Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
249 participants
OBSERVATIONAL
2008-10-31
2013-05-31
Brief Summary
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Between 2000 and 2006, 433 patients were overexposed (8% to 10%) during a course of conformal radiotherapy for a prostate adenocarcinoma in Jean MONNET hospital, Epinal, France. Among them, twenty four patients received an additional mean dose about 20%, due to an inappropriate use of the treatment planning system. Severe adverse events (proctitis, cystitis, and tissue necrosis) have occurred among most of these overexposed patients. We propose to develop several research programs in order to increase the scientific knowledge on iatrogenic effects related to overexposure of ionizing radiation, by studying their relationship with dosimetric, clinical, biologic and genetic characteristics.
Aim of the study:
To correlate the received doses, the volume of irradiated normal tissues, the events, with biologic, phenotypic and genetic data.
Primary study endpoint:
Incidence and severity of adverse events related to radiotherapy (according to SOMA - LENT and CTCAE scales).
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Detailed Description
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* Correlation between adverse events and radiation doses with biologic, phenotypic and genetic data.
* Evaluation of T-lymphocyte apoptosis to predict radiation-induced late toxicity
* Gene associations with risks for adverse events related to radiotherapy
* Levels of circulating microparticles and bystander effect after irradiation
Inclusion criteria:
Consecutive patients treated for a prostate adenocarcinoma in the radiation department of the Jean MONNET Hospital between 2000 and 2006.
Potential. Better identification of patients at high risk of adverse events related to radiotherapy.
Conditions
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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Study Groups
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1
patients treated for a prostate adenocarcinoma
Whole blood sample
70 ml per patient for collection of biological sample
Interventions
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Whole blood sample
70 ml per patient for collection of biological sample
Eligibility Criteria
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Inclusion Criteria
* patient treated for prostate adenocarcinoma and overexposed during radiotherapy in a prostate adenocarcinoma in the radiation department of the a prostate adenocarcinoma in the radiation department of the Jean MONNET hospital/ service de radiotherapies between 2000 and 2006
Exclusion Criteria
* Patient with disease worsening and in incapacity to move about to CHJM
18 Years
MALE
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Jean Marc SIMON, PH
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
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Groupe Hospitalier Pitié-Salpêtrière
Paris, , France
Countries
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References
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Alsbeih G, El-Sebaie M, Al-Harbi N, Al-Buhairi M, Al-Hadyan K, Al-Rajhi N. Radiosensitivity of human fibroblasts is associated with amino acid substitution variants in susceptible genes and correlates with the number of risk alleles. Int J Radiat Oncol Biol Phys. 2007 May 1;68(1):229-35. doi: 10.1016/j.ijrobp.2006.12.050. Epub 2007 Feb 27.
Ribault A, Benadjaoud MA, Squiban C, Arnaud L, Judicone C, Leroyer AS, Rousseau A, Huet C, Guha C, Benderitter M, Lacroix R, Flamant S, Chen EI, Simon JM, Tamarat R. Circulating microvesicles correlate with radiation proctitis complication after radiotherapy. Sci Rep. 2023 Feb 4;13(1):2033. doi: 10.1038/s41598-022-21726-y.
Other Identifiers
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AOM 08234
Identifier Type: -
Identifier Source: org_study_id
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