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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
52

Contacts and Locations

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Study Contact

Study Contact

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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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Group 1
Other: Immunohistochemistry
Immunohistochemical expression of ERCC1
Group 2
Other: Immunohistochemistry
Immunohistochemical expression of ERCC1

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

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Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 15, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 27, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 27, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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