Ignite Creation Date:
2024-05-06 @ 6:56 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05832593
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-04-27
First Post:
2023-04-15
Brief Title:
Immunohistochemical Expression of Excision Repair Cross Complementation Group 1 ERCC1 in Laryngeal Squamous Cell Carcinoma and Its Correlation With Response to Radiotherapy
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Immunohistochemical Expression of Excision Repair Cross Complementation Group 1 ERCC1 in Laryngeal Squamous Cell Carcinoma and Its Correlation With Response to Radiotherapy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
2 Assess the correlation between ERCC1 expression and response to radiotherapy
Detailed Description:
The global burden of laryngeal cancer increased during the past 3 decades A total number of 210606 new cases of laryngeal cancer have been diagnosed in 2017 276 new cases per 100000 inhabitants worldwide with a prevalence of 109 million cases 1433 cases per 100000 inhabitants accounting for as many as 126471 deaths 166 per 100000 inhabitants The incidence and prevalence have both increased by 120 and 238 respectively during the past 3 decades whilst mortality has declined by approximately 5
In Egypt laryngeal cancer represents 57 of all body malignancies and 387 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 ie 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-strandeddouble-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
In Egypt laryngeal cancer represents 57 of all body malignancies and 387 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 ie 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-strandeddouble-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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None