Patients Overexposed for a Prostate Adenocarcinoma
Information source: Assistance Publique - Hôpitaux de Paris
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Prostate Adenocarcinoma
Intervention: Whole blood sample (Other)
Phase: N/A
Status: Recruiting
Sponsored by: Assistance Publique - Hôpitaux de Paris Official(s) and/or principal investigator(s):
Jean Marc SIMON, PH, Principal Investigator, Affiliation: Assistance Publique - Hôpitaux de Paris
Overall contact:
Jean-Marc SIMON, MD, Phone: 33 (0) 1 42 17 81 74, Email: jean-marc.simon@psl.aphp.fr
Summary
Background:
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).
Clinical Details
Official title: Surveillance of the Cohort of Patients Overexposed in a Course of Conformational Radiotherapy for a Prostate Adenocarcinoma in Jean MONNET Hospital, Epinal, France. Epinal: Patients Overexposed for a Prostate Adenocarcinoma
Study design: Case-Only, Cross-Sectional
Primary outcome: To correlate the received doses, the volume of irradiated normal tissues, the events, with biologic, phenotypic and genetic data.
Secondary outcome: 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
Detailed description:
Secondary study endpoint:
- 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- provision of informed consent
- 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:
- No provision of informed consent
- Patient with disease worsening and in incapacity to move about to CHJM
Locations and Contacts
Jean-Marc SIMON, MD, Phone: 33 (0) 1 42 17 81 74, Email: jean-marc.simon@psl.aphp.fr
Groupe Hospitalier Pitié-Salpêtrière, Paris 75013, France; Recruiting
Jean-marc Simon, MD, Phone: 33 (0) 1 42 17 81 74, Email: jean-marc.simon@psl.aphp.fr
Additional Information
Related publications: 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. Epub 2007 Feb 27.
Starting date: October 2008
Ending date: April 2010
Last updated: April 1, 2009
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