NCT05493878

Brief Summary

  1. 1.To study the expression pattern of Integrin alpha 2b (ITGA2b) and Selectin P (SELP) genes of Tumor educated platelets in pancreatic and biliary tree cancer and its diagnostic value.
  2. 2.To investigate correlation between expression levels of ITGA2b and SELP genes and stages of pancreatic and biliary tree cancer.
  3. 3.To investigate correlation between expression levels of ITGA2b, SELP genes, CA 19-9 and CEA in pancreatic and biliary tree cancer patients.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
128

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 9, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

August 9, 2022

Status Verified

August 1, 2022

Enrollment Period

1 year

First QC Date

August 7, 2022

Last Update Submit

August 8, 2022

Conditions

Keywords

ITGA2bSELPTumor educated platelets

Outcome Measures

Primary Outcomes (1)

  • Expression levels of ITGA2b and SELP on Tumor Educated PLatelets for diagnosis of pancreatic and biliary cancer

    To study the expression pattern of ITGA2b and SELP genes of Tumor educated platelets in pancreatic and biliary tree cancer and its diagnostic value.

    Baseline

Secondary Outcomes (1)

  • Correlation between expression levels of ITGA2b and SELP on TEPs and the commonly used tumour marker CEA and CA 19-9 in the diagnosis of pancreatic and biliary cancer.

    Baseline

Interventions

mRNA expressionDIAGNOSTIC_TEST

Tumor educated platelets ITGA2b and SELP mRNA by reverse transcription-quantitative polymerase chain reaction (RT-qPCR).

Also known as: gene expression, ITGA2b, SELP

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study will be conducted at clinical pathology department, Assiut University Hospital, Faculty of medicine, Assiut University. Patient will be recruited from out patient clinics and in patients of the oncology department in Assiut university. Patients diagnosed pathologically as pancreatic and biliary cancer by gold standard test (pancreatic and biliary tract biopsy by endoscopy), male or female at any age

You may qualify if:

  • Patients diagnosed pathologically as pancreatic and biliary cancer by gold standard test (pancreatic and biliary tract biopsy by endoscopy), male or female at any age.

You may not qualify if:

  • History of anti-neoplastic therapy, such as chemotherapy or radiotherapy.
  • Any other types of cancers.
  • Any other clinically systemic acute or chronic inflammatory disease/s within one months.
  • Autoimmune diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Xing S, Zeng T, Xue N, He Y, Lai YZ, Li HL, Huang Q, Chen SL, Liu WL. Development and Validation of Tumor-educated Blood Platelets Integrin Alpha 2b (ITGA2B) RNA for Diagnosis and Prognosis of Non-small-cell Lung Cancer through RNA-seq. Int J Biol Sci. 2019 Jul 24;15(9):1977-1992. doi: 10.7150/ijbs.36284. eCollection 2019.

    PMID: 31523198BACKGROUND
  • D'Ambrosi S, Nilsson RJ, Wurdinger T. Platelets and tumor-associated RNA transfer. Blood. 2021 Jun 10;137(23):3181-3191. doi: 10.1182/blood.2019003978.

    PMID: 33940602BACKGROUND
  • D'Ambrosi S, Visser A, Antunes-Ferreira M, Poutsma A, Giannoukakos S, Sol N, Sabrkhany S, Bahce I, Kuijpers MJE, Oude Egbrink MGA, Griffioen AW, Best MG, Koppers-Lalic D, Oudejans C, Wurdinger T. The Analysis of Platelet-Derived circRNA Repertoire as Potential Diagnostic Biomarker for Non-Small Cell Lung Cancer. Cancers (Basel). 2021 Sep 16;13(18):4644. doi: 10.3390/cancers13184644.

    PMID: 34572871BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gene Expression

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Genetic Phenomena

Study Officials

  • Ola A Afifi, doctor

    Ola A Afifi

    STUDY DIRECTOR
  • Fatma M Helbawi, doctor

    Fatma M Helbawi

    STUDY CHAIR

Central Study Contacts

Amany H Radwan, doctor

CONTACT

Aml A Rayan, doctor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

August 7, 2022

First Posted

August 9, 2022

Study Start

March 1, 2023

Primary Completion

March 1, 2024

Study Completion

May 1, 2024

Last Updated

August 9, 2022

Record last verified: 2022-08