NCT05293327

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 24, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

April 1, 2022

Status Verified

March 1, 2022

Enrollment Period

9 months

First QC Date

March 13, 2022

Last Update Submit

March 23, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Blocks obtained from laryngeal squamous cell carcinoma tissue previously extracted from patients treated in Sohag University Hospital

You may qualify if:

  • Laryngeal resection (total or partial laryngectomy) and biopsies.
  • Complete clinical data.

You may not qualify if:

  • Patients with recurrence of the primary tumor.
  • Patients with a history of preoperative chemotherapy and/or radiotherapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Sohag University

Sohag, 82511, Egypt

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsHead and Neck NeoplasmsNeoplasms by Site

Study Officials

  • Asmaa AM Abd El-latif

    Faculty of Medicine,Sohag University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Asmaa AM Abd El-latif

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturerof Pathology

Study Record Dates

First Submitted

March 13, 2022

First Posted

March 24, 2022

Study Start

June 1, 2022

Primary Completion

March 1, 2023

Study Completion

June 1, 2023

Last Updated

April 1, 2022

Record last verified: 2022-03

Locations