Radiation DermatitisNCT04268056
Characterization of Skin Microbiome Profile and it's Correlation to Radiation Dermatitis
An observational study of Radiation Dermatitis, run by AceTech at 1 site in Israel.
Trial summary
The purpose of this study is to characterize the skin microbiome profile of breast cancer patients before and after receiving Radio Therapy treatments, and evaluate the relationship between the microbiome profile and radiation dermatitis severity (grade) that the patient will develop. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Radiation Dermatitis
- What is being tested?
- Collection of skin culture samples
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Nov 2020to Nov 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with breast cancer undergoing radiation therapy.
Who may be able to join
- Age ≥ 18 years
- Histological confirmation of breast malignancy
- Primary or recurrent disease eligible
- Patients after breast lumpectomy and that scheduled to receive radiotherapy
- Patients that receive minimum of 45 Gy
- Ability to complete questionnaire(s) by themselves or with assistance
- Provide informed written consent
Who cannot join
- Patients with prior radiotherapy to any portion of the planned treatment site
- Tumour involvement of the skin
- Patients with active rash, pre-existing dermatitis, lupus, or scleroderma
- Patient with other skin diseases/ skin disorders
- Recent use of systemic or topical antibiotics or antifungal medications within 21 days of first swab collection.
- Recent use of any of the following within 21 days of first swab collection: o Systemic or topical steroids o Use of systemic immunosuppressant drugs o Use of ultraviolet light therapy
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- Prior usage of other topical and systemic medications within 21 days of first swab collection
- Prior usage of topical cosmetic products, creams, lotions, or gels within 14 days of first swab collection in areas where samples are taken.
- Clinical evidence of infection that in the judgement of the principle investigator would interfere with proper assessment of the skin microbiome
- Prior organ or bone marrow transplant
- Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the patient safety
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characterization of Skin Microbiome Profile Before and During Radiation Therapy and it's Correlation to the Occurrence and Severity of Radiation Dermatitis
The purpose of this study is to characterize the skin microbiome profile of breast cancer patients before and after receiving Radio Therapy treatments, and evaluate the relationship between the microbiome profile and radiation dermatitis severity (grade) that the patient will develop. Such characterizations can lead to potential biomarkers and/or therapeutic targets that can be used for the prognosis, prevention and treatment of this condition.
- Conditions
- Radiation Dermatitis
- Being tested
- Collection of skin culture samples
- Keywords
- Radiation dermatitis, Radio Therapy, Microbiome Profile
- Medical subject headings
- Radiodermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of skin culture samplesDiagnostic test
Collection of skin culture samples using a sterile swab. the swab will gently rubbed on the skin on the 3 different skin areas. The target areas are i) regions surrounding the RT treatment area (if possible, not from the scar area or from skin folds areas), ii) a control site of the normal (healthy) breast , iii) a control area on the forehead.
| Study group | Role | What they receive |
|---|---|---|
| RT patients | 100 patients with breast cancer undergoing radiation therapy Receives: Diagnostic Test: Collection of skin culture samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiation Dermatitis grade
Study participant will be evaluated by physician and nurse for the occurrence and the severity of RD. Skin condition (grade of RD) in the radiation area will be measured by the Radiation Therapy Oncology Group (RTOG) scoring.
Measured: through study completion, an average of 1 year
Microbiome composition
Collection of skin culture samples from body regions surrounding the RT treatment area and a control area
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Validation Procedure of evaluation of Radiation Dermatitis grade by the our application (Radia-App)
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2020
- Study start1 Nov 2020
- Primary completion20 Jul 2021
- Study completionNov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation DermatitisStudies 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
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- AceTech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roxolyana Abdah-Borthnyak, MD, Principal investigator, Director, Radiation Service for Female Cancer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04268056
- Sponsor's protocol ID
- 0141-19-RMB
- Status last verified
- Jul 2021
- First submitted
- 6 Feb 2020
- Last updated
- 21 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Skin Microbiome Profile Before and During Radiation Therapy and it's Correlation to the Occurrence and Severity of Radiation Dermatitis
- ClinicalTrials.gov ID
- NCT04268056
- Acronym / sponsor ID
- 0141-19-RMB
- Conditions
- Radiation Dermatitis
- Keywords
- Radiation dermatitis, Radio Therapy, Microbiome Profile
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- AceTechIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 20 Jul 2021 (actual)
- Study completion
- Nov 2021 (estimated)
- First posted
- 13 Feb 2020 (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.
The purpose of this study is to characterize the skin microbiome profile of breast cancer patients before and after receiving Radio Therapy treatments, and evaluate the relationship between the microbiome profile and radiation dermatitis severity (grade) that the patient will develop. Such characterizations can lead to potential biomarkers and/or therapeutic targets that can be used for the prognosis, prevention and treatment of this condition.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RT patients | – | Diagnostic Test: Collection of skin culture samples100 patients with breast cancer undergoing radiation therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with breast cancer undergoing radiation therapy.
Key inclusion criteria (7 listed)
- Age ≥ 18 years
- Histological confirmation of breast malignancy
- Primary or recurrent disease eligible
- Patients after breast lumpectomy and that scheduled to receive radiotherapy
- Patients that receive minimum of 45 Gy
Key exclusion criteria (11 listed)
- Patients with prior radiotherapy to any portion of the planned treatment site
- Tumour involvement of the skin
- Patients with active rash, pre-existing dermatitis, lupus, or scleroderma
- Patient with other skin diseases/ skin disorders
- Recent use of systemic or topical antibiotics or antifungal medications within 21 days of first swab collection.
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 skin culture samplesCollection of skin culture samples using a sterile swab. the swab will gently rubbed on the skin on the 3 different skin areas. The target areas are i) regions surrounding the RT treatment area (if possible, not from the scar area or from skin folds areas), ii) a control site of the normal (healthy) breast , iii) a control area on the forehead. | Diagnostic test | RT patients |
Primary outcome
Radiation Dermatitis grade
Time frame: through study completion, an average of 1 year
Study participant will be evaluated by physician and nurse for the occurrence and the severity of RD. Skin condition (grade of RD) in the radiation area will be measured by the Radiation Therapy Oncology Group (RTOG) scoring.
Microbiome composition
Time frame: through study completion, an average of 1 year
Collection of skin culture samples from body regions surrounding the RT treatment area and a control area
1 secondary outcome
Validation Procedure of evaluation of Radiation Dermatitis grade by the our application (Radia-App)
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2021.
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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.
Roxolyana Abdah-Borthnyak, MD principal investigator
Director, Radiation Service for Female Cancer
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 Radiation Dermatitis, run by AceTech at 1 site in Israel.
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 7 inclusion and 11 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 21 Jul 2021. 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 Israel. 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?
Radiation Dermatitis grade (time frame: through study completion, an average of 1 year). 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 21 Jul 2021.