Pancreatic AdenocarcinomaNCT06055647
HER-2 Expression in Pancreatic Duct Adenocarcinoma
An observational study of Pancreatic Adenocarcinoma, run by Sohag University.
Trial summary
Pancreatic duct adenocarcinoma is a highly aggressive carcinoma that is associated with a poor prognosis. Detection of novel biological markers that are specifically over expressed in pancreatic duct adenocarcinoma and their subsequent targeting by anti cancer therapeutic modalities may improve patient's survival. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pancreatic Adenocarcinoma
- What is being tested?
- immunohistochemical approach
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 31 Dec 2020
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: • This study will be performed on archived formalin-fixed, paraffin-embedded tissue blocks that belonged to 37 patients who were admitted to Assuit and Sohag Oncology Centers and Sohag university hospital from January, 1st, 2017 to December, 31st, 2020. Patients' complaints included obstructive jaundice, abdominal pain and vomiting. Radiological assessment revealed heterogeneous suspicious pancreatic lesions from which tru-cut biopsies were obtained and examined by the standard staining method; hematoxylin and eosin (H\&E). Cases diagnosed as pancreatic carcinoma on the basis of tru-cut biopsies underwent pancreaticoduodenectomy (Whipple procedure) or distal pancreatectomy, depending on tumor location.
Who may be able to join
- Cases of PDAC who underwent radical operations.
- Tissue blocks with sufficient material.
- Cases with available clinical data.
Who cannot join
- Cases of pancreatic carcinoma other than PDAC.
- Patients who received preoperative chemotherapy or radiotherapy.
- Patients with PDAC who were diagnosed by tru-cut biopsies only and didn't undergo radical operations.
- Cases with insufficient/destructed material.
- Patients with inadequate clinical data.
About this study
Official title: Evaluation of Immunohistochemical Expression of Human Epidermal Growth Factor Receptor 2 (HER 2) and Its Association With Clinicopathological Variables in Patients With Pancreatic Duct Adenocarcinoma in Upper Egypt
Pancreatic duct adenocarcinoma is a highly aggressive carcinoma that is associated with a poor prognosis. Detection of novel biological markers that are specifically over expressed in pancreatic duct adenocarcinoma and their subsequent targeting by anti cancer therapeutic modalities may improve patient's survival.
Read the detailed description
Pancreatic duct adenocarcinoma (PDAC) is a deadly neoplasm that showed current increase in its occurrence. There are many challenges in PDAC; the tumor is frequently associated with perineural invasion and angioinvasion, these lead to early metastasis.Another important challenge is that the tumor is associated with extensive fibrosis that prevents arrival of chemotherapeutic agents. Most modern anti-cancer therapeutic modalities depend on the biologic signature of the tumor. Human epidermal growth factor receptor-2 (HER-2) is a cell surface protein that is associated with enhanced cellular proliferation. HER-2 has been detected and successfully targeted in many human carcinomas as breast and gastric cancers. we aimed to evaluate the potential cancer-promoting effect of HER-2 in PDAC, in order to detect any possible benefits of its targeting by future therapeutic modalities.
- Conditions
- Pancreatic Adenocarcinoma
- Being tested
- immunohistochemical approach
- Keywords
- HER-2, Pancreatic Duct Adenocarcinoma, Immunohistochemistry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immunohistochemical approachGenetic
Formalin-fixed, Paraffin-embedded tissue blocks of pancreatic duct adenocarcinoma will be stained by anti HER-2, by immunohistochemical approach.
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation of HRE-2 expression with clinical and pathological parameters
levels of HER-2 expression will be correlated with clinical parameters (as patients' ages, sexes, tumor location), and pathological parameters (as tumor grades, stages, neural and vascular invasion).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start1 Jan 2017
- Primary completion31 Aug 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Sohag 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 only
- Time perspective
- Retrospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maisa Hashem Mohammed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06055647
- Sponsor's protocol ID
- Soh-Med-23-09-4PD
- Status last verified
- Sep 2023
- First submitted
- 20 Sep 2023
- Last updated
- 28 Sep 2023
- 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 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Immunohistochemical Expression of Human Epidermal Growth Factor Receptor 2 (HER 2) and Its Association With Clinicopathological Variables in Patients With Pancreatic Duct Adenocarcinoma in Upper Egypt
- ClinicalTrials.gov ID
- NCT06055647
- Acronym / sponsor ID
- Soh-Med-23-09-4PD
- Conditions
- Pancreatic Adenocarcinoma
- Keywords
- HER-2, Pancreatic Duct Adenocarcinoma, Immunohistochemistry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 28 Sep 2023 (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.
Pancreatic duct adenocarcinoma is a highly aggressive carcinoma that is associated with a poor prognosis. Detection of novel biological markers that are specifically over expressed in pancreatic duct adenocarcinoma and their subsequent targeting by anti cancer therapeutic modalities may improve patient's survival.
Detailed description
Pancreatic duct adenocarcinoma (PDAC) is a deadly neoplasm that showed current increase in its occurrence. There are many challenges in PDAC; the tumor is frequently associated with perineural invasion and angioinvasion, these lead to early metastasis.Another important challenge is that the tumor is associated with extensive fibrosis that prevents arrival of chemotherapeutic agents. Most modern anti-cancer therapeutic modalities depend on the biologic signature of the tumor. Human epidermal growth factor receptor-2 (HER-2) is a cell surface protein that is associated with enhanced cellular proliferation. HER-2 has been detected and successfully targeted in many human carcinomas as breast and gastric cancers. we aimed to evaluate the potential cancer-promoting effect of HER-2 in PDAC, in order to detect any possible benefits of its targeting by future therapeutic modalities.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- • This study will be performed on archived formalin-fixed, paraffin-embedded tissue blocks that belonged to 37 patients who were admitted to Assuit and Sohag Oncology Centers and Sohag university hospital from January, 1st, 2017 to December, 31st, 2020. Patients' complaints included obstructive jaundice, abdominal pain and vomiting. Radiological assessment revealed heterogeneous suspicious pancreatic lesions from which tru-cut biopsies were obtained and examined by the standard staining method; hematoxylin and eosin (H\&E). Cases diagnosed as pancreatic carcinoma on the basis of tru-cut biopsies underwent pancreaticoduodenectomy (Whipple procedure) or distal pancreatectomy, depending on tumor location.
Key inclusion criteria (3 listed)
- Cases of PDAC who underwent radical operations.
- Tissue blocks with sufficient material.
- Cases with available clinical data.
Key exclusion criteria (5 listed)
- Cases of pancreatic carcinoma other than PDAC.
- Patients who received preoperative chemotherapy or radiotherapy.
- Patients with PDAC who were diagnosed by tru-cut biopsies only and didn't undergo radical operations.
- Cases with insufficient/destructed material.
- Patients with inadequate clinical data.
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 |
|---|---|---|
| immunohistochemical approachFormalin-fixed, Paraffin-embedded tissue blocks of pancreatic duct adenocarcinoma will be stained by anti HER-2, by immunohistochemical approach. | Genetic | – |
Primary outcome
correlation of HRE-2 expression with clinical and pathological parameters
Time frame: 6 months
levels of HER-2 expression will be correlated with clinical parameters (as patients' ages, sexes, tumor location), and pathological parameters (as tumor grades, stages, neural and vascular invasion).
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 28 Sep 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Adenocarcinoma, run by Sohag 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 5 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 28 Sep 2023. 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?
correlation of HRE-2 expression with clinical and pathological parameters (time frame: 6 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 28 Sep 2023.