Colorectal CancerNCT05794737
Immunohistochemical Expression of Inhibin Beta A (INHBA) in Colorectal Carcinoma
An observational study of Colorectal Cancer, run by Sohag University at 1 site in Egypt.
Trial summary
A retrospective observational study to evaluate immunohistochemical expression of Inhibin Beta A (INHBA) in 60 cases of Colorectal Carcinoma, and compare levels of its expression to different clinicopathological criteria. Read more about this study
- Who is it for?
- Ages 35 to 90 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Immunohistochemical staining
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2021to 30 Jun 2024
- 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 35 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Archived Formalin-fixed, Paraffin-embedded tissue blocks belonged to patients suffered from colonic and/or rectal cancers. Patients were admitted to sohag university hospital and underwent colectomy and their colonic specimens were sent to Pathology Laboratory of the same hospital to ascertain diagnosis and tumor phenotype, from period Janurary 2021 to December 2022.
Who may be able to join
- Specimens from patients with Colorectal Carcinoma. 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.
Egypt1 site, 1 recruiting
- Recruiting
Sohag University hospitals
Sohag
Magdy M Amin, Professor
Mera A Fayez, Doctor, 01224890136, meraatef@med.sohag.edu.eg
About this study
A retrospective observational study to evaluate immunohistochemical expression of Inhibin Beta A (INHBA) in 60 cases of Colorectal Carcinoma, and compare levels of its expression to different clinicopathological criteria.
Read the detailed description
Colorectal Carcinoma is an aggressive malignant epithelial tumor with an observable high incidence. Tumor invasion and metastasis to distant sites are two important issues which determine patient's outcome, so detecting novel biological markers that are involved in tumor proliferation and invasion with subsequent targeting by future medical drugs will positively improve patient's prognosis.
Inhibin Beta A (INHBA) is a glycoprotein molecule that has a role in tumor cells proliferation and invasion in different human malignancies. The aim of this study is to detect expression of INHBA in 60 archived formalin-fixed Paraffin-embedded tissue blocks of patients suffered from Colorectal Carcinoma, and to correlate different levels of its expression to some studied clinical and pathological criteria (Age, Sex, Tumor size, location, depth of tumor invasion, status of regional lymph nodes, vascular and perineural invasion).
- Conditions
- Colorectal Cancer
- Being tested
- Immunohistochemical staining
- Keywords
- Inhibin Beta A, Colorectal Carcinoma, Immunohistochemistry
- 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
Staining of Colorectal Carcinoma tissue sections by monoclonal antibodies against human Inhibin Beta A by immunohistochemical procedures.
| Study group | Role | What they receive |
|---|---|---|
| Participants | 60 archived Formalin-fixed Paraffin-embedded tissue blocks of Colorectal Carcinoma will be obtained and sectioned. From each block; Two tissue sections will be prepared, one tissue section will be stained by Hematoxylin and Eosin to detect tumor phenotype and depth of invasion. Other tissue section will be immunohistochemically stained by Anti-Human INHBA. Receives: Biological: Immunohistochemical staining |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of INHBA in Colorectal Carcinoma.
Detection of expression of INHBA in Colorectal Carcinoma cells by immunohistochemical approach, using anti-human INHBA monoclonal antibody.
Measured: 6 months
Secondary outcomes (1)
Correlation between INHBA expression in Colorectal Carcinoma and clinicopathological parameters.
Correlation between different levels of INHBA expression in Colorectal Carcinoma cells and some clinical and pathological parameters as age, sex, tumor phenotype and nodal status.
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 posted3 Apr 2023
- Study start1 Jan 2021
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mera Atef Fayez, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05794737
- Sponsor's protocol ID
- Soh-Med-23-03-08MS
- Status last verified
- Mar 2023
- First submitted
- 20 Mar 2023
- Last updated
- 3 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunohistochemical Expression of Inhibin Beta A (INHBA) in Colorectal Carcinoma
- ClinicalTrials.gov ID
- NCT05794737
- Acronym / sponsor ID
- Soh-Med-23-03-08MS
- Conditions
- Colorectal Cancer
- Keywords
- Inhibin Beta A, Colorectal Carcinoma, Immunohistochemistry
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 3 Apr 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.
A retrospective observational study to evaluate immunohistochemical expression of Inhibin Beta A (INHBA) in 60 cases of Colorectal Carcinoma, and compare levels of its expression to different clinicopathological criteria.
Detailed description
Colorectal Carcinoma is an aggressive malignant epithelial tumor with an observable high incidence. Tumor invasion and metastasis to distant sites are two important issues which determine patient's outcome, so detecting novel biological markers that are involved in tumor proliferation and invasion with subsequent targeting by future medical drugs will positively improve patient's prognosis.
Inhibin Beta A (INHBA) is a glycoprotein molecule that has a role in tumor cells proliferation and invasion in different human malignancies. The aim of this study is to detect expression of INHBA in 60 archived formalin-fixed Paraffin-embedded tissue blocks of patients suffered from Colorectal Carcinoma, and to correlate different levels of its expression to some studied clinical and pathological criteria (Age, Sex, Tumor size, location, depth of tumor invasion, status of regional lymph nodes, vascular and perineural invasion).
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | – | Biological: Immunohistochemical staining60 archived Formalin-fixed Paraffin-embedded tissue blocks of Colorectal Carcinoma will be obtained and sectioned. From each block; Two tissue sections will be prepared, one tissue section will be stained by Hematoxylin and Eosin to detect tumor phenotype and depth of invasion. Other tissue section will be immunohistochemically stained by Anti-Human INHBA. |
Who may qualify
- Ages
- 35 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Archived Formalin-fixed, Paraffin-embedded tissue blocks belonged to patients suffered from colonic and/or rectal cancers. Patients were admitted to sohag university hospital and underwent colectomy and their colonic specimens were sent to Pathology Laboratory of the same hospital to ascertain diagnosis and tumor phenotype, from period Janurary 2021 to December 2022.
Key inclusion criteria (1 listed)
- Specimens from patients with Colorectal Carcinoma. Tissue blocks with sufficient material. Specimens with sufficient clinical data.
Key exclusion criteria (1 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 stainingStaining of Colorectal Carcinoma tissue sections by monoclonal antibodies against human Inhibin Beta A by immunohistochemical procedures. | Biological | Participants |
Primary outcome
Detection of INHBA in Colorectal Carcinoma.
Time frame: 6 months
Detection of expression of INHBA in Colorectal Carcinoma cells by immunohistochemical approach, using anti-human INHBA monoclonal antibody.
1 secondary outcome
Correlation between INHBA expression in Colorectal Carcinoma and clinicopathological parameters.
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 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.
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 Cancer, 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 1 inclusion and 1 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 3 Apr 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mera A Fayez, Doctor (01224890136, meraatef@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of INHBA 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 3 Apr 2023.