Patients Overexposed for a Prostate Adenocarcinoma

NCT00773656 | Completed DMC

• 1 other identifier: AOM 08234
• Study Type: observational
• Target: 249
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Prostate Adenocarcinoma

Keywords

Radiotherapy; Biologically effective dose; Radiation injury

Outcome Measures

Primary Outcomes (1)

• To correlate the received doses, the volume of irradiated normal tissues, the events, with biologic, phenotypic and genetic data.

  At the inclusion visit

Secondary Outcomes (4)

• Correlation between adverse events and radiation doses with biologic, phenotypic and genetic data.

  At the inclusion visit

• Evaluation of T-lymphocyte apoptosis to predict radiation-induced late toxicity

  At the inclusion visit

• Gene associations with risks for adverse events related to radiotherapy

  At the inclusion visit

• Levels of circulating microparticles and bystander effect after irradiation

  At the inclusion visit

Study Arms (1)

1

patients treated for a prostate adenocarcinoma

Other: Whole blood sample

Interventions

Whole blood sample OTHER

70 ml per patient for collection of biological sample

1

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients treated for a prostate adenocarcinoma in the radiation department of the Jean MONNET Hospital between 2000 and 2006.

You may qualify if:

• 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

You may not qualify if:

• No provision of informed consent
• Patient with disease worsening and in incapacity to move about to CHJM

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Groupe Hospitalier Pitié-Salpêtrière

Paris, 75013, France

Location

Related Publications (2)

• 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.

  PMID: 17331670 BACKGROUND

• 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.

  PMID: 36739457 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

White cells, serum and DNA

MeSH Terms

Conditions

Radiation Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Jean Marc SIMON, PH

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2008
• First Posted: October 16, 2008
• Study Start: October 1, 2008
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: February 27, 2014

Record last verified: 2014-02

Locations

FR (1)