Colorectal CarcinomaNCT07047482
Clinicopathological Value of p16 Expression in Colorectal Carcinoma
An observational study of Colorectal Carcinoma, run by Sohag University at 1 site in Egypt.
Trial summary
Evaluation of the immunohistochemical expression of p16 in colorectal carcinoma and correlate its expression to different clinical and pathological parameters as patients' ages, sexes, tumor location, histopathological phenotype, status of nodal involvement, perineural and lymphovascular invasion. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colorectal Carcinoma
- What is being tested?
- Immunohistochemical staining
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2025to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Fifty (50) cases of colorectal cancer will be performed from archieved formalin-fixed, paraffin-embedded tissue blocks referred to Pathology Department, Sohag University Hospitals.
Who may be able to join
- Specimens from patients with colorectal cancer.
- Tissue blocks with sufficient material.
- Specimens with sufficient clinical data.
Who cannot join
- Tissue blocks with insufficient, destroyed or necrotic material.
- Specimens with insufficient clinical data.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sherry R Azmy, Demonstrator of pathology contact
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine
Sohag, Recruiting
Magdy M Amin, Professor
Sherry R Azmy, Demonstrator of pathology, 01507557371 ext. 01507557371, shery.raoof@med.sohag.edu.eg
About this study
Official title: Clinicopathological Value of p16 Expression in Colorectal Carcinoma: An Immunohistochemical Study.
Evaluation of the immunohistochemical expression of p16 in colorectal carcinoma and correlate its expression to different clinical and pathological parameters as patients' ages, sexes, tumor location, histopathological phenotype, status of nodal involvement, perineural and lymphovascular invasion.
Read the detailed description
Colorectal Carcinoma is very common nowadays, with increasing need for further research.
p16 is tumor suppressor gene with a vital rule ; inactivation of p16 leads to tumor formation and progression.
50 Specimens will be collected from Pathology Department of Sohag University Hospital. Sufficient clinical and histopathological data will be attached for each case.
The previously processed formalin-fixed, paraffin-embedded tissue blocks will be used to get Hematoxylin \& Eosin stained sections to confirm the diagnosis and to detect the histopathological type, grade and stage of each tumor.
Another sliced tissue sections will be immunohistochemically stained with p16 monoclonal antibodies to be evaluated with the positivity, intensity and distribution of the detected stain.
- Conditions
- Colorectal Carcinoma
- Being tested
- Immunohistochemical staining
- Keywords
- p16 Expression, Colorectal Carcinoma, Immunohistochemical study
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunohistochemical stainingBiological
Immunohistochemical staining of paraffin embedded blocks of colorectal carcinoma tissues by p16 monoclonal antibodies to be evaluated with the positivity, intensity and distribution of the detected stain.
| Study group | Role | What they receive |
|---|---|---|
| Participants | Fifty (50) cases of colorectal cancer will be performed from archieved formalin-fixed, paraffin-embedded tissue blocks referred to Pathology Department, Sohag University Hospitals. Receives: Biological: Immunohistochemical staining |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of p16 Expression in Colorectal Carcinoma.
Immunohistochemical staining of Colorectal tissues by p16 monoclonal antibody
Measured: 6 months
Secondary outcomes (1)
Correlation of p16 expression to different clinical and pathological parameters
Correlation of p16 expression to different clinical and pathological parameters as patients' ages, sexes, tumor location, histopathological phenotype, status of nodal involvement, perineural and lymphovascular 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 posted2 Jul 2025
- Study start1 May 2025
- Primary completion21 Mar 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherry Raouf Azmy, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07047482
- Sponsor's protocol ID
- Soh-Med--25-6-2MS
- Status last verified
- Jul 2025
- First submitted
- 24 Jun 2025
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Not decided yet
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinicopathological Value of p16 Expression in Colorectal Carcinoma: An Immunohistochemical Study.
- ClinicalTrials.gov ID
- NCT07047482
- Acronym / sponsor ID
- Soh-Med--25-6-2MS
- Conditions
- Colorectal Carcinoma
- Keywords
- p16 Expression, Colorectal Carcinoma, Immunohistochemical study
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 21 Mar 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 2 Jul 2025 (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.
Evaluation of the immunohistochemical expression of p16 in colorectal carcinoma and correlate its expression to different clinical and pathological parameters as patients' ages, sexes, tumor location, histopathological phenotype, status of nodal involvement, perineural and lymphovascular invasion.
Detailed description
Colorectal Carcinoma is very common nowadays, with increasing need for further research.
p16 is tumor suppressor gene with a vital rule ; inactivation of p16 leads to tumor formation and progression.
50 Specimens will be collected from Pathology Department of Sohag University Hospital. Sufficient clinical and histopathological data will be attached for each case.
The previously processed formalin-fixed, paraffin-embedded tissue blocks will be used to get Hematoxylin \& Eosin stained sections to confirm the diagnosis and to detect the histopathological type, grade and stage of each tumor.
Another sliced tissue sections will be immunohistochemically stained with p16 monoclonal antibodies to be evaluated with the positivity, intensity and distribution of the detected stain.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | – | Biological: Immunohistochemical stainingFifty (50) cases of colorectal cancer will be performed from archieved formalin-fixed, paraffin-embedded tissue blocks referred to Pathology Department, Sohag University Hospitals. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Fifty (50) cases of colorectal cancer will be performed from archieved formalin-fixed, paraffin-embedded tissue blocks referred to Pathology Department, Sohag University Hospitals.
Key inclusion criteria (3 listed)
- Specimens from patients with colorectal cancer.
- Tissue blocks with sufficient material.
- Specimens with sufficient clinical data.
Key exclusion criteria (2 listed)
- Tissue blocks with insufficient, destroyed or necrotic material.
- Specimens with insufficient 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 stainingImmunohistochemical staining of paraffin embedded blocks of colorectal carcinoma tissues by p16 monoclonal antibodies to be evaluated with the positivity, intensity and distribution of the detected stain. | Biological | Participants |
Primary outcome
Evaluation of p16 Expression in Colorectal Carcinoma.
Time frame: 6 months
Immunohistochemical staining of Colorectal tissues by p16 monoclonal antibody
1 secondary outcome
Correlation of p16 expression to different clinical and pathological parameters
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
- Individual participant dataSharing planned: Undecided. Not decided yet
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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.
Sherry R Azmy, Demonstrator of pathology contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Carcinoma, run by Sohag University at 1 site in Egypt.
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 2 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: looking for participants now, as of the sponsor's last update on 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sherry R Azmy, Demonstrator of pathology (01507557371 ext. 01207589093, shery.raoof@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of p16 Expression in Colorectal Carcinoma. (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 10 Jul 2025.