NeoplasmsCytosalNCT02807519
Salivary Cytokines as Biomarker for Oral Health
An observational study of Neoplasms, run by University Hospital, Basel, Switzerland at 3 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Neoplasms
- What is being tested?
- collection of salivary cytokines
- How many people
- 128 participants
- Where
- 3 sitesSwitzerland
- Study dates
- Dec 2016to Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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
Who may be able to join
- Children with confirmed haematological/oncological disease and necessity for radio-or chemotherapy
- Age > 4 and < 18 years.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Switzerland3 sites
Kinderspital Aarau
Aarau, 5001
Schulzahlklinik Basel
Basel, Canton of Basel-City
Volkszahnklinik
Basel, Canton of Basel-City
About this study
Official title: Salivary Cytokines in Paediatric Oncology Patients and Healthy Persons - A Pilot Study to Investigation of Biomarkers for Oral Health
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.
Read the detailed description
Oral complications are common during and after cancer treatment. Oral mucositis typically occurs during or immediately after chemotherapy and may lead to pain, oral and systemic infection, and nutritional compromise. Late effects of oral mucositis as a result of cancer treatment include an increased risk for dental caries, xerostomia and osteonecrosis. It has been recognised, that regular assessment of oral health, prevention and early treatment of oral mucositis decreases early and late complication rates.
Saliva plays a key role in maintaining oral health and reduced salivary flow contributes to acute disorders and long-term sequelae in oral health. Saliva is a complex fluid secreted by the salivary glands and the gingiva. In the last decade numerous studies have investigated immunological biomarkers such as cytokines in saliva samples. These studies included individuals with various oral and systemic diseases including oral cancer, oral caries, autoimmune and endocrine diseases, metabolic syndrome, chronic kidney disease and psychiatric illnesses.
In children, the few studies that have investigated salivary cytokines (sCK) suggest that these are associated with oral health (sCK). For example, one study in 114 healthy adolescent girls aged 11-17 years showed that sCK concentrations were generally not associated with levels in the serum . In addition this study also suggested that the sCK concentrations are age dependent.
However, a number of other studies suggest that sCK may also reflect systemic diseases such as shown in a study including 20 children aged 9-17 with allergies (including asthma, allergic rhinitis and eosinophilic esophagitis) showing that Th-2 cytokines were detectable in sCK.
One study investigating sCK in adult oncology patients showed an association between IL-6 and severity of oral chronic GVHD in survivors of a 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 paediatric oncology patients, to the investigators' knowledge, no study has so far investigated sCK concentrations as markers for oral or systemic health.
- Conditions
- Neoplasms
- Being tested
- collection of salivary cytokines
- Keywords
- Oral health, Saliva, Biomarker, Cytokines, Cancer, children
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collection of salivary cytokinesGenetic
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Genetic: collection of salivary cytokines |
What is being measured
The primary outcome is the main question the study is designed to answer.
mucositis (clinical oral finding)
clinical oral finding as mucositis in children with a hematological/oncological disease and healthy control children
Measured: 18 months
salivary cytokine (sCK) levels
salivary cytokine (sCK) levels in children with a hematological/oncological disease and healthy control children
Measured: 18 months
aphthous ulcer (clinical oral finding)
clinical oral finding as aphthous ulcer in children with a hematological/oncological disease and healthy control children
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2016 (estimated)
- Study startDec 2016
- Primary completionAug 2020
- Study completionJan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Schulzahnklinik Basel, Volkszahnklinik Basel
- Responsible party
- Sponsor
- Investigators
- Tamara Diesch, Dr., Principal investigator, University Children's Hospital BaselCornelia Filippi, Dr., Principal investigator, University Centre of Dental Medicine Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02807519
- Sponsor's protocol ID
- UKBB-2016/011
- Acronym
- Cytosal
- Status last verified
- Feb 2021
- First submitted
- 13 Jun 2016
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Salivary Cytokines in Paediatric Oncology Patients and Healthy Persons - A Pilot Study to Investigation of Biomarkers for Oral Health
- ClinicalTrials.gov ID
- NCT02807519
- Acronym / sponsor ID
- Cytosal / UKBB-2016/011
- Conditions
- Neoplasms
- Keywords
- Oral health, Saliva, Biomarker, Cytokines, Cancer, children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Schulzahnklinik Basel, Volkszahnklinik Basel
- Study start
- Dec 2016 (actual)
- Primary completion
- Aug 2020 (actual)
- Study completion
- Jan 2021 (actual)
- First posted
- 21 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Oral complications are common during and after cancer treatment. Oral mucositis typically occurs during or immediately after chemotherapy and may lead to pain, oral and systemic infection, and nutritional compromise. Late effects of oral mucositis as a result of cancer treatment include an increased risk for dental caries, xerostomia and osteonecrosis. It has been recognised, that regular assessment of oral health, prevention and early treatment of oral mucositis decreases early and late complication rates.
Saliva plays a key role in maintaining oral health and reduced salivary flow contributes to acute disorders and long-term sequelae in oral health. Saliva is a complex fluid secreted by the salivary glands and the gingiva. In the last decade numerous studies have investigated immunological biomarkers such as cytokines in saliva samples. These studies included individuals with various oral and systemic diseases including oral cancer, oral caries, autoimmune and endocrine diseases, metabolic syndrome, chronic kidney disease and psychiatric illnesses.
In children, the few studies that have investigated salivary cytokines (sCK) suggest that these are associated with oral health (sCK). For example, one study in 114 healthy adolescent girls aged 11-17 years showed that sCK concentrations were generally not associated with levels in the serum . In addition this study also suggested that the sCK concentrations are age dependent.
However, a number of other studies suggest that sCK may also reflect systemic diseases such as shown in a study including 20 children aged 9-17 with allergies (including asthma, allergic rhinitis and eosinophilic esophagitis) showing that Th-2 cytokines were detectable in sCK.
One study investigating sCK in adult oncology patients showed an association between IL-6 and severity of oral chronic GVHD in survivors of a 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 paediatric oncology patients, to the investigators' knowledge, no study has so far investigated sCK concentrations as markers for oral or systemic health.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oncological patients | – | Genetic: collection of salivary cytokinesChildren 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. |
| Control group | – | Genetic: collection of salivary cytokinesHealthy children which are seen routinely at the Schulzahnklinik/Volkzahnklinik Basel. Collection of salivary cytokines will be performed in this group. |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (2 listed)
- Children with confirmed haematological/oncological disease and necessity for radio-or chemotherapy
- Age > 4 and < 18 years.
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| collection of salivary cytokinesCollection 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. | Genetic | Control group, Oncological patients |
Primary outcome
mucositis (clinical oral finding)
Time frame: 18 months
clinical oral finding as mucositis in children with a hematological/oncological disease and healthy control children
salivary cytokine (sCK) levels
Time frame: 18 months
salivary cytokine (sCK) levels in children with a hematological/oncological disease and healthy control children
aphthous ulcer (clinical oral finding)
Time frame: 18 months
clinical oral finding as aphthous ulcer in children with a hematological/oncological disease and healthy control children
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tamara Diesch, Dr. principal investigator
University Children's Hospital Basel
Cornelia Filippi, Dr. principal investigator
University Centre of Dental Medicine Basel
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neoplasms, run by University Hospital, Basel, Switzerland at 3 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mucositis (clinical oral finding) (time frame: 18 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2021.