Merkel CarcinomaPAESCARTNCT03060226
Prediction of Appearance of Late Cutaneous Side Effects After RadioTherapy
A study testing blood sample in people with Merkel Carcinoma and Radiotherapy Side Effect, run by Centre Francois Baclesse at 1 site in France.
Trial summary
Search for blood predictive marker (s) for cutaneous radiosensitivity Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Merkel Carcinoma, Radiotherapy Side Effect
- What is being tested?
- blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- 9 Feb 2017to 20 Dec 2018
- Phase
- Interventional
- 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
Who may be able to join
- Patient treated with surgery and radiotherapy (RT) for histologically proven Merkel carcinoma
- Previous radiotherapy treatment completed for at least 6 months
- Absence of prior treatment by chemotherapy or hormonotherapy
- Patient over 18 years of age
- Patient affiliated to a social security system
- Informed consent signed
Who cannot join
- Presence of another evolutionary cancer
- Re-irradiation in the same area
- Absence of available dosimetry data
- Patient under guardianship or curatorship or safeguard of justice
Trial locations and contacts
1 site in 1 country.
About this study
Search for blood predictive marker (s) for cutaneous radiosensitivity
- Conditions
- Merkel Carcinoma, Radiotherapy Side Effect
- Being tested
- blood sample
- Medical subject headings
- Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampleDiagnostic test
Search of blood predictive marker (s)
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | Not described Receives: Diagnostic Test: blood sample |
| radiosensibility group | Other | Not described Receives: Diagnostic Test: blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification and dosage of blood predictive marker(s)
Concentration of IL-1α, IL-1β, IL-4, IL-6, IL-8, IL-10, TNF-α, TGF-β, IL-13, IL-17 and CRP
Measured: 1 blood sample at inclusion
Identification and dosage of blood predictive marker(s)
Concentration of 8-OHdG extracellular, Antioxidant enzymes (catalase, superoxyde dismutase, glutathion peroxydase)
Measured: 1 blood sample at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start9 Feb 2017
- Primary completion20 Dec 2018
- Study completion20 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Merkel 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03060226
- Sponsor's protocol ID
- 2016-A02021-50
- Acronym
- PAESCART
- Status last verified
- Dec 2018
- First submitted
- 14 Feb 2017
- Last updated
- 21 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Appearance of Late Cutaneous Side Effects After RadioTherapy
- ClinicalTrials.gov ID
- NCT03060226
- Acronym / sponsor ID
- PAESCART / 2016-A02021-50
- Conditions
- Merkel Carcinoma, Radiotherapy Side Effect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Centre Francois BaclesseUniversity, hospital or other
- Study start
- 9 Feb 2017 (actual)
- Primary completion
- 20 Dec 2018 (actual)
- Study completion
- 20 Dec 2018 (actual)
- First posted
- 23 Feb 2017 (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.
Search for blood predictive marker (s) for cutaneous radiosensitivity
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Diagnostic Test: blood sample |
| radiosensibility group | Other | Diagnostic Test: blood sample |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient treated with surgery and radiotherapy (RT) for histologically proven Merkel carcinoma
- Previous radiotherapy treatment completed for at least 6 months
- Absence of prior treatment by chemotherapy or hormonotherapy
- Patient over 18 years of age
- Patient affiliated to a social security system
Key exclusion criteria (4 listed)
- Presence of another evolutionary cancer
- Re-irradiation in the same area
- Absence of available dosimetry data
- Patient under guardianship or curatorship or safeguard of justice
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 |
|---|---|---|
| blood sampleSearch of blood predictive marker (s) | Diagnostic test | Control group, radiosensibility group |
Primary outcome
Identification and dosage of blood predictive marker(s)
Time frame: 1 blood sample at inclusion
Concentration of IL-1α, IL-1β, IL-4, IL-6, IL-8, IL-10, TNF-α, TGF-β, IL-13, IL-17 and CRP
Identification and dosage of blood predictive marker(s)
Time frame: 1 blood sample at inclusion
Concentration of 8-OHdG extracellular, Antioxidant enzymes (catalase, superoxyde dismutase, glutathion peroxydase)
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 21 Dec 2018.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood sample in people with Merkel Carcinoma and Radiotherapy Side Effect, run by Centre Francois Baclesse at 1 site in France.
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 4 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 21 Dec 2018. 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 France. 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?
Identification and dosage of blood predictive marker(s) (time frame: 1 blood sample at inclusion). 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 Dec 2018.