Prostate AdenocarcinomaEPOPANCT00773656
Patients Overexposed for a Prostate Adenocarcinoma
An observational study of Prostate Adenocarcinoma, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Adenocarcinoma
- What is being tested?
- Whole blood sample
- How many people
- 249 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2008to May 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients treated for a prostate adenocarcinoma in the radiation department of the Jean MONNET Hospital between 2000 and 2006.
Who may be able to join
- 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
Who cannot join
- No provision of informed consent
- Patient with disease worsening and in incapacity to move about to CHJM
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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).
Read the 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.
- Conditions
- Prostate Adenocarcinoma
- Being tested
- Whole blood sample
- Keywords
- Radiotherapy, Biologically effective dose, Radiation injury
- Medical subject headings
- Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole blood sampleOther
70 ml per patient for collection of biological sample
| Study group | Role | What they receive |
|---|---|---|
| 1 | patients treated for a prostate adenocarcinoma Receives: Other: Whole blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
To correlate the received doses, the volume of irradiated normal tissues, the events, with biologic, phenotypic and genetic data.
Measured: At the inclusion visit
Secondary outcomes (4)
Correlation between adverse events and radiation doses with biologic, phenotypic and genetic data.
Measured: At the inclusion visit
Evaluation of T-lymphocyte apoptosis to predict radiation-induced late toxicity
Measured: At the inclusion visit
Gene associations with risks for adverse events related to radiotherapy
Measured: At the inclusion visit
Levels of circulating microparticles and bystander effect after irradiation
Measured: At the inclusion visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prostate AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 249 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Marc SIMON, PH, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00773656
- Sponsor's protocol ID
- AOM 08234
- Acronym
- EPOPA
- Status last verified
- Feb 2014
- First submitted
- 15 Oct 2008
- Last updated
- 27 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
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. doi: 10.1016/j.ijrobp.2006.12.050. Epub 2007 Feb 27.
PubMed 17331670Ribault 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.
PubMed 36739457
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00773656
- Acronym / sponsor ID
- EPOPA / AOM 08234
- Conditions
- Prostate Adenocarcinoma
- Keywords
- Radiotherapy, Biologically effective dose, Radiation injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 249 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 16 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: Whole blood samplepatients treated for a prostate adenocarcinoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients treated for a prostate adenocarcinoma in the radiation department of the Jean MONNET Hospital between 2000 and 2006.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- No provision of informed consent
- Patient with disease worsening and in incapacity to move about to CHJM
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole blood sample70 ml per patient for collection of biological sample | Other | 1 |
Primary outcome
To correlate the received doses, the volume of irradiated normal tissues, the events, with biologic, phenotypic and genetic data.
Time frame: At the inclusion visit
4 secondary outcomes
Correlation between adverse events and radiation doses with biologic, phenotypic and genetic data.
Time frame: At the inclusion visit
Evaluation of T-lymphocyte apoptosis to predict radiation-induced late toxicity
Time frame: At the inclusion visit
Gene associations with risks for adverse events related to radiotherapy
Time frame: At the inclusion visit
Levels of circulating microparticles and bystander effect after irradiation
Time frame: At the inclusion visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2014.
- Background: PubMed 17331670Alsbeih 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.
- Derived from this study: PubMed 36739457Ribault 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Marc SIMON, PH principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Adenocarcinoma, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To correlate the received doses, the volume of irradiated normal tissues, the events, with biologic, phenotypic and genetic data. (time frame: At the inclusion visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00773656, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2014.