Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:38 PM
Ignite Modification Date:
2025-12-24 @ 10:38 PM
NCT ID:
NCT00893035
Eligibility Criteria:
Inclusion Criteria for prostate cancer patients:
* localised prostate cancer, histologically proven
* Absence of metastases (M0) : normal bone scintigraphy
* Absence of radiological lymph node invasion (N0).
* Clinical Stage : T ≥ T1c-T2a and \< T3b Or T1b or c with PSA ≤ 10 ng/ml . Or T1b or c with Gleason ≥ 6
* PSA \< 30 ng/ml.
* Signs and symptoms according to NCI/CTC v3.0 \< grade 2
* ECOG Performance status ≤ 1
* Absence of hip prothesis
* Absence de endopenian stent
* Patient aged \> 18 and \< 80
* Patient affiliated with social security
* Written informed consent, dated and signed
Exclusion Criteria for prostate cancer patients:
* Antecedents of invasive cancer (unless if treated more than 5 years ago without evolution) except basocellular carcinoma
* positive biopsy of seminal vesicle
* PSA ≥ 30 ng/ml for two successive dosages
* Previous pelvic irradiation
* Previous radical prostatectomy for cancer
* Patients with another systemic disease (cardiovascular, renal, hepatic, pulmonary embolism, etc.) non stabilised or generalised sclerodermitis.
* Patients known to be HIV seropositive (no specific test is necessary for defining eligibility)
* Known homozygote ATM (Ataxy telangiectasy) mutation
* Impossibility for a correct follow up (for social family or geographical reasons)
* Patients incapable of providing consent, protected majors, vulnerable persons
* Patients participating in other clinical trials
Inclusion Criteria for breast cancer patients:
* Breast Conservative surgery
* Non metastatic, M0
* negative surgical margins
* T1, T2; negative sentinel lymph node N0, N1 or N2.
* Signs and symptoms according to NCI/CTC v3.0 \< grade 2
* Patient aged over 18 years and less than 60 or more than 60 with an indication for boost irradiation.
* Patient affiliated with social security
* Written informed consent, dated and signed
Exclusion Criteria for breast cancer patients:
* Metastatic patients
* Bilateral breast cancer (concomitant or previous) except in situ
* T4 or N3 or treated by mastectomy
* Patients with chemotherapy or neoadjuvant hormonotherapy
* Patients with a previous other cancer within the last 5 years EXCEPT basocellular carcinoma of the skin or in situ cancer of the uterus.
* Patients with another systemic disease (cardiovascular, renal, hepatic, pulmonary embolism, etc.) non stabilised or generalised sclerodermia.
* Pregnant or breast feeding women
* Patients known to be HIV seropositive (no specific test is necessary for defining eligibility)
* Known homozygote ATM (Ataxy telangiectasy) mutation
* Impossibility for a correct follow up (for social family or geographical reasons)
* Patients incapable of providing consent, protected majors, vulnerable persons
* Patients participating in other clinical trials
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00893035
Study Brief:
Protocol Section:
NCT00893035