Studying Blood and Tumor Tissue Samples in Women With Invasive Breast Cancer, Ductal or Lobular C… (NCT00898508) | Clinical Trial Compass
CompletedNot Applicable
Studying Blood and Tumor Tissue Samples in Women With Invasive Breast Cancer, Ductal or Lobular Carcinoma in Situ, or Benign Breast Disease
United States563 participantsStarted 2005-08
Plain-language summary
RATIONALE: Collecting and storing samples of blood and tumor tissue from patients with cancer to test in the laboratory may help the study of cancer in the future.
PURPOSE: This clinical trial is studying blood and tumor tissue samples in women with invasive breast cancer, ductal carcinoma in situ, lobular carcinoma in situ, or benign breast disease.
Who can participate
Age range
20 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.
DISEASE CHARACTERISTICS:
* Biopsy-confirmed diagnosis of one of the following:
* Stage I-IV infiltrating ductal or infiltrating lobular carcinoma
* Patients with early-stage disease must not have started systemic treatment; if no systemic treatment is planned, patients must be either preoperative or ≤ 120 days since definitive breast surgery
* Patients with locally advanced disease must be scheduled for neoadjuvant chemotherapy prior to initiation of systemic treatment
* Ductal carcinoma in situ
* Lobular carcinoma in situ
* Benign breast disease
* Proliferative or non-proliferative
* With or without atypia
PATIENT CHARACTERISTICS:
* Karnofsky performance status 50-100%
* Not pregnant
* No prior invasive cancer diagnosis within the past 5 years except for squamous cell or basal cell carcinoma of the skin
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No prior systemic therapy (chemotherapy or hormonal therapy) for patients with stage I-III disease
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
Establishment of a specimen bank
Timeframe: 5 Years of specimen collection
2
Ability of the quantitative real-time reverse-transcriptase PCR (qRT-PCR) to distinguish between biopsy benign and malignant results
Timeframe: 5 years
3
Ability of the qRT-PCR to predict treatment response
Timeframe: 5 years
4
Ability of the qRT-PCR to predict relapse
Timeframe: 5 years
5
Ability of the qRT-PCR to perform as an independent prognostic factor