Immunohistochemical Expression of Excision Repair Cross Complementation Group 1 (ERCC1) in Laryngeal Squamous Cell Carcinoma and Its Correlation With Response to Radiotherapy.

April 15, 2023 updated by: Marwa Mohamed Mohamed Abdel hameed, Assiut University
  1. Determine the correlation between immunohistochemical expression of ERCC1 in laryngeal cancer cells with clinico-pathological variables.
  2. Assess the correlation between ERCC1 expression and response to radiotherapy.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The global burden of laryngeal cancer increased during the past 3 decades. A total number of 210,606 new cases of laryngeal cancer have been diagnosed in 2017 (2.76 new cases per 100,000 inhabitants) worldwide, with a prevalence of 1.09 million cases (14.33 cases per 100,000 inhabitants), accounting for as many as 126,471 deaths (1.66 per 100,000 inhabitants). The incidence and prevalence have both increased by 12.0% and 23.8%, respectively during the past 3 decades, whilst mortality has declined by approximately 5 %.

In Egypt, laryngeal cancer represents 5.7% of all body malignancies and 38.7% of the head and neck malignancies.

Squamous cell carcinoma is the most common histologic variant and accounts for 85-95% of all malignant tumors of the larynx. According to World Health Organization it is the second most common malignancy of the upper aerodigestive tract. It occurs more in people above 40 years of age and more common in males.

The larger number of laryngeal cancer cases originate from the glottic region (i.e., approximately two-third), followed by the supraglottic area (about 30%), whilst trans-glottic and purely subglottic tumors are generally less frequent.

Excision repair cross-complementation group 1 (ERCC1) is a key DNA repair gene in the nucleotide excision repair pathway which is activated in the repair of intra- and interstrand DNA crosslink.

Ionizing radiation (IR) acts directly or indirectly to cause various forms of deoxyribonucleic acid (DNA) damage in cells. DNA damage repair is initiated after the cell is genetically damaged. Nucleotide-excision repair (NER) is one of the ways of DNA repair. ERCC1 is a structure-specific endonuclease that cut DNA at single-stranded/double-stranded junctions with a specific polarity.

There is some clinical evidence suggesting that ERCC1 status (ERCC1 mRNA expression, ERCC1 protein expression, and ERCC1 polymorphisms) is associated with platinum-based therapy efficacy in some kinds of cancers.

In a previous meta-analysis, ERCC1 protein low expression status detected by immunohistochemical methods significantly correlated with higher response to platinum-based chemotherapy in ovarian cancers.

Another meta-analysis evaluated non-small cell lung cancer patients treated with platinum-based chemoradiation showed that both low tumoral mRNA and protein levels were associated with a better response rate and overall patient survival.

In head and neck squamous cell carcinomas, the available studies have a conflict in results. Of six studies evaluating the relation between ERCC1 status and outcomes of head and neck cancer patients, three showed positive and another three were with negative results.

Study Type

Observational

Enrollment (Anticipated)

52

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patients with laryngeal squamous cell carcinoma that will be treated with radiotherapy.

Description

Inclusion Criteria:

  • Stage: All stages of laryngeal squamous cell carcinoma.
  • Grade: Both high and low grades.
  • Patients treated with radiotherapy.
  • Normal laryngeal tissue as a control.

Exclusion Criteria:

  • • Patients with deficient clinical data.

    • Patients treated with chemotherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Other: Immunohistochemistry
Immunohistochemical expression of ERCC1
Group 2
Other: Immunohistochemistry
Immunohistochemical expression of ERCC1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Investigate the immunohistochemical expression of ERCC1 in laryngeal squamous cell carcinoma and correlate between its expression and response to radiotherapy.
Time Frame: 12 months
Immunohistochemical staining for ERCC1 using monoclonal antibodies on paraffin blocks with immunoperoxidase technique will be assessed to detect expression of ERCC1 in laryngeal squamous cell carcinoma. Evaluation of ERCC1 expression depends on evaluating intensity and extent of staining.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2023

Primary Completion (Anticipated)

October 1, 2024

Study Completion (Anticipated)

January 1, 2025

Study Registration Dates

First Submitted

April 15, 2023

First Submitted That Met QC Criteria

April 15, 2023

First Posted (Actual)

April 27, 2023

Study Record Updates

Last Update Posted (Actual)

April 27, 2023

Last Update Submitted That Met QC Criteria

April 15, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ERCC1 in laryngeal cancers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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