Cancer of ColonNCT05553080
Significance of Immunohistochemical Expression of Fascin-1 in Colorectal Carcinoma
An observational study of Cancer of Colon, run by Sohag University at 2 sites in Egypt.
Trial summary
Colorectal carcinoma is a major health problem. As a malignant tumor, the malignant potential of colorectal carcinoma is based mainly on its ability to metastasis to different sites. Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- Cancer of Colon
- What is being tested?
- Immunohistochemistry
- How many people
- 60 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Jan 2022to 1 Dec 2022
- 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 30 to 90 years
- All sexes
- Adult, Older adult
Study population: Patients had colorectal carcinoma who underwent radical colectomy operations in Sohag University Hospital, Sohag, Egypt.
Who may be able to join
- All cases of colorectal carcinoma.
Who cannot join
- cases diagnosed on basis of lower endoscopic biopsies or local resections without radical colectomy.
- Patients with preopoerative history of chemo or radiotherapy.
- Patients with poor clinical data.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Maisa Hashem Mohammed
Sohag, 82524
Sohag faculty of medicine
Sohag, 82524
About this study
Colorectal carcinoma is a major health problem. As a malignant tumor, the malignant potential of colorectal carcinoma is based mainly on its ability to metastasis to different sites. Fascin-1 is an actin binding protein which is involved in reconstruction of intracellular actin network, the latter enforces the neoplastic cell to invade surrounding structures.
Read the detailed description
colorectal carcinoma is an aggressive malignant tumor. It has high incidence of cancer-related morbidity and mortality. the malignant potential of a given neoplasm is based mainly on its ability to invade the surrounding vasculature and reach to distant sites, the latter is called metastasis. in order to metastasize to distant sites, the neoplastic cells must re-arrange the intracellular actin filaments into well formed intracellular assembly which enable the neoplastic cells to reach to distant sites. Fascin-1 is an actin binding protein, it is involved in reconstruction of actin assembly. fortunately, Fascin-1 could be blocked by newly developed medications, blocking of Fascin-1 may limit the metastasis of colorectal carcinoma. in current study the investigators detect Fascin-1 in colorectal carcinoma by immunohistochemical approach, then they correlated different levels of Fascin-1 expression to tumor clinical and pathological criteria as patients' ages, sexes, tumor stages, nodal metastasis, vascular and per-ineural invasions.
- Conditions
- Cancer of Colon
- Being tested
- Immunohistochemistry
- Keywords
- Cancer Colon, Fascin-1, Actin assembly
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImmunohistochemistryGenetic
immunohistochemical staining of colorectal carcinoma specimens by anti human fascin antibody.
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of immunohistochemical staining of colorectal carcinoma by Fascin-1
correlation of different levels of Fascin-1 expression to patients' ages, sexes, tumor stage, nodal metastasis, vascular and perineural invasion.
Measured: September , 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start1 Jan 2022
- Primary completion30 Sep 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of ColonStudies 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
- Prospective
- Enrolment
- 60 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
- NCT05553080
- Sponsor's protocol ID
- Soh-Med-22-09-14
- Status last verified
- Oct 2022
- First submitted
- 21 Sep 2022
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- 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 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Significance of Immunohistochemical Expression of Fascin-1 in Colorectal Carcinoma
- ClinicalTrials.gov ID
- NCT05553080
- Acronym / sponsor ID
- Soh-Med-22-09-14
- Conditions
- Cancer of Colon
- Keywords
- Cancer Colon, Fascin-1, Actin assembly
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 23 Sep 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.
Colorectal carcinoma is a major health problem. As a malignant tumor, the malignant potential of colorectal carcinoma is based mainly on its ability to metastasis to different sites. Fascin-1 is an actin binding protein which is involved in reconstruction of intracellular actin network, the latter enforces the neoplastic cell to invade surrounding structures.
Detailed description
colorectal carcinoma is an aggressive malignant tumor. It has high incidence of cancer-related morbidity and mortality. the malignant potential of a given neoplasm is based mainly on its ability to invade the surrounding vasculature and reach to distant sites, the latter is called metastasis. in order to metastasize to distant sites, the neoplastic cells must re-arrange the intracellular actin filaments into well formed intracellular assembly which enable the neoplastic cells to reach to distant sites. Fascin-1 is an actin binding protein, it is involved in reconstruction of actin assembly. fortunately, Fascin-1 could be blocked by newly developed medications, blocking of Fascin-1 may limit the metastasis of colorectal carcinoma. in current study the investigators detect Fascin-1 in colorectal carcinoma by immunohistochemical approach, then they correlated different levels of Fascin-1 expression to tumor clinical and pathological criteria as patients' ages, sexes, tumor stages, nodal metastasis, vascular and per-ineural invasions.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients had colorectal carcinoma who underwent radical colectomy operations in Sohag University Hospital, Sohag, Egypt.
Key inclusion criteria (1 listed)
- All cases of colorectal carcinoma.
Key exclusion criteria (3 listed)
- cases diagnosed on basis of lower endoscopic biopsies or local resections without radical colectomy.
- Patients with preopoerative history of chemo or radiotherapy.
- Patients with poor 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 |
|---|---|---|
| Immunohistochemistryimmunohistochemical staining of colorectal carcinoma specimens by anti human fascin antibody. | Genetic | – |
Primary outcome
Evaluation of immunohistochemical staining of colorectal carcinoma by Fascin-1
Time frame: September , 2022
correlation of different levels of Fascin-1 expression to patients' ages, sexes, tumor stage, nodal metastasis, vascular and perineural 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 12 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer of Colon, run by Sohag University at 2 sites 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 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: finished, as of the sponsor's last update on 12 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 2 sites 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?
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?
Evaluation of immunohistochemical staining of colorectal carcinoma by Fascin-1 (time frame: September , 2022). 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 12 Apr 2023.