Identification and Characterization of Commercial RUO Antibodies for the Detection of Specific Prostate Cancer Tumoral Markers Expressed in Potential Circulating Tumoral Cells (CTCs)
概览
- 阶段
- 不适用
- 干预措施
- Healthy donor
- 疾病 / 适应症
- Prostatic Neoplasms
- 发起方
- Tethis S.p.A.
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number of commercial Antibodies capable of identify specific Prostate Cancer Biomarkers
- 状态
- 进行中（未招募）
- 最后更新
- 2个月前
概览
简要总结
This is an exploratory research study with the aim of identifying specific cancer biomarkers in various subtypes of prostate cancer. Blood samples will be collected from 60 participants divided into 40 patients and 20 healthy donors.
详细描述
In this research study different commercial RUO (Research Use Only) antibodies will be purchased and then tested on blood samples obtained by patients affected by prostate cancer and by healthy participants as control. Sixty participants will be enrolled belonging to different risk categories:20 participants affected by prostate cancer at low risk, 20 participants affected by prostate cancer at high risk, and 20 participants without a cancer disease (healthy volunteers) as control. Risk categorization is based on the definition of the European Association of Urology. After signing the informed consent form, participants will be screened to evaluate if they meet the eligibility criteria. If all the criteria are met, participants will be enrolled into the study and will be asked to provide some demographic and other data. A 13 ml blood sample will be collected by the participants and shipped to Sponsor's laboratories, in order to be processed and analysed.
研究者
入排标准
入选标准
- •Participant is willing and able to give and sign a written informed consent for participation in the study
- •Male, aged 18 years or above
- •Diagnosed with prostate cancer at low or high risk
- •Candidate to active surveillance (in case of low-risk disease) or treatment with curative intent such as radical prostatectomy or radiation therapy (in case of low risk patients not willing to undergo active surveillance or patients with high risk disease)
- •Healthy participants undergoing a visit at the site for reason other than cancer diagnosis (including prostate cancer)
排除标准
- •History of other malignancies other than prostate cancer (for healthy participants includes also prostate cancer)
- •Undergone surgery or treatment for prostate cancer before enrolment
- •Presence of known severe coagulation or haematological disorder
- •Absence of written signed informed consent for participation in the study
研究组 & 干预措施
Healthy donor
Participants who are in good health and without history of cancer disease.
Low risk prostate cancer patients
Prostate cancer risk category is based on the definition of the European Association of Urology, namely low risk (PSA (prostate-specific antigen) \<10 ng/ml, and stage T1/T2a and Gleason score 3+3).
High risk prostate cancer patients
Prostate cancer risk category is based on the definition of the European Association of Urology, namely high risk (PSA (prostate-specific antigen) \>20 ng/ml or stage T3 or higher or biopsy Gleason score 8-10).
结局指标
主要结局
Number of commercial Antibodies capable of identify specific Prostate Cancer Biomarkers
时间窗: day 1 : blood collection day
Qualitative assessment of Staining Positivity for different Prostate Cancer Biomarkers