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The Characterisation of RT Caries.

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ClinicalTrials.gov Identifier: NCT03397823
Recruitment Status : Recruiting
First Posted : January 12, 2018
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):
King's College London

Brief Summary:

Head and neck cancer represent 4-5% of all of cancer diagnosed in the UK, the first choice of treatment it is Radiotherapy (RT). RT is known to produce a wide range of oral side effects such as hypo-salivation, caries, xerostomia, mucositis and osteoradionecrosis.

Hypo-salivation may lead to a shift in diversity of the bacterial population altering oral homeostasis. RT may also cause a variation in saliva protein composition which can affect its rheological properties and host defence increasing the possibility of caries development. Additionally, the effects of RT on the organic and inorganic structure/ composition of teeth and the possible relation with caries risk have not been investigated so far.

Mucositis is another frequent oral complication of RT and it is estimated that more than 80% of the treated patients will develop this condition.

Longitudinal studies assessing all these conditions before and after cancer treatment have not been reported in literature to date.

Therefore, the main objective of the proposed study is to assess the chemical composition of the dentine matrix, the variations in salivary proteins and in oral microbiome occurring in Head & Neck cancer patients undergoing RT. These data will be collected and a complete oral assessment with 18 month follow up will be performed. All these data will be computed to demonstrate the associations between RT and caries risk to demonstrate possible mechanistic causes.


Condition or disease
Head and Neck Cancer Radiotherapy Side Effect

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 102 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: The Characterisation of Therapeutic Radiation-induced Caries; the Histopathological, Ultrastructural and Microbial Changes Affecting Its Prevention and Treatment.
Actual Study Start Date : February 15, 2017
Estimated Primary Completion Date : December 30, 2018
Estimated Study Completion Date : June 1, 2019

Resource links provided by the National Library of Medicine


Group/Cohort
head and neck cancer pre RT
head and neck cancer patients before and after RT
head and neck cancer treated
head and neck cancer patients treated with radiotherapy
healthy control
subjects matched in gender and age without cancer



Primary Outcome Measures :
  1. radiotherapy effects on oral microbiota [ Time Frame: until October 2019 ]
    To perform high throughput sequencing techniques on saliva, caries and oral swab samples to detect bacterial species prevalence. DNA extraction will be performed in order to characterise the microbial diversity of the oral biofilm, whole mouth saliva, and caries of head and neck cancer patients before and after radiotherapy and compare with healthy control subjects using Illumina sequencing platform.


Secondary Outcome Measures :
  1. radiotherapy effects on salivary proteins [ Time Frame: 2019 ]
    In order to determinate the shift in saliva protein composition it will be analysed; total protein content and specific proteins concentration. Total protein concentration in saliva obtained from all subjects will be determinate using BCA assay, then using enzyme linked immunosorbent assay (ELISA) to quantify the presence of targeted proteins.

  2. radiotherapy effects on dentine matrix [ Time Frame: 2019 ]
    To image dentine samples by two-photon microscopy and quantify possible variations in collagen content by image J analysis programme.



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Head and neck cancer patients treated with radiotherapy control matched age and gender
Criteria

Inclusion Criteria:

Head and Neck Cancer Patients Male or female Over the age of 16. Received radiation treatment for Head and Neck cancer

Control:

  1. Male or female
  2. Over the age of 16
  3. Good general health
  4. Permanent dentition at least 20 teeth

Exclusion Criteria:

Subjects younger than 16. Patients unable to give consent. Patients who have been administered antibiotics in the previous month.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03397823


Contacts
Contact: maria gonzalez 7470223082 maria.i.gonzalez@kcl.ac.uk

Locations
United Kingdom
kings college london, Guy's Hospital Recruiting
London, United Kingdom, SE1 9RT
Contact: maria gonzalez    7470223082    maria.i.gonzalez@kcl.ac.uk   
Principal Investigator: avijit banerjee, professor         
Sponsors and Collaborators
King's College London
Investigators
Principal Investigator: avijit banerjee, professor King's College London

Responsible Party: King's College London
ClinicalTrials.gov Identifier: NCT03397823     History of Changes
Other Study ID Numbers: Radiotherapy caries
First Posted: January 12, 2018    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: the participants are allocated with a number its not possible to identify them

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms