Pancreas CancerNCT05493878
ITGA2b and SELP Expression in Cancer Pancreas and Biliary Tract Cancer
An observational study of Pancreas Cancer, run by Assiut University.
Trial summary
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. To investigate correlation between expression levels of ITGA2b and SELP genes and stages of pancreatic and biliary tree cancer. 3. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pancreas Cancer
- What is being tested?
- mRNA expression
- How many people
- 128 participants
- Where
- No sites listed yet
- Study dates
- Mar 2023to May 2024
- How long will I take part?
- 2 Years
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Diagnostic Value of Tumor-Educated Platelets Integrin Alpha 2b (ITGA2B) and Selectin P (SELP) mRNA Expression in Pancreatic and Biliary Tract Cancer
- 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.
- To investigate correlation between expression levels of ITGA2b and SELP genes and stages of pancreatic and biliary tree cancer.
- To investigate correlation between expression levels of ITGA2b, SELP genes, CA 19-9 and CEA in pancreatic and biliary tree cancer patients.
Read the detailed description
Malignant tumors arising in the biliary tract and pancreas are aggressive malignancies characterized by a poor prognosis and most of cases are diagnosed at advanced stages and have poor outcome . The most common pancreatic cancer is ductal adenocarcinoma, which accounts for about 80% of all pancreatic cancers. Pancreatic cancer is a highly lethal gastrointestinal cancer with a low 5-year survival rate and difficulty in early detection . Biliary tract cancers can be divided into intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer. CEA and CA 19-9 are the most common used serum biomarker for cancer screening and the diagnosis of pancreatic and biliary cancer.
Platelets are an essential component of the tumor microenvironment and serve as local and systemic respondents during tumor initiation and tumor metastasis. After interaction with tumor cells or tumor associated biomolecules, platelets can alter their RNA profile, and this process give rise to the so-called tumor educated platelets (TEPs). Tumor cells can directly and indirectly produce changes on platelet RNA and protein content, emerging a new term called liquid biopsy which reflect the presence of cancer and thus give hope to many that they might precede protein markers as a cancer-specific biomarker. Alterations in the TEPs RNA profile have been described as a novel source of potential biomarkers and can be used for early detection of cancer and treatment monitoring. Platelet biomarker transcripts can be transferred from tumor cells to platelets, although in some studies, the putative origin of the biomarker is the megakaryocyte (endogenous).
Integrin Alpha 2b (ITGA2b) gene encodes a member of the integrin alfa chain family of proteins which is proteolytically processed to form subunit of the alpha-IIb/beta-3 integrin cell adhesion receptor which is play crucial role in the blood coagulation system, by mediating platelets aggregation . Selectin P (SELP) gene encodes a protein that is stored in the alpha granules of platelets and Weibel-Palade bodies of endothelial cells. This protein redistributes to the plasma membrane during platelet activation and degranulation and mediates the interaction of activated endothelial cells or platelets with leukocytes. ITGA2b and SELP are cancer related genes and of the mRNA TEPs putative endogenous biomarkers which have a high value for detection of cancer, so, tumor educated platelets (TEPs) broadened the spectrum of liquid biopsy applications, and may enable blood-based cancer diagnostics.
- Conditions
- Pancreas Cancer
- Being tested
- mRNA expression
- Keywords
- ITGA2b, SELP, Tumor educated platelets
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mRNA expressionDiagnostic test
Also called gene expression, ITGA2b, SELP
Tumor educated platelets ITGA2b and SELP mRNA by reverse transcription-quantitative polymerase chain reaction (RT-qPCR).
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
3- To investigate correlation between expression levels of ITGA2b, SELP genes, CA 19-9 and CEA in pancreatic and biliary tree cancer patients.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2022
- Study startMar 2023 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pancreas 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
- Other
- Enrolment
- 128 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amany Hamdy Radwan, Assiut University
- Investigators
- Ola A Afifi, doctor, Study director, Ola A AfifiFatma M Helbawi, doctor, Study chair, Fatma M Helbawi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05493878
- Sponsor's protocol ID
- TEPs genes in cancer pancrease
- Status last verified
- Aug 2022
- First submitted
- 7 Aug 2022
- Last updated
- 9 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31523198D'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.
PubMed 33940602D'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.
PubMed 34572871
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Value of Tumor-Educated Platelets Integrin Alpha 2b (ITGA2B) and Selectin P (SELP) mRNA Expression in Pancreatic and Biliary Tract Cancer
- ClinicalTrials.gov ID
- NCT05493878
- Acronym / sponsor ID
- TEPs genes in cancer pancrease
- Conditions
- Pancreas Cancer
- Keywords
- ITGA2b, SELP, Tumor educated platelets
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Mar 2023 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 9 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.
- 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.
- To investigate correlation between expression levels of ITGA2b and SELP genes and stages of pancreatic and biliary tree cancer.
- To investigate correlation between expression levels of ITGA2b, SELP genes, CA 19-9 and CEA in pancreatic and biliary tree cancer patients.
Detailed description
Malignant tumors arising in the biliary tract and pancreas are aggressive malignancies characterized by a poor prognosis and most of cases are diagnosed at advanced stages and have poor outcome . The most common pancreatic cancer is ductal adenocarcinoma, which accounts for about 80% of all pancreatic cancers. Pancreatic cancer is a highly lethal gastrointestinal cancer with a low 5-year survival rate and difficulty in early detection . Biliary tract cancers can be divided into intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer. CEA and CA 19-9 are the most common used serum biomarker for cancer screening and the diagnosis of pancreatic and biliary cancer.
Platelets are an essential component of the tumor microenvironment and serve as local and systemic respondents during tumor initiation and tumor metastasis. After interaction with tumor cells or tumor associated biomolecules, platelets can alter their RNA profile, and this process give rise to the so-called tumor educated platelets (TEPs). Tumor cells can directly and indirectly produce changes on platelet RNA and protein content, emerging a new term called liquid biopsy which reflect the presence of cancer and thus give hope to many that they might precede protein markers as a cancer-specific biomarker. Alterations in the TEPs RNA profile have been described as a novel source of potential biomarkers and can be used for early detection of cancer and treatment monitoring. Platelet biomarker transcripts can be transferred from tumor cells to platelets, although in some studies, the putative origin of the biomarker is the megakaryocyte (endogenous).
Integrin Alpha 2b (ITGA2b) gene encodes a member of the integrin alfa chain family of proteins which is proteolytically processed to form subunit of the alpha-IIb/beta-3 integrin cell adhesion receptor which is play crucial role in the blood coagulation system, by mediating platelets aggregation . Selectin P (SELP) gene encodes a protein that is stored in the alpha granules of platelets and Weibel-Palade bodies of endothelial cells. This protein redistributes to the plasma membrane during platelet activation and degranulation and mediates the interaction of activated endothelial cells or platelets with leukocytes. ITGA2b and SELP are cancer related genes and of the mRNA TEPs putative endogenous biomarkers which have a high value for detection of cancer, so, tumor educated platelets (TEPs) broadened the spectrum of liquid biopsy applications, and may enable blood-based cancer diagnostics.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 2 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| mRNA expressionAlso: gene expression, ITGA2b, SELPTumor educated platelets ITGA2b and SELP mRNA by reverse transcription-quantitative polymerase chain reaction (RT-qPCR). | Diagnostic test | – |
Primary outcome
Expression levels of ITGA2b and SELP on Tumor Educated PLatelets for diagnosis of pancreatic and biliary cancer
Time frame: Baseline
To study the expression pattern of ITGA2b and SELP genes of Tumor educated platelets in pancreatic and biliary tree cancer and its diagnostic value.
1 secondary outcome
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.
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2022.
- Background: PubMed 31523198Xing 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.
- Background: PubMed 33940602D'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.
- Background: PubMed 34572871D'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.
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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.
Ola A Afifi, doctor study director
Ola A Afifi
Fatma M Helbawi, doctor study chair
Fatma M Helbawi
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreas 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 1 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 9 Aug 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amany H Radwan, doctor (00201116859359, amany.hamdy91@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expression levels of ITGA2b and SELP on Tumor Educated PLatelets for diagnosis of pancreatic and biliary cancer (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05493878, which also lists 3 linked publications.
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 9 Aug 2022.