Identification of Breast Cancer Specific Markers in Patients Compared to Healthy Participants (NCT05054010) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Identification of Breast Cancer Specific Markers in Patients Compared to Healthy Participants
Italy84 participantsStarted 2021-10-04
Plain-language summary
This is an exploratory research study with the aim of identifying specific cancer biomarkers in various subtypes of breast cancer. Blood samples will be collected from 60 participants divided into 40 patients and 20 healthy donors. An amendment to the research has been proposed to enroll 24 additional participants divided into 12 patients and 12 healthy donors.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participant is willing and able to give and sign a written informed consent for participation in the study.
* Female aged 18 years or above.
* Diagnosed with early breast cancer (stage I and II) or metastatic breast cancer.
* Healthy participants who visit the site for reason other than cancer diagnosis (including breast cancer).
Exclusion Criteria:
* History of other malignancies other than breast cancer (for healthy participants includes also breast cancer).
* Undergone surgery or treatment for breast cancer before enrollment (only for early breast cancer).
* Presence of known severe coagulation or haematological disorder
* Known Pregnancy
* Absence of written signed informed consent for participation in the study
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of commercial Antibodies capable of Identify specific Breast Cancer Biomarkers