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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05293327
Other study ID # Soh-Med-22-03-01
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 2022
Est. completion date June 2023

Study information

Verified date March 2022
Source Sohag University
Contact Asmaa AM Abd El-latif
Phone +201010444557
Email zonazszs@hotmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 70
Est. completion date June 2023
Est. primary completion date March 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: 1. Laryngeal resection (total or partial laryngectomy) and biopsies. 2. Complete clinical data. Exclusion Criteria: 1. Patients with recurrence of the primary tumor. 2. Patients with a history of preoperative chemotherapy and/or radiotherapy.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Egypt Faculty of Medicine, Sohag University Sohag

Sponsors (1)

Lead Sponsor Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Diagnosis and prognosis of Laryngeal Squamous Cell Carcinoma Immunohistochemical Expression of IMP3 and PCNA in Laryngeal Squamous Cell Carcinoma One or two days after staining sections with the markers
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