Laryngeal Squamous Cell CarcinomaIMP3PCNANCT05293327
IMP3 and PCNA Expression in Laryngeal Squamous Cell Carcinoma in Sohag Governorate
An observational study of Laryngeal Squamous Cell Carcinoma, run by Sohag University at 1 site in Egypt.
Trial summary
Laryngeal cancer is responsible for 2-5% of all new cancer cases worldwide. Squamous cell carcinoma of the larynx (LSCC) is the most common malignant tumor of the larynx, accounting for 85-90% of all laryngeal malignancies. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Laryngeal Squamous Cell Carcinoma
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- Jun 2022to Jun 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Blocks obtained from laryngeal squamous cell carcinoma tissue previously extracted from patients treated in Sohag University Hospital
Who may be able to join
- Laryngeal resection (total or partial laryngectomy) and biopsies.
- Complete clinical data.
Who cannot join
- Patients with recurrence of the primary tumor.
- Patients with a history of preoperative chemotherapy and/or radiotherapy.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine, Sohag University
Sohag, 82511
About this study
Official title: Immunohistochemical IMP3 and PCNA Expression as Diagnostic and Prognostic Markers in Laryngeal Squamous Cell Carcinoma in Sohag Governorate
Laryngeal cancer is responsible for 2-5% of all new cancer cases worldwide. Squamous cell carcinoma of the larynx (LSCC) is the most common malignant tumor of the larynx, accounting for 85-90% of all laryngeal malignancies.
Despite significant therapeutic developments in recent decades, increases in patients' 5-year survival rates are still minimal , which is likely due to late-stage diagnosis and other complex factors. Therefore, to improve the outcome, timely diagnosis, selection of the most appropriate therapy, and an adequate follow-up approach is needed.
Read more
The insulin-like growth factor II m-RNA-binding protein 3 (IMP3) is a new biomarker that may be implicated in the carcinogenesis of various malignancies, including head and neck squamous cell carcinoma. IMP3 normally expressed in embryonic tissue but decreases after birth and is no longer detectable in adult tissue With the exception of a few tissues. As a result, IMP3 is expressed only in tumors and not in neighboring normal tissues.
Proliferating Cell Nuclear Antigen (PCNA) is a nuclear protein that acts as a cell proliferation marker. In most forms of solid malignancies, such as colorectal cancer and breast cancer, PCNA is closely linked to prognosis and survival.
In this study, hoping to improve diagnosis of LSCC and assess prognosis better by using both IMP3 and PCNA biomarkers. As IMP3 may have a role in cell growth and proliferation and PCNA is a marker of cell proliferation; studying the association between both markers in laryngeal carcinoma is recommended.
- Conditions
- Laryngeal Squamous Cell Carcinoma
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis and prognosis of Laryngeal Squamous Cell Carcinoma
Immunohistochemical Expression of IMP3 and PCNA in Laryngeal Squamous Cell Carcinoma
Measured: One or two days after staining sections with the markers
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study startJun 2022 (estimated)
- Primary completionMar 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laryngeal Squamous Cell 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
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Abdo Mohammed Abd El-latif, Sohag University
- Investigators
- Asmaa AM Abd El-latif, Principal investigator, Faculty of Medicine,Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05293327
- Sponsor's protocol ID
- Soh-Med-22-03-01
- Acronym
- IMP3PCNA
- Status last verified
- Mar 2022
- First submitted
- 13 Mar 2022
- Last updated
- 1 Apr 2022
- 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 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunohistochemical IMP3 and PCNA Expression as Diagnostic and Prognostic Markers in Laryngeal Squamous Cell Carcinoma in Sohag Governorate
- ClinicalTrials.gov ID
- NCT05293327
- Acronym / sponsor ID
- IMP3PCNA / Soh-Med-22-03-01
- Conditions
- Laryngeal Squamous Cell Carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Jun 2022 (estimated)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 24 Mar 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.
Laryngeal cancer is responsible for 2-5% of all new cancer cases worldwide. Squamous cell carcinoma of the larynx (LSCC) is the most common malignant tumor of the larynx, accounting for 85-90% of all laryngeal malignancies.
Despite significant therapeutic developments in recent decades, increases in patients' 5-year survival rates are still minimal , which is likely due to late-stage diagnosis and other complex factors. Therefore, to improve the outcome, timely diagnosis, selection of the most appropriate therapy, and an adequate follow-up approach is needed.
The insulin-like growth factor II m-RNA-binding protein 3 (IMP3) is a new biomarker that may be implicated in the carcinogenesis of various malignancies, including head and neck squamous cell carcinoma. IMP3 normally expressed in embryonic tissue but decreases after birth and is no longer detectable in adult tissue With the exception of a few tissues. As a result, IMP3 is expressed only in tumors and not in neighboring normal tissues.
Proliferating Cell Nuclear Antigen (PCNA) is a nuclear protein that acts as a cell proliferation marker. In most forms of solid malignancies, such as colorectal cancer and breast cancer, PCNA is closely linked to prognosis and survival.
In this study, hoping to improve diagnosis of LSCC and assess prognosis better by using both IMP3 and PCNA biomarkers. As IMP3 may have a role in cell growth and proliferation and PCNA is a marker of cell proliferation; studying the association between both markers in laryngeal carcinoma is recommended.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Blocks obtained from laryngeal squamous cell carcinoma tissue previously extracted from patients treated in Sohag University Hospital
Key inclusion criteria (2 listed)
- Laryngeal resection (total or partial laryngectomy) and biopsies.
- Complete clinical data.
Key exclusion criteria (2 listed)
- Patients with recurrence of the primary tumor.
- Patients with a history of preoperative chemotherapy and/or radiotherapy.
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 Laryngeal Squamous Cell Carcinoma
Time frame: One or two days after staining sections with the markers
Immunohistochemical Expression of IMP3 and PCNA in Laryngeal Squamous Cell Carcinoma
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2022.
- 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.
Asmaa AM Abd El-latif principal investigator
Faculty of Medicine,Sohag University
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 Laryngeal Squamous Cell 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 2 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: status not confirmed, as of the sponsor's last update on 1 Apr 2022. 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 Asmaa AM Abd El-latif (+201010444557, zonazszs@hotmail.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 Laryngeal Squamous Cell Carcinoma (time frame: One or two days after staining sections with the markers). 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 1 Apr 2022.