Association Between ABO Polymorphism and Gastric/Colorect... | NCT06149923

Studies
Association Between ABO Polymorphism and Gastric/Colorectal Cancers

NCT06149923

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Nov 29, 2023Actual

Enrollment

184Estimated

Phase

Not provided

Conditions

Gastric Cancer
Colo-rectal Cancer

Interventions

quantitative Real-time PCR

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2023Estimated

Primary Completion Date

Dec 1, 2025Estimated

Completion Date

Jan 1, 2026Estimated

First Submitted Date

Nov 19, 2023

First Submission Date that Met QC Criteria

Nov 27, 2023

First Posted Date

Nov 29, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 27, 2023

Last Update Posted Date

Nov 29, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To assess ABO gene polymorphism (rs8176746) in the patients histopathologically confirmed gastric and/or colorectal cancers relative to healthy controls by real time PCR.

Detailed Description

The ABO blood group system was discovered by the Austrian pathologist Karl Landsteiner in 1901, who classified the blood groups based on the presence of A and B antigens on the surface of red blood cells after noting patterns of agglutination during blood transfusion. Since the discovery of the ABO blood group system , several studies investigating the relationship between the ABO blood group system and various diseases have been conducted , cancer included .

First association between ABO blood group and cancer risk was reported in 1953 in The English patients with gastric cancer.

Gastric cancer is one of the most common malignant tumors of the digestive system , worldwide, gastric cancer is still the fourth most common cancer and the second most common cause of cancer death . The development of gastric cancer is caused by the interaction of genetic and environmental factors , ABO blood grouping is one of the most stable genetic factors.

This association is also observed with other gastrointestinal malignancies, including colorectal cancer which considered the third common cancer in both women and men and responsible for approximately 10% of all cancers, and the third most common cause of cancer related mortality for men and fourth for women .

The ABO is also the first blood group system defined at the gene level . SNP is a single nucleotide polymorphism, is a germ line substitution of a single nucleotide at a specific position in the genome that is present in a sufficiently large fraction of considered population , SNP may act as biological markers, as they can relate to the genes that are associated with various complex diseases as heart diseases, diabetes, cancer … etc.

In previous studies , significant association between ABO gene SNP (rs8176746) , H. Pylori infection, gastric and pancreatic cancer were found , as they observed that this gene SNP was associated with decreased risk of these disorders.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

184Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
cases		Patients that histopathologically confirmed gastric and/or colorectal cancer, males and females.	Genetic: quantitative Real-time PCR

Interventions

Name	Type	Description	Arm Group Labels	Other Names
quantitative Real-time PCR	Genetic	: quantitative real time PCR using 7500 fast real time PCR (Applied Biosystems	cases

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
assess ABO gene polymorphism (rs8176746) in the patients histopathologically confirmed gastric and/colorectal cancers relative to healthy controls.	assess ABO gene polymorphism (rs8176746) in the patients histopathologically confirmed gastric and/colorectal cancers relative to healthy controls by real-time PCR. and determine the impact of ABO phenotype and genotype on risk of development of gastric and/or colorectal cancers.	Baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients that histopathologically confirmed gastric and/or colorectal cancer.
males and females.

Exclusion Criteria:

Presence of other haematological , autoimmune disorders or other malignancies.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients that histopathologically confirmed gastric and/or colorectal cancer, males and females.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Wesam Ashraf Soliman	Contact	01095574120		wesamashraf27@gmail.com

Overall Officials

Not provided

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31969017	Background	Groot HE, Villegas Sierra LE, Said MA, Lipsic E, Karper JC, van der Harst P. Genetically Determined ABO Blood Group and its Associations With Health and Disease. Arterioscler Thromb Vasc Biol. 2020 Mar;40(3):830-838. doi: 10.1161/ATVBAHA.119.313658. Epub 2020 Jan 23.
28031957	Background	Rummel SK, Ellsworth RE. The role of the histoblood ABO group in cancer. Future Sci OA. 2016 Mar 15;2(2):FSO107. doi: 10.4155/fsoa-2015-0012. eCollection 2016 Jun.

ID	Term
D013274	Stomach Neoplasms
D003110	Colonic Neoplasms

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

ID	Term
D016133	Polymerase Chain Reaction
D021141	Nucleic Acid Amplification Techniques
D005821	Genetic Techniques
D008919	Investigative Techniques