RadiotherapyPROUSTNCT04253288
Prospective Registration of mOrbidity and Mortality, individUal radioSensitivity and Radiation Technique (PROUST)
A study testing Morbidity Mortality Review (MMR) in people with Radiotherapy, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
Background: Recently, an increasing international interest has arisen in using morbidity and mortality rates to monitor the quality of hospital cares (1, 2). Many hospitals have integrated the morbidity and mortality review (MMR) meetings into their governance processes, by making them mandatory and more accountable… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiotherapy
- What is being tested?
- Morbidity Mortality Review (MMR)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Feb 2020to Feb 2025
- 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
- Age ≥ 18 years
- Patients who received RT alone or associated to other anti-cancer treatments
- Significant and durable toxicity grade > 3 whatever the organs concerned by radiation exposure
- Completion of baseline clinical and dosimetric data collection
- Patients with no psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- Signed informed consent to participate in the study must be obtained from patients after they have been fully informed on the nature and interest to investigated radiosensitivity by the investigator.
Who cannot join
- No formal MMR meeting in the center where the patient has been treated
- No clinical and/or dosimetric available data
- No quality of life questionnaire completion whatever the cause
- Patients who do not agree to have at least one of the planed biologic tests, namely, skin biopsy and blood samples.
- Absence of affiliation to National French social security system
- Patient deprived of freedom or under legal protection (guardianship,curatorship)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The French Registry Of Morbidity And Mortality Reviews (MMR) Meetings: Prospective Registration Of Clinical, Dosimetric And Individual Biological Radiosensitivity Data Of Patients With Severe Radiation Toxicity (PROUST STUDY)
Background: Recently, an increasing international interest has arisen in using morbidity and mortality rates to monitor the quality of hospital cares (1, 2). Many hospitals have integrated the morbidity and mortality review (MMR) meetings into their governance processes, by making them mandatory and more accountable for taking corrective action (3-5).
Quality of radiotherapy (RT) delivery is highly operator dependent. The operator is a team of professionals including radiation oncologists, planning dosimetrists, physicists and technicians. Because of this complex, multi-step process, there is margin for error, which may affect outcomes and toxicity. Some deviations may have minimal effects on outcome, while others may have a profound effect and compromise long-term results. For the morbidity after RT, MMR is identified as one of the most adapted process to highlight whether and how these meetings provide assurance within the organizations' governance processes in radiation departments.
Read more
In France, many teams have not reached a formalized procedure for a systematic MMR. Furthermore, implementation of MMR in RT departments is very heterogeneous and not always meets the criteria defined by the Health Authorities (HAS) (6).
Systemic analysis conducted during the MMR is a comprehensive analysis of the situation, taking into account all technical and human elements. The diagnosis and type of morbidity depends on the irradiated volume, the dose delivered to the organ at risk and the individual radiosensitivity.
Follow-up after RT is important to evaluate outcome results and late toxicity. In general, late effects consist of tissue fibrosis and vascular damage, which can result in cosmetic and functional deterioration. Some of the radiation-induced sequelea may require particular management including hospitalization (lung fibrosis, gastro-intestinal and genito-urinary toxicities,..), while for other ones, only local treatments are needed (mucosal toxicity, skin fibrosis…). The challenge for clinicians in the frame of the MMR is to make sure that there is no controversy about the delivered RT quality and investigate other potential causes such as particular intrinsic radiosensitivity of the patient for a given standard treatment.
Read the detailed description
The study consist of a prospective registration in a dedicated database (PROUST) of severe radiation toxicity that aims to implement MMR procedure in the French radiotherapy departments.
- Conditions
- Radiotherapy
- Being tested
- Morbidity Mortality Review (MMR)
- Keywords
- MMR, Radiation toxicity, Radiosensitivity, Late effects
- Medical subject headings
- Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Morbidity Mortality Review (MMR)Other
Also called National database from MMR
- Standardization of Morbidity Mortality Review (MMR) in radiotherapy centers
- National database from MMR board meetings which include clinical , radiation technique and biological parameters of intrinsic radiosensitivity of patients
| Study group | Role | What they receive |
|---|---|---|
| Patients with severe radiation toxicity | Other | Patients who received radiotherapy and developed abnormal radiation-induced toxicity Receives: Other: Morbidity Mortality Review (MMR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Database of MMR boards
The PROUST national database of MMR boards, will be an opportunity to structure data collection on severe and durable radiation toxicity with an objective evaluation taking into account individual radiosensitivity.
Measured: at 3 Months
Database of MMR boards
The PROUST national database of MMR boards, will be an opportunity to structure data collection on severe and durable radiation toxicity with an objective evaluation taking into account individual radiosensitivity.
Measured: at 6 Months
Database of MMR boards
The PROUST national database of MMR boards, will be an opportunity to structure data collection on severe and durable radiation toxicity with an objective evaluation taking into account individual radiosensitivity.
Measured: at 9 Months
Database of MMR boards
The PROUST national database of MMR boards, will be an opportunity to structure data collection on severe and durable radiation toxicity with an objective evaluation taking into account individual radiosensitivity.
Measured: at 12 Months
Database of MMR boards
The PROUST national database of MMR boards, will be an opportunity to structure data collection on severe and durable radiation toxicity with an objective evaluation taking into account individual radiosensitivity.
Measured: at 24 Months
Secondary outcomes (4)
Radiation toxicity
The rating scale NCI/CTCAE v4.03 will be used to differentiate between major and minor complications. Only major complications (grade > 3) will be included in the database.
Measured: at Day 0
Associated treatments to radiation
All drugs used either administered concurrently or sequentially with RT will be recorded
Measured: at Day 0, 3 Months, 6 Months, 9 Months,12 Months, 15 Months, 18 Months, 21 Months and 24 Months
Follow-up and management strategy
Patients included in the database will have a planned follow-up every 3 to 6 months after inclusion during at least 2 years.The follow-up will be adjusted according to institution policy of the oncologic follow-up in case of regression of the clinical symptoms of toxicity.
Measured: at Day 0, 3 Months, 6 Months, 9 Months,12 Months, 15 Months, 18 Months, 21 Months and 24 Months
Evolution of life's quality
The evaluation of the quality of life will be conducted using the Short-Form 36 questionnaire. This generic scale contains 36 items divided into eight dimensions, each corresponding to a different aspect of health and for a comprehensive assessment of the quality of life.
Measured: at Day 0, 3 Months, 6 Months, 9 Months,12 Months, 15 Months, 18 Months, 21 Months and 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study startFeb 2020 (estimated)
- Primary completionFeb 2025 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RadiotherapyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yazid BELKACEMI, MD, PhD, Principal investigator, Assistance Publique Hôpitaux de Paris (AP-HP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04253288
- Sponsor's protocol ID
- K160101J
- Acronym
- PROUST
- Status last verified
- Nov 2019
- First submitted
- 6 Jan 2020
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Datas are own by Assistance Publique - Hôpitaux de Paris, please contact sponsor for further information
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The French Registry Of Morbidity And Mortality Reviews (MMR) Meetings: Prospective Registration Of Clinical, Dosimetric And Individual Biological Radiosensitivity Data Of Patients With Severe Radiation Toxicity (PROUST STUDY)
- ClinicalTrials.gov ID
- NCT04253288
- Acronym / sponsor ID
- PROUST / K160101J
- Conditions
- Radiotherapy
- Keywords
- MMR, Radiation toxicity, Radiosensitivity, Late effects
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Feb 2020 (estimated)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 5 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.
Background: Recently, an increasing international interest has arisen in using morbidity and mortality rates to monitor the quality of hospital cares (1, 2). Many hospitals have integrated the morbidity and mortality review (MMR) meetings into their governance processes, by making them mandatory and more accountable for taking corrective action (3-5).
Quality of radiotherapy (RT) delivery is highly operator dependent. The operator is a team of professionals including radiation oncologists, planning dosimetrists, physicists and technicians. Because of this complex, multi-step process, there is margin for error, which may affect outcomes and toxicity. Some deviations may have minimal effects on outcome, while others may have a profound effect and compromise long-term results. For the morbidity after RT, MMR is identified as one of the most adapted process to highlight whether and how these meetings provide assurance within the organizations' governance processes in radiation departments.
In France, many teams have not reached a formalized procedure for a systematic MMR. Furthermore, implementation of MMR in RT departments is very heterogeneous and not always meets the criteria defined by the Health Authorities (HAS) (6).
Systemic analysis conducted during the MMR is a comprehensive analysis of the situation, taking into account all technical and human elements. The diagnosis and type of morbidity depends on the irradiated volume, the dose delivered to the organ at risk and the individual radiosensitivity.
Follow-up after RT is important to evaluate outcome results and late toxicity. In general, late effects consist of tissue fibrosis and vascular damage, which can result in cosmetic and functional deterioration. Some of the radiation-induced sequelea may require particular management including hospitalization (lung fibrosis, gastro-intestinal and genito-urinary toxicities,..), while for other ones, only local treatments are needed (mucosal toxicity, skin fibrosis…). The challenge for clinicians in the frame of the MMR is to make sure that there is no controversy about the delivered RT quality and investigate other potential causes such as particular intrinsic radiosensitivity of the patient for a given standard treatment.
Detailed description
The study consist of a prospective registration in a dedicated database (PROUST) of severe radiation toxicity that aims to implement MMR procedure in the French radiotherapy departments.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with severe radiation toxicity | Other | Other: Morbidity Mortality Review (MMR)Patients who received radiotherapy and developed abnormal radiation-induced toxicity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years
- Patients who received RT alone or associated to other anti-cancer treatments
- Significant and durable toxicity grade > 3 whatever the organs concerned by radiation exposure
- Completion of baseline clinical and dosimetric data collection
- Patients with no psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Key exclusion criteria (6 listed)
- No formal MMR meeting in the center where the patient has been treated
- No clinical and/or dosimetric available data
- No quality of life questionnaire completion whatever the cause
- Patients who do not agree to have at least one of the planed biologic tests, namely, skin biopsy and blood samples.
- Absence of affiliation to National French social security system
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 |
|---|---|---|
| Morbidity Mortality Review (MMR)Also: National database from MMR* Standardization of Morbidity Mortality Review (MMR) in radiotherapy centers * National database from MMR board meetings which include clinical , radiation technique and biological parameters of intrinsic radiosensitivity of patients | Other | Patients with severe radiation toxicity |
Primary outcome
Database of MMR boards
Time frame: at 3 Months
The PROUST national database of MMR boards, will be an opportunity to structure data collection on severe and durable radiation toxicity with an objective evaluation taking into account individual radiosensitivity.
Database of MMR boards
Time frame: at 6 Months
The PROUST national database of MMR boards, will be an opportunity to structure data collection on severe and durable radiation toxicity with an objective evaluation taking into account individual radiosensitivity.
Database of MMR boards
Time frame: at 9 Months
The PROUST national database of MMR boards, will be an opportunity to structure data collection on severe and durable radiation toxicity with an objective evaluation taking into account individual radiosensitivity.
Database of MMR boards
Time frame: at 12 Months
The PROUST national database of MMR boards, will be an opportunity to structure data collection on severe and durable radiation toxicity with an objective evaluation taking into account individual radiosensitivity.
Database of MMR boards
Time frame: at 24 Months
The PROUST national database of MMR boards, will be an opportunity to structure data collection on severe and durable radiation toxicity with an objective evaluation taking into account individual radiosensitivity.
4 secondary outcomes
Radiation toxicity
Time frame: at Day 0
Associated treatments to radiation
Time frame: at Day 0, 3 Months, 6 Months, 9 Months,12 Months, 15 Months, 18 Months, 21 Months and 24 Months
Follow-up and management strategy
Time frame: at Day 0, 3 Months, 6 Months, 9 Months,12 Months, 15 Months, 18 Months, 21 Months and 24 Months
Evolution of life's quality
Time frame: at Day 0, 3 Months, 6 Months, 9 Months,12 Months, 15 Months, 18 Months, 21 Months and 24 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Individual participant dataSharing planned: No. Datas are own by Assistance Publique - Hôpitaux de Paris, please contact sponsor for further information
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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.
Yazid BELKACEMI, MD, PhD principal investigator
Assistance Publique Hôpitaux de Paris (AP-HP)
Questions about this trial
What is this clinical trial studying?
A study testing Morbidity Mortality Review (MMR) in people with Radiotherapy, run by Assistance Publique - Hôpitaux de Paris.
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 6 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 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Yazid BELKACEMI, MD, PhD ((0)149814522 ext. + 33, yazid.belkacemi@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Database of MMR boards (time frame: at 3 Months). The study lists 5 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 Feb 2020.