A Phase 1 interventional study of acetylsalicylic acid and gene expression analysis in Precancerous Condition, sponsored by Institute of Head and Neck Studies and Education, United Kingdom. Completed at 2 sites in United Kingdom. Per ClinicalTrials.gov, last updated 2013-08-12.
Sponsored by Institute of Head and Neck Studies and Education, United Kingdom · Phase 1, Interventional, and Treatment
RATIONALE: Aspirin mouthwash may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase I trial is studying the side effects and best dose of aspirin mouthwash in treating patients with oral leukoplakia.
OBJECTIVES:
OUTLINE: All patients undergo tissue biopsy for histological diagnosis. Patients without a histological diagnosis of precancerous oral dysplasia undergo routine follow-up. Patients with a histological diagnosis of precancerous oral dysplasia are sequentially allocated to 1 of 4 treatment groups.
At the time of definitive surgical excision, the patient is asked to gargle with the last dose of acetylsalicylic acid mouthwash just before being anesthetized. A small biopsy of the dysplasia lesion is taken and examined for immediate effects of the acetylsalicylic acid mouthwash on the dysplasia lesion. The surgically excised tissue is treated in the same way as the initial biopsy tissue (i.e., half being used for routine histology to confirm the diagnosis and the other half for research purposes). Tissue samples are analyzed via enzyme immunosorbent assay, qRT-PCR, immunoblotting, ELISA, immunohistochemistry, gene array analysis, and microvessel density analysis.
Patients complete a questionnaire assessing local and general tolerability as well as adverse effects during the period of use of the mouthwash.
After completion of study treatment, patients are followed periodically.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
48 studies on the registry are indexed under Leukoplakia, Oral; 11 are open to participants now.
This study's planned enrollment of 40 is above the median of 36 across 23 interventional studies indexed under Leukoplakia, Oral.
Browse Leukoplakia, Oral studies →This is the only study on the registry with Institute of Head and Neck Studies and Education, United Kingdom as lead sponsor.
Compared within Leukoplakia, Oral, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Precancerous Conditions. The counts are of registry records indexed under each term, refreshed daily. How we classify →
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
No , including any of the following:
PRIOR CONCURRENT THERAPY:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PGE2 levels as assessed by enzyme immunosorbent assay
COX-1 and COX-2 mRNA as assessed by qRT-PCR
COX-1 and COX-2 protein expression as assessed by immunohistochemistry and quantified by immunoblotting to determine whether COX inhibition in oral dysplasia tissues is actually possible by use of the mouthwash formulation
Comparison of WHO histological grade and clinical size of dysplastic lesions before and after treatment and assessment of proliferating cell nuclear antigen
Tolerability and possible oral and other adverse effects using a questionnaire
VEGF mRNA expression as assessed by qRT-PCR
Protein expression as assessed by ELISA and immunohistochemistry for VEGFA
Global gene response of dysplastic tissue as assessed by Affymetrix gene expression microarrays
The record gives a start of Feb 2010, a primary completion of Oct 2011 and a completion of Oct 2011. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2010. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Aspirin