Head and Neck Squamous Cell CarcinomaCOMRAD-HNSCCNCT05156177
Correlation of Fecal Microbiome and Its Metabolites With Outcome of Radiotherapy in Head and Neck Carcinoma
An observational study of Head and Neck Squamous Cell Carcinoma, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
Trial summary
Preclinical studies have shown that the response of solid tumors and normal tissues to radiotherapy can be regulated by gut microbiota and its metabolites. In this study, the composition of gut microbiota in patients with locally advanced head and neck cancers undergoing definitive radiotherapy will be analysed… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma
- How many people
- 40 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Dec 2021to Dec 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult subjects diagnosed with locoregionally-advanced head and neck squamous cell carcinoma being treated with definitive radiotherapy with or without concurrent chemotherapy at the Institute of Oncology Ljubljana.
Who may be able to join
- Signed written and voluntary informed consent.
- Patient must be willing and able to provide collection for stool specimen analyses at 2 time points.
- Age > 18 years, male or female.
- Patient must be diagnosed with histologically confirmed squamous cell carcinoma of the head and neck (oral cavity, oropharynx, larynx, hypopharynx, or nasopharynx).
- Patients must be eligible for curative-intent treatment with either radiotherapy or concurrent chemo-radiotherapy.
- Overall disease stage III-IV based on 8th edition of American Joint Committee on Cancer staging system.
Who cannot join
- Receipt of induction chemotherapy.
- Presence of distant metastases.
- Any previous head and neck cancer.
- Any other known concurrent malignant disease.
- Any condition that, in the opinion of the Investigator, would interfere with patient safety, or evaluation of the collected specimen and interpretation of study result.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation of Fecal Microbiome and Its Metabolites With Outcome of Radiotherapy in Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (COMRAD-HNSCC)
Preclinical studies have shown that the response of solid tumors and normal tissues to radiotherapy can be regulated by gut microbiota and its metabolites. In this study, the composition of gut microbiota in patients with locally advanced head and neck cancers undergoing definitive radiotherapy will be analysed together with bacterial metabolites in stool and blood and a possible correlation with treatment outcome and treatment toxicity will be determined.
Read the detailed description
Head and neck cancer patients commonly present with unresectable locoregionally advanced disease in which radiotherapy is the mainstay of curative-intent treatment albeit at the cost of substantial acute and late toxicity. Recently discovered mechanisms by which gut microbiota and its metabolites impact tumor's and normal tissue's response to radiotherapy offer new ways to improve the therapeutic index of radiotherapy in solid tumors.
COMRAD-HNSCC is a prospective study assessing the correlation between gut microbiota composition and its metabolites and the response to radiotherapy in patients with unresectable locoregionally advanced head and neck cancer. Stool and serum samples will be collected at the beginning and at the end of curative radiotherapy treatment. The composition of gut microbiota will be analysed by ribosomal DNA high-throughput amplicon sequencing of the DNA isolated from stool samples, whereas targeted metabolomics using liquid chromatography-mass spectrometry will be performed on stool and serum samples.
The long-term goal of this study is to deepen the understanding of the role of gut microbiome and its metabolites in efficacy and toxicity of radiotherapy in head and neck cancer, and provide a basis for subsequent exploration to increase therapeutic index by regulating gut microbiota.
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Keywords
- Radiotherapy, Microbiome, Metabolites
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Objective response rate to radiotherapy according to RECIST 1.1 criteria as measured with computed tomography.
Associations with differences in fecal microbiota composition and in bacterial metabolites will be made between responders and non-responders.
Measured: 3 months post-treatment
Acute radiation induced mucositis and dermatitis
Acute radiation induced mucositis and dermatitis according to CTCAE v3.0 as measured with clinical examination.
Associations with differences in fecal microbiota composition and in bacterial metabolites will be made between patients with a maximum Grade ≤ 2 versus those with a maximum Grade > 3 acute radiation induced mucositis and dermatitis.
Measured: Up to 3 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2021
- Study start1 Dec 2021
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Oncology Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gaber Plavc, Institute of Oncology Ljubljana
- Investigators
- Gaber Plavc, MD, Principal investigator, Institute of Oncology Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05156177
- Sponsor's protocol ID
- ERIDEK-0052/2021
- Acronym
- COMRAD-HNSCC
- Status last verified
- Mar 2024
- First submitted
- 14 Nov 2021
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Fecal Microbiome and Its Metabolites With Outcome of Radiotherapy in Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (COMRAD-HNSCC)
- ClinicalTrials.gov ID
- NCT05156177
- Acronym / sponsor ID
- COMRAD-HNSCC / ERIDEK-0052/2021
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Keywords
- Radiotherapy, Microbiome, Metabolites
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Institute of Oncology LjubljanaUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 14 Dec 2021 (actual)
- 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.
Preclinical studies have shown that the response of solid tumors and normal tissues to radiotherapy can be regulated by gut microbiota and its metabolites. In this study, the composition of gut microbiota in patients with locally advanced head and neck cancers undergoing definitive radiotherapy will be analysed together with bacterial metabolites in stool and blood and a possible correlation with treatment outcome and treatment toxicity will be determined.
Detailed description
Head and neck cancer patients commonly present with unresectable locoregionally advanced disease in which radiotherapy is the mainstay of curative-intent treatment albeit at the cost of substantial acute and late toxicity. Recently discovered mechanisms by which gut microbiota and its metabolites impact tumor's and normal tissue's response to radiotherapy offer new ways to improve the therapeutic index of radiotherapy in solid tumors.
COMRAD-HNSCC is a prospective study assessing the correlation between gut microbiota composition and its metabolites and the response to radiotherapy in patients with unresectable locoregionally advanced head and neck cancer. Stool and serum samples will be collected at the beginning and at the end of curative radiotherapy treatment. The composition of gut microbiota will be analysed by ribosomal DNA high-throughput amplicon sequencing of the DNA isolated from stool samples, whereas targeted metabolomics using liquid chromatography-mass spectrometry will be performed on stool and serum samples.
The long-term goal of this study is to deepen the understanding of the role of gut microbiome and its metabolites in efficacy and toxicity of radiotherapy in head and neck cancer, and provide a basis for subsequent exploration to increase therapeutic index by regulating gut microbiota.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult subjects diagnosed with locoregionally-advanced head and neck squamous cell carcinoma being treated with definitive radiotherapy with or without concurrent chemotherapy at the Institute of Oncology Ljubljana.
Key inclusion criteria (6 listed)
- Signed written and voluntary informed consent.
- Patient must be willing and able to provide collection for stool specimen analyses at 2 time points.
- Age > 18 years, male or female.
- Patient must be diagnosed with histologically confirmed squamous cell carcinoma of the head and neck (oral cavity, oropharynx, larynx, hypopharynx, or nasopharynx).
- Patients must be eligible for curative-intent treatment with either radiotherapy or concurrent chemo-radiotherapy.
Key exclusion criteria (5 listed)
- Receipt of induction chemotherapy.
- Presence of distant metastases.
- Any previous head and neck cancer.
- Any other known concurrent malignant disease.
- Any condition that, in the opinion of the Investigator, would interfere with patient safety, or evaluation of the collected specimen and interpretation of study result.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Objective response rate
Time frame: 3 months post-treatment
Objective response rate to radiotherapy according to RECIST 1.1 criteria as measured with computed tomography. Associations with differences in fecal microbiota composition and in bacterial metabolites will be made between responders and non-responders.
Acute radiation induced mucositis and dermatitis
Time frame: Up to 3 months post-treatment
Acute radiation induced mucositis and dermatitis according to CTCAE v3.0 as measured with clinical examination. Associations with differences in fecal microbiota composition and in bacterial metabolites will be made between patients with a maximum Grade ≤ 2 versus those with a maximum Grade > 3 acute radiation induced mucositis and dermatitis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
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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.
Gaber Plavc, MD principal investigator
Institute of Oncology Ljubljana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Squamous Cell Carcinoma, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. 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?
Results are not available in the source record.
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?
Objective response rate (time frame: 3 months post-treatment). The study lists 2 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 5 Mar 2024.