No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Female
Study type
Observational
Participants needed
800 (estimated)
Sponsor
University of Colorado, Denver · Other
Who this trial is looking for
This trial is looking for young women who have been diagnosed with breast cancer. Participants will need to provide tissue samples for research and may be asked to consent over the phone or online.
Are You a Good Fit for This Trial?
Rules you outSignificant autoimmune conditionsType 1 diabetesSevere COPDHIV infection
You may be able to join if
I am a female over 18 years old
I have been diagnosed with breast cancer
I am willing to provide tissue samples for the study
I have a biopsy or tissue samples available
I am being treated at UCH, VVMC, or SCC, or I am allowed to consent by phone if treated elsewhere
I can consent to donate tissue if my treatment is complete
You may not be able to join if
I have a known significant autoimmune condition
I am using chronic oral steroids or immunomodulatory drugs
I have conditions that significantly impact my immune function
I have a psychiatric condition affecting my ability to comply with the study
I have had another type of cancer treated in the last 5 years, except certain skin cancers
I have uncontrolled diabetes or severe lung disease
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
This study plans to learn more about the immune system's response to breast cancer in young women.
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
1. Females \>18.
2. Histological or cytological confirmation of breast cancer.
3. For patients diagnosed with needle core or excisional biopsy, formalin-fixed paraffin embedded tumor blocks or unstained slides should be available or planned to be available after upcoming procedu…
Inclusion Criteria:
1. Females \>18.
2. Histological or cytological confirmation of breast cancer.
3. For patients diagnosed with needle core or excisional biopsy, formalin-fixed paraffin embedded tumor blocks or unstained slides should be available or planned to be available after upcoming procedure.
4. Patient should be willing to have fresh and/or fresh frozen tissue collected at time of core biopsy, definitive breast cancer surgery or clinically planned breast cancer metastasis biopsy/resection for research purposes as part of study procedures, if a procedure is in the future planning of the patient's treatment.
5. Any clinical stage allowed.
6. Written informed consent obtained prior to any initiation of study procedures in the case of subjects consented in clinic. Subjects consented outside of UCH, VVMC or SCC will be consented by phone and verbal informed consent will be obtained prior to any initiation of study procedures.
7. Women treated at UCH, VVMC or SCC may be pregnant. Other participants are excluded for safety reasons.
8. Women who have commenced or completed their breast cancer treatment may join this study by consenting to a retrospective tissue donation only consent of the protocol.
9. Women who receive their care at a facility other than UCH, VVMC or SCC may join this study. These women will be consented utilizing the phone consent and will receive a copy of the consent in the mail, or they will consent online and print a copy of their online consent.
Exclusion Criteria:
1. Known significant autoimmune condition \[ie Lupus, Crohne's disease or Rhuematoid Arthritis\], chronic oral steroid use, use of systemic immunomodulatory prescription drugs for any medical condition.
2. The presence of other comorbid conditions known to significantly impact immune function, (such as: type I diabetes, uncontrolled adult onset diabetes, severe COPD, uncontrolled infection or known HIV infection.)
3. Underlying psychiatric condition which would, in the opinion of the investigator, preclude compliance with study requirements
4. Subjects with a history of other malignancy besides current diagnosis of breast cancer who were diagnosed and treated within the last 5 years are excluded, with exception of cervical cancer definitively treated more than 2 years ago or non-melanomatous skin cancer.
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