectal cancer
Key inclusion criteria (3 listed)
- age between 35-65
- patient with colorectal cancer (at any stage)
- both sex included
Key exclusion criteria (4 listed)
- pediatric patients
- patient with insufficient data
- cardiac patient
- pregnant women
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 |
|---|---|---|
| blood sampleTotal genomic DNA will be extracted DNA extraction kit using a QIAamp DNA Blood Mini kit .Genetic analysis of both SPG20 \&STK31 by RTPCR. | Diagnostic test | healthy people, patient with cancer |
Primary outcome
detection of SPG20&STK31 genes
Time frame: 5 months
detection of SPG20\&STK31 genes and prediction future treatment for colo-rectal cancer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Colo-rectal Cancer, run by Assiut University.
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 3 inclusion and 4 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 2018. Status can change between updates, so confirm with the study contact before making plans.
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 mariana anwar, M.st (01012944965, mariana.10@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
detection of SPG20&STK31 genes (time frame: 5 months). 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 2018; AzTrials last refreshed its copy on 8 Nov 2026.