Colorectal CancerNCT05520385
Correlation Between Blood Group ,Rh and Obesity With Colorectal Carcinoma
An observational study of Colorectal Cancer, run by Al-Kindy Teaching Hospital.
Trial summary
Aim of study: is there possibility of relationship between ABO blood group, Rh \& obesity with CRC, that is what we tried to show in this study . Read more about this study
- Who is it for?
- Ages 30 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- blood group and Rh
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 1 Feb 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 30 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: those who attending Al-kindy Teaching Hospital for colonoscopic examination
Who may be able to join
- patient with bleeding per rectum
- chronic pain in the right iliac fossa with anemia
- change in bowel habit
- constipation
- tinesmus .
Who cannot join
- Patient with history of other cancer
- those with chronic diseases like H.T, DM ,
- patients presenting with intestinal obstruction due to tumor
- athletics were excluded from the study
About this study
Official title: Correlation Between Blood Group ,Rh and Obesity With Colorectal Carcinoma Among Patients Attending Al-kindy Teaching Hospital/Baghdad
Aim of study: is there possibility of relationship between ABO blood group, Rh \& obesity with CRC, that is what we tried to show in this study .
Read the detailed description
Cancer is an important leading cause of great psychosocial and economic burden worldwide and about 1.23 million individual annually affected by CRC which is considered as the most common type of cancer ( 9.7 % of overall cancers )and 8 % ( 608,000 case ) died with CRC overall cancer death cases , so it's the fourth most common cause of death among different types of cancer .
There is variability in distribution of cases worldwide , as explained by epidemiological data which showed about 60 % of CRC cases presented in developed countries ( 2 % per year ) while in developing countries there is annual increase in the incidence of CRC cases with proportion occurring among patients with age ≤ 40 years is 2 - 8 percent in western countries while in middle east region its about 15 - 35 percent and the incidence rate is less in female than in male with favorable female gender as a prognostic factor over male .
There are three different risk groups for CRC, these are FAP, hereditary nonpolyposis colon cancer syndrome (lynch syndrome), and genetic mutations that lead to sporadic colon cancer .
The exact cause is unclear but many factors are involved including environmental and genetic . About 24 % of the cases with CRC are due to genetic factors while 75 % of the cases are sporadic and 1 % in patients with pre -existing IBD . Those who immigrates to area with high incidence of CRC from low incidence area may prone to develop CRC which may be related to consumption of red meat and decrease physical activity .
The environmental factors including dietary factors like : Lack of fiber , high-fat diet and exposure of mucosa to high levels of bile acids due to impairment of enterohepatic circulation which leading to form carcinogens from degradation of bile salts while previous cholecystectomy has not been proved to be risk for developing CRC .
Regarding genetic factors, there are several genes among them Tumor suppressor genes (e.g. APC, p53 ) , Oncogenes (e.g Ras) and Mismatch-repair genes (e.g hMSH2 and hMLH1) were identified as contributing to hereditary colorectal cancer .
Here in this study two factors will be discussed with their relation to development of CRC , those factors are ABO blood group , Rh factor and the other one is obesity and as following :
Actually , the first human genetic marker are antigens of the ABO system despite of they are a chemical component on erythrocyte membrane but showing expression on variety of epithelial cells including the mucosa of gastrointestinal tract, that was the leading cause observation studies on any correlation between ABO blood group , Rh with tumor .
From first studies, Aird et al in 1953 who reported a correlation between ABO Rh factor and carcinoma of stomach , also recently a significant association with pancreatic tumor had been reported . In addition to many studies showed a relationship between ABO antigen expression and CRC .
Regarding the obesity , about billion of people are now suffering from obesity worldwide which is considered as one of the strongest factors affecting many health conditions among them some cancers \& the prevalence of obesity is rising in many Asian countries including Japan but still lower than western countries .
Many epidemiological studies identified high body mass index as independent risk factor for CRC , some of these studies in western countries showing a significant association between BMI and risk of CRC .
- Conditions
- Colorectal Cancer
- Being tested
- blood group and Rh
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood group and RhDiagnostic test
check of blood group , Rh for patient and control
What is being measured
The primary outcome is the main question the study is designed to answer.
an association between occurrence of CRC and blood group A+ , O + .
Haemagglutination method was used to detect blood group and Rh factor for patients and control group
Measured: baseline
Secondary outcomes (1)
an association between occurrence of CRC and overweight and class І obesity patients
Colonoscopy was done by using Olympus colonoscope , lucera CLV-260 and histopathological examination was done to confirm the diagnosis of CRC
Measured: basline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start1 Jan 2016
- Primary completion1 Jan 2019
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies 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
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Kindy Teaching Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Safaa Hadi Abdulsattar Alshihmani, Al-Kindy Teaching Hospital
- Investigators
- Laith N. Hindoush, doctor, Study chair, Baghdad/Iraq
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05520385
- Sponsor's protocol ID
- colorectal CA
- Status last verified
- Sep 2022
- First submitted
- 20 Aug 2022
- Last updated
- 7 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Blood Group ,Rh and Obesity With Colorectal Carcinoma Among Patients Attending Al-kindy Teaching Hospital/Baghdad
- ClinicalTrials.gov ID
- NCT05520385
- Acronym / sponsor ID
- colorectal CA
- Conditions
- Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Al-Kindy Teaching HospitalUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 29 Aug 2022 (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.
Aim of study: is there possibility of relationship between ABO blood group, Rh \& obesity with CRC, that is what we tried to show in this study .
Detailed description
Cancer is an important leading cause of great psychosocial and economic burden worldwide and about 1.23 million individual annually affected by CRC which is considered as the most common type of cancer ( 9.7 % of overall cancers )and 8 % ( 608,000 case ) died with CRC overall cancer death cases , so it's the fourth most common cause of death among different types of cancer .
There is variability in distribution of cases worldwide , as explained by epidemiological data which showed about 60 % of CRC cases presented in developed countries ( 2 % per year ) while in developing countries there is annual increase in the incidence of CRC cases with proportion occurring among patients with age ≤ 40 years is 2 - 8 percent in western countries while in middle east region its about 15 - 35 percent and the incidence rate is less in female than in male with favorable female gender as a prognostic factor over male .
There are three different risk groups for CRC, these are FAP, hereditary nonpolyposis colon cancer syndrome (lynch syndrome), and genetic mutations that lead to sporadic colon cancer .
The exact cause is unclear but many factors are involved including environmental and genetic . About 24 % of the cases with CRC are due to genetic factors while 75 % of the cases are sporadic and 1 % in patients with pre -existing IBD . Those who immigrates to area with high incidence of CRC from low incidence area may prone to develop CRC which may be related to consumption of red meat and decrease physical activity .
The environmental factors including dietary factors like : Lack of fiber , high-fat diet and exposure of mucosa to high levels of bile acids due to impairment of enterohepatic circulation which leading to form carcinogens from degradation of bile salts while previous cholecystectomy has not been proved to be risk for developing CRC .
Regarding genetic factors, there are several genes among them Tumor suppressor genes (e.g. APC, p53 ) , Oncogenes (e.g Ras) and Mismatch-repair genes (e.g hMSH2 and hMLH1) were identified as contributing to hereditary colorectal cancer .
Here in this study two factors will be discussed with their relation to development of CRC , those factors are ABO blood group , Rh factor and the other one is obesity and as following :
Actually , the first human genetic marker are antigens of the ABO system despite of they are a chemical component on erythrocyte membrane but showing expression on variety of epithelial cells including the mucosa of gastrointestinal tract, that was the leading cause observation studies on any correlation between ABO blood group , Rh with tumor .
From first studies, Aird et al in 1953 who reported a correlation between ABO Rh factor and carcinoma of stomach , also recently a significant association with pancreatic tumor had been reported . In addition to many studies showed a relationship between ABO antigen expression and CRC .
Regarding the obesity , about billion of people are now suffering from obesity worldwide which is considered as one of the strongest factors affecting many health conditions among them some cancers \& the prevalence of obesity is rising in many Asian countries including Japan but still lower than western countries .
Many epidemiological studies identified high body mass index as independent risk factor for CRC , some of these studies in western countries showing a significant association between BMI and risk of CRC .
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- those who attending Al-kindy Teaching Hospital for colonoscopic examination
Key inclusion criteria (5 listed)
- patient with bleeding per rectum
- chronic pain in the right iliac fossa with anemia
- change in bowel habit
- constipation
- tinesmus .
Key exclusion criteria (4 listed)
- Patient with history of other cancer
- those with chronic diseases like H.T, DM ,
- patients presenting with intestinal obstruction due to tumor
- athletics were excluded from the study
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 group and Rhcheck of blood group , Rh for patient and control | Diagnostic test | – |
Primary outcome
an association between occurrence of CRC and blood group A+ , O + .
Time frame: baseline
Haemagglutination method was used to detect blood group and Rh factor for patients and control group
1 secondary outcome
an association between occurrence of CRC and overweight and class І obesity patients
Time frame: basline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2022.
- 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.
Laith N. Hindoush, doctor study chair
Baghdad/Iraq
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by Al-Kindy Teaching Hospital.
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 5 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: finished, as of the sponsor's last update on 7 Sep 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
an association between occurrence of CRC and blood group A+ , O + . (time frame: baseline). 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 7 Sep 2022.