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Prospective Registration of mOrbidity and Mortality, individUal radioSensitivity and Radiation Technique (PROUST) (PROUST)

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ClinicalTrials.gov Identifier: NCT04253288
Recruitment Status : Not yet recruiting
First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE January 6, 2020
First Posted Date  ICMJE February 5, 2020
Last Update Posted Date February 5, 2020
Estimated Study Start Date  ICMJE February 2020
Estimated Primary Completion Date February 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2020)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2020)
  • Radiation toxicity [ Time Frame: at Day 0 ]
    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.
  • 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 ]
    All drugs used either administered concurrently or sequentially with RT will be recorded
  • 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 ]
    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.
  • 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 ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prospective Registration of mOrbidity and Mortality, individUal radioSensitivity and Radiation Technique (PROUST)
Official Title  ICMJE 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)
Brief 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 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Radiotherapy
Intervention  ICMJE Other: Morbidity Mortality Review (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 Name: National database from MMR
Study Arms  ICMJE Patients with severe radiation toxicity
Patients who received radiotherapy and developed abnormal radiation-induced toxicity
Intervention: Other: Morbidity Mortality Review (MMR)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: January 31, 2020)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2025
Estimated Primary Completion Date February 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Yazid BELKACEMI, MD, PhD (0)149814522 ext + 33 yazid.belkacemi@aphp.fr
Contact: David SCHMITZ (0) 1 49 81 36 24 ext + 33 david.schmitz@aphp.fr
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04253288
Other Study ID Numbers  ICMJE K160101J
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Datas are own by Assistance Publique - Hôpitaux de Paris, please contact sponsor for further information
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yazid BELKACEMI, MD, PhD Assistance Publique Hôpitaux de Paris (AP-HP)
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP