NCT05832593

Brief Summary

  1. 1.Determine the correlation between immunohistochemical expression of ERCC1 in laryngeal cancer cells with clinico-pathological variables.
  2. 2.Assess the correlation between ERCC1 expression and response to radiotherapy.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2023

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

April 15, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 27, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

April 27, 2023

Status Verified

April 1, 2023

Enrollment Period

1.4 years

First QC Date

April 15, 2023

Last Update Submit

April 15, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Investigate the immunohistochemical expression of ERCC1 in laryngeal squamous cell carcinoma and correlate between its expression and response to radiotherapy.

    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

Study Arms (2)

Group 1

Other: Immunohistochemistry

Group 2

Other: Immunohistochemistry

Interventions

Immunohistochemical expression of ERCC1

Group 1Group 2

Eligibility Criteria

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

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

You may qualify if:

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

You may not qualify if:

  • Patients with deficient clinical data.
  • Patients treated with chemotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (17)

  • Nocini R, Molteni G, Mattiuzzi C, Lippi G. Updates on larynx cancer epidemiology. Chin J Cancer Res. 2020 Feb;32(1):18-25. doi: 10.21147/j.issn.1000-9604.2020.01.03.

    PMID: 32194301BACKGROUND
  • Fasunla AJ, Ogundoyin OA, Onakoya PA, Nwaorgu OG. Malignant tumors of the larynx: Clinicopathologic profile and implication for late disease presentation. Niger Med J. 2016 Sep-Oct;57(5):280-285. doi: 10.4103/0300-1652.190596.

    PMID: 27833247BACKGROUND
  • Hoffman HT, Porter K, Karnell LH, Cooper JS, Weber RS, Langer CJ, Ang KK, Gay G, Stewart A, Robinson RA. Laryngeal cancer in the United States: changes in demographics, patterns of care, and survival. Laryngoscope. 2006 Sep;116(9 Pt 2 Suppl 111):1-13. doi: 10.1097/01.mlg.0000236095.97947.26.

    PMID: 16946667BACKGROUND
  • Markou K, Christoforidou A, Karasmanis I, Tsiropoulos G, Triaridis S, Constantinidis I, Vital V, Nikolaou A. Laryngeal cancer: epidemiological data from Nuorthern Greece and review of the literature. Hippokratia. 2013 Oct;17(4):313-8.

    PMID: 25031508BACKGROUND
  • Avinash Tejasvi ML, Maragathavalli G, Putcha UK, Ramakrishna M, Vijayaraghavan R, Anulekha Avinash CK. Impact of ERCC1 gene polymorphisms on response to cisplatin based therapy in oral squamous cell carcinoma (OSCC) patients. Indian J Pathol Microbiol. 2020 Oct-Dec;63(4):538-543. doi: 10.4103/IJPM.IJPM_964_19.

    PMID: 33154302BACKGROUND
  • Jiang C, Guo Y, Li Y, Kang J, Sun X, Wu H, Feng J, Xu Y. The association between the ERCC1/2 polymorphisms and radiotherapy efficacy in 87 patients with non-small cell lung cancer. J Thorac Dis. 2021 May;13(5):3126-3136. doi: 10.21037/jtd-21-755.

    PMID: 34164203BACKGROUND
  • Vilmar A, Sorensen JB. Excision repair cross-complementation group 1 (ERCC1) in platinum-based treatment of non-small cell lung cancer with special emphasis on carboplatin: a review of current literature. Lung Cancer. 2009 May;64(2):131-9. doi: 10.1016/j.lungcan.2008.08.006. Epub 2008 Sep 19.

    PMID: 18804893BACKGROUND
  • Bohanes P, Labonte MJ, Lenz HJ. A review of excision repair cross-complementation group 1 in colorectal cancer. Clin Colorectal Cancer. 2011 Sep;10(3):157-64. doi: 10.1016/j.clcc.2011.03.024. Epub 2011 Apr 28.

    PMID: 21855036BACKGROUND
  • Langer CJ. Exploring biomarkers in head and neck cancer. Cancer. 2012 Aug 15;118(16):3882-92. doi: 10.1002/cncr.26718. Epub 2012 Jan 26.

    PMID: 22281752BACKGROUND
  • Li FY, Ren XB, Xie XY, Zhang J. Meta-analysis of excision repair cross-complementation group 1 (ERCC1) association with response to platinum- based chemotherapy in ovarian cancer. Asian Pac J Cancer Prev. 2013;14(12):7203-6. doi: 10.7314/apjcp.2013.14.12.7203.

    PMID: 24460276BACKGROUND
  • Chen S, Zhang J, Wang R, Luo X, Chen H. The platinum-based treatments for advanced non-small cell lung cancer, is low/negative ERCC1 expression better than high/positive ERCC1 expression? A meta-analysis. Lung Cancer. 2010 Oct;70(1):63-70. doi: 10.1016/j.lungcan.2010.05.010. Epub 2010 Jun 11.

    PMID: 20541281BACKGROUND
  • Jun HJ, Ahn MJ, Kim HS, Yi SY, Han J, Lee SK, Ahn YC, Jeong HS, Son YI, Baek JH, Park K. ERCC1 expression as a predictive marker of squamous cell carcinoma of the head and neck treated with cisplatin-based concurrent chemoradiation. Br J Cancer. 2008 Jul 8;99(1):167-72. doi: 10.1038/sj.bjc.6604464.

    PMID: 18594541BACKGROUND
  • Fountzilas G, Bamias A, Kalogera-Fountzila A, Karayannopoulou G, Bobos M, Athanassiou E, Kalogeras KT, Tolis C, Tsekeris P, Papakostas P, Vamvouka C, Zaramboukas T, Kosmidis P, Zamboglou N, Misailidou D. Induction chemotherapy with docetaxel and cisplatin followed by concomitant chemoradiotherapy in patients with inoperable non-nasopharyngeal carcinoma of the head and neck. Anticancer Res. 2009 Feb;29(2):529-38.

    PMID: 19331199BACKGROUND
  • Handra-Luca A, Hernandez J, Mountzios G, Taranchon E, Lacau-St-Guily J, Soria JC, Fouret P. Excision repair cross complementation group 1 immunohistochemical expression predicts objective response and cancer-specific survival in patients treated by Cisplatin-based induction chemotherapy for locally advanced head and neck squamous cell carcinoma. Clin Cancer Res. 2007 Jul 1;13(13):3855-9. doi: 10.1158/1078-0432.CCR-07-0252.

    PMID: 17606717BACKGROUND
  • Fountzilas G, Kalogera-Fountzila A, Lambaki S, Wirtz RM, Nikolaou A, Karayannopoulou G, Bobos M, Kotoula V, Murray S, Lambropoulos A, Aravantinos G, Markou K, Athanassiou E, Misailidou D, Kalogeras KT, Skarlos D. MMP9 but Not EGFR, MET, ERCC1, P16, and P-53 Is Associated with Response to Concomitant Radiotherapy, Cetuximab, and Weekly Cisplatin in Patients with Locally Advanced Head and Neck Cancer. J Oncol. 2009;2009:305908. doi: 10.1155/2009/305908. Epub 2009 Dec 29.

    PMID: 20066159BACKGROUND
  • Koh Y, Kim TM, Jeon YK, Kwon TK, Hah JH, Lee SH, Kim DW, Wu HG, Rhee CS, Sung MW, Kim CW, Kim KH, Heo DS. Class III beta-tubulin, but not ERCC1, is a strong predictive and prognostic marker in locally advanced head and neck squamous cell carcinoma. Ann Oncol. 2009 Aug;20(8):1414-9. doi: 10.1093/annonc/mdp002. Epub 2009 May 25.

    PMID: 19468031BACKGROUND
  • Hayes M, Lan C, Yan J, Xie Y, Gray T, Amirkhan RH, Dowell JE. ERCC1 expression and outcomes in head and neck cancer treated with concurrent cisplatin and radiation. Anticancer Res. 2011 Dec;31(12):4135-9.

    PMID: 22199271BACKGROUND

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Immunohistochemistry

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

HistocytochemistryCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHistological TechniquesInvestigative TechniquesImmunologic Techniques

Central Study Contacts

Marwa Abdelhameed, masters

CONTACT

Abeer Refaiy, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adminstrator in Pathology department, Faculty Of Medicine

Study Record Dates

First Submitted

April 15, 2023

First Posted

April 27, 2023

Study Start

May 1, 2023

Primary Completion

October 1, 2024

Study Completion

January 1, 2025

Last Updated

April 27, 2023

Record last verified: 2023-04