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

NCT04253288 | Unknown

• 1 other identifier: K160101J
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Radiotherapy

Keywords

MMR; Radiation toxicity; Radiosensitivity; Late effects

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  at 24 Months

Secondary Outcomes (4)

• Radiation toxicity

  at Day 0

• Associated treatments to radiation

  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

  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

  at Day 0, 3 Months, 6 Months, 9 Months,12 Months, 15 Months, 18 Months, 21 Months and 24 Months

Study Arms (1)

Patients with severe radiation toxicity

OTHER

Patients who received radiotherapy and developed abnormal radiation-induced toxicity

Other: Morbidity Mortality Review (MMR)

Interventions

Morbidity Mortality Review (MMR) OTHER

* 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

Also known as: National database from MMR

Patients with severe radiation toxicity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

MeSH Terms

Conditions

Radiation Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Yazid BELKACEMI, MD, PhD

  Assistance Publique Hôpitaux de Paris (AP-HP)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yazid BELKACEMI, MD, PhD

CONTACT

(0)149814522; yazid.belkacemi@aphp.fr

David SCHMITZ

CONTACT

(0) 1 49 81 36 24; david.schmitz@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2020
• First Posted: February 5, 2020
• Study Start: February 1, 2020
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: February 5, 2020

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share