Salivary Cytokines as Biomarker for Oral Health

NCT02807519 | Completed

• 1 other identifier: UKBB-2016/011
• Study Type: observational
• Target: 128
• Locations: 1 country
• Sites: 3

Brief Summary

Oral complications during and after cancer treatment are common. A key role in maintaining oral health plays saliva. In the last decade numerous studies have investigated immunological biomarkers such as cytokines in saliva samples. In children, the few studies have investigated salivary cytokines (sCK) suggesting that these are associated with oral health (sCK). One study investigating sCK in adult oncology patients showed an association between Interleukin-6 (IL-6) and severity of oral chronic graft-versus-host disease (GVHD) in survivors of hematopoietic stem cell transplantation. Therefore determination of sCK concentrations may also be helpful for assessment of GVHD activity and other inflammatory processes in cancer patients. In pediatric oncology patients, to the investigators' knowledge, no study has so far investigated sCK concentrations as markers for oral or systemic health.

Conditions

Neoplasms

Keywords

Oral health; Saliva; Biomarker; Cytokines; Cancer; children

Outcome Measures

Primary Outcomes (3)

• mucositis (clinical oral finding)

  clinical oral finding as mucositis in children with a hematological/oncological disease and healthy control children

  18 months

• salivary cytokine (sCK) levels

  salivary cytokine (sCK) levels in children with a hematological/oncological disease and healthy control children

  18 months

• aphthous ulcer (clinical oral finding)

  clinical oral finding as aphthous ulcer in children with a hematological/oncological disease and healthy control children

  18 months

Study Arms (2)

Oncological patients

Children with confirmed haematological/oncological diagnosis who are admitted to the paediatric oncology ward at the Universitätsspital Beider Basel (UKBB), who will require radio- and/or chemotherapy . Collection of salivary cytokines will be performed in this group.

Genetic: collection of salivary cytokines

Control group

Healthy children which are seen routinely at the Schulzahnklinik/Volkzahnklinik Basel. Collection of salivary cytokines will be performed in this group.

Genetic: collection of salivary cytokines

Interventions

collection of salivary cytokines GENETIC

Collection of the saliva will be done following this procedure: The collection will be done prior to any other dental manipulation. The test person is sitting with its head tilted slightly forward. Initially, any saliva present in the mouth must be swallowed or spit out completely. Then, a paraffin gum is given to the test person. This paraffin gum must be chewed for minimally 2 and maximally up to 5 minutes. During the time period that the test person is chewing the paraffin gum, the saliva must be spitted into a cup repeatedly, or the saliva can also be let run passively into the cup. The amount of saliva is then weighted (1g equivalent to 1 ml) and a saliva flow rate (ml/min) is calculated and noted.

Control group; Oncological patients

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

* Children with a new haematological/oncological diagnosis * admitted to the paediatric oncology ward at the UKBB * who will require radio- and/or chemotherapy. Healthy children who present at the Schulzahnklinik respectively Volkszahnklinik for a dental prophylaxis

You may qualify if:

• Children with confirmed haematological/oncological disease and necessity for radio-or chemotherapy
• Age \> 4 and \< 18 years.

You may not qualify if:

• patients, who already were treated with radio- or chemotherapy
• patients with current or previous (last 7 days) symptoms of a respiratory infection, rhinitis, bronchitis and tonsillitis
• children with an autoimmune disease
• Use of systemic antibiotics within the last 2 weeks.
• Use of antimicrobial mouth rinsing solution within the last 12 hours,
• any vaccination within the last 48 hours
• known allergy to paraffin.

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Schulzahnklinik Basel: collaborator
• Volkszahnklinik Basel: collaborator

Study Sites (3)

Schulzahlklinik Basel

Basel, Canton of Basel-City, Switzerland

Location

Volkszahnklinik

Basel, Canton of Basel-City, Switzerland

Location

Kinderspital Aarau

Aarau, 5001, Switzerland

Location

Biospecimen

Retention: SAMPLES WITH DNA

Saliva sample collection. Cytokines analysis in the saliva

MeSH Terms

Conditions

Neoplasms

Study Officials

• Tamara Diesch, Dr.

  University Children's Hospital of Basel

  PRINCIPAL INVESTIGATOR

• Cornelia Filippi, Dr.

  University Centre of Dental Medicine Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2016
• First Posted: June 21, 2016
• Study Start: December 1, 2016
• Primary Completion: August 1, 2020
• Study Completion: January 1, 2021
• Last Updated: February 2, 2021

Record last verified: 2021-02

Locations

CH (3)