IMP3 and PCNA Expression in Laryngeal Squamous Cell Carcinoma in Sohag Governorate

Laryngeal Squamous Cell Carcinoma Clinical Trial

— IMP3PCNA  

Official title:

Immunohistochemical IMP3 and PCNA Expression as Diagnostic and Prognostic Markers in Laryngeal Squamous Cell Carcinoma in Sohag Governorate

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05293327
• Other study ID #: Soh-Med-22-03-01
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Laryngeal Squamous Cell Carcinoma
• Squamous Cell Carcinoma of Head and Neck

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