PDL1- Colorectal CarcinomaNCT05692895
PDL1 In Primary Colorectal Carcinoma and Its Prognostic Impact
An observational study of PDL1- Colorectal Carcinoma, run by Sohag University.
Trial summary
Colorectal cancer (CRC) is a highly heterogenous disease. It the third most commonly diagnosed cancer in the world and the second cause of death among cancer cases mortality. Its incidence is rising all over the world, especially in developing countries . Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- PDL1- Colorectal Carcinoma
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Feb 2023to Jul 2023
- 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A retrospective study will be carried out on 60 colorectal carcinoma specimens that were collected randomly from archives of Pathology Department, Faculty of Medicine, Sohag University
Who may be able to join
- Both endoscopic and excisional biopsy specimens.
- All the studied cases include sufficient materials for the immunohistochemical study.
- Complete clinical data
Who cannot join
- Patients with recurrence of the primary tumor.
- Patients with a history of preoperative chemotherapy and/or radiotherapy.
- Insufficient or tiny tissue biopsies
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Immunohistochemical Expression of PDL1 In Primary Colorectal Carcinoma and Its Prognostic Impact
Colorectal cancer (CRC) is a highly heterogenous disease. It the third most commonly diagnosed cancer in the world and the second cause of death among cancer cases mortality. Its incidence is rising all over the world, especially in developing countries . In Egypt it is coming the seventh cancer in incidence according to World Health Organization (WHO, 2020). Although there is much improvement in the diagnosis and treatment, but CRC is still constituting a big impact on human life and health, so researchers are trying to find out new therapeutic targets .
Programmed cell death protein 1 (PD-1) is an inhibitory receptor which is expressed on the surface of T lymphocytes during activation. Its role is to control T cell effector activity for various cellular responses as infections, autoimmune reactions, and cancer .
Cancer cells develop PD-ligand1 (PD-L1) expression which is a transmembrane molecule belonging to B7 family. Its action is through PD-1/PD-L1 reaction, and causing invasion and metastasis of cancer cells by protecting it from immunosurveillance by inhibiting T cell effector function, leading to carcinogenesis and development of many cancers including colorectal cancer.
- Conditions
- PDL1- Colorectal Carcinoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis and prognosis of colorectal carcinoma
Immunohistochemical expression of PDL1 in primary colorectal carcinoma
Measured: Two or three days after staining tissue sections with PDL1 antibody
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study startFeb 2023 (estimated)
- Primary completionApr 2023 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PDL1- Colorectal CarcinomaStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Ahmed Abdelnaby, Sohag University
- Investigators
- Amira A Abdelnaby, Lecturer, Principal investigator, Faculty of medicine ,Sohag university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05692895
- Sponsor's protocol ID
- Soh-Med-22-12-36
- Status last verified
- Jan 2023
- First submitted
- 11 Jan 2023
- Last updated
- 20 Jan 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 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunohistochemical Expression of PDL1 In Primary Colorectal Carcinoma and Its Prognostic Impact
- ClinicalTrials.gov ID
- NCT05692895
- Acronym / sponsor ID
- Soh-Med-22-12-36
- Conditions
- PDL1- Colorectal Carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Feb 2023 (estimated)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 20 Jan 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.
Colorectal cancer (CRC) is a highly heterogenous disease. It the third most commonly diagnosed cancer in the world and the second cause of death among cancer cases mortality. Its incidence is rising all over the world, especially in developing countries . In Egypt it is coming the seventh cancer in incidence according to World Health Organization (WHO, 2020). Although there is much improvement in the diagnosis and treatment, but CRC is still constituting a big impact on human life and health, so researchers are trying to find out new therapeutic targets .
Programmed cell death protein 1 (PD-1) is an inhibitory receptor which is expressed on the surface of T lymphocytes during activation. Its role is to control T cell effector activity for various cellular responses as infections, autoimmune reactions, and cancer .
Cancer cells develop PD-ligand1 (PD-L1) expression which is a transmembrane molecule belonging to B7 family. Its action is through PD-1/PD-L1 reaction, and causing invasion and metastasis of cancer cells by protecting it from immunosurveillance by inhibiting T cell effector function, leading to carcinogenesis and development of many cancers including colorectal cancer.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A retrospective study will be carried out on 60 colorectal carcinoma specimens that were collected randomly from archives of Pathology Department, Faculty of Medicine, Sohag University
Key inclusion criteria (3 listed)
- Both endoscopic and excisional biopsy specimens.
- All the studied cases include sufficient materials for the immunohistochemical study.
- Complete clinical data
Key exclusion criteria (3 listed)
- Patients with recurrence of the primary tumor.
- Patients with a history of preoperative chemotherapy and/or radiotherapy.
- Insufficient or tiny tissue biopsies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnosis and prognosis of colorectal carcinoma
Time frame: Two or three days after staining tissue sections with PDL1 antibody
Immunohistochemical expression of PDL1 in primary colorectal carcinoma
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2023.
- Individual participant dataSharing planned: Undecided
Related trials for PDL1- Colorectal Carcinoma
Not yet recruitingPhase 2
Intestinal Low-Dose Radiotherapy Combined With Immune Checkpoint Inhibitors in Solid Tumors With Liver Metastases
Liver Metastases, Non-Small Cell Lung Cancer
Active, not recruitingPhase 2
Study of DNA Damage, Angiogenesis, and PD-L1 Inhibitors in Advanced Solid Tumors
Mismatch Repair Proficient Colorectal Cancer, Pancreatic Adenocarcinoma
RecruitingPhase 1/2
The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)
Advanced Solid Tumor, Advanced Malignant Neoplasm
RecruitingObservational study
Research on Effective Strategies After Immunotherapy for Mismatch Repair-deficient Early-stage GI Tumors
Quality of Life (QOL), Mismatch Repair Deficient Colorectal Cancer
Active, not recruitingPhase 2
Radiochemotherapy +/- Durvalumab for Locally-advanced Anal Carcinoma. A Multicenter, Randomized, Phase II Trial of the German Anal Cancer Study Group
Anal Cancer, Anal Carcinoma
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.
Amira A Abdelnaby, Lecturer principal investigator
Faculty of medicine ,Sohag university
Questions about this trial
What is this clinical trial studying?
An observational study of PDL1- Colorectal Carcinoma, 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 3 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 20 Jan 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amira A Abdelnaby, Lecturer (01002097612, ameraabdelnaby55@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis and prognosis of colorectal carcinoma (time frame: Two or three days after staining tissue sections with PDL1 antibody). 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 20 Jan 2023.