Collecting and Storing Tissue Samples From Women With or Without Breast Cancer (NCT00899301) | Clinical Trial Compass
RecruitingNot Applicable
Collecting and Storing Tissue Samples From Women With or Without Breast Cancer
United States4,000 participantsStarted 2004-01-22
Plain-language summary
RATIONALE: Collecting and storing samples of tissue, blood, and urine from patients with or without breast cancer to study in the laboratory may help the study of cancer.
PURPOSE: This research study is collecting and storing tissue samples from women with or without breast cancer.
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.
* Breast lesion which is suspected to be cancer or a known diagnosis of breast cancer (any stage, at any point in the disease trajectory) who agrees to donate tissue/body fluids.
* Individuals of all races and ethnic groups are eligible for this trial. There is no restriction regarding age, race, or ethnicity. The trial is open to the accrual of men and women.
* Must sign informed consent for study of tumor specimens as part of a research project.
* Must give permission for their tumor specimens to be obtained from outside institutions for molecular analyses.
* Must be willing to be followed for recurrence, relapse and death from disease.
ELIGIBILITY CRITERIA FOR OPTIONAL PHYSICAL FUNCTION AND COGNITIVE ASSESSMENTS
* Must be 60 years of age or older
* Have completed initial round of cancer treatment
* Have completed the optional online survey and opted-in for the physical function and cognitive assessments
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
Creation of a tissue repository that contains DNA, RNA, or protein from tumor tissue or normal tissue, peripheral blood lymphocytes, and plasma that are linked to frozen and/or paraffin-embedded pathology specimens