DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Patients Overexposed for a Prostate Adenocarcinoma

Information source: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Prostate Adenocarcinoma

Intervention: Whole blood sample (Other)

Phase: N/A

Status: Completed

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

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: Observational Model: Case-Only, Time Perspective: 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

Groupe Hospitalier Pitié-Salpêtrière, Paris 75013, France
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
Last updated: February 26, 2014

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017