IUCRO-0209; The Susan G. Komen for a Cure Tissue Bank at IU Simon Cancer Center Collection and Storage of Biological Specimens Intended for Use in the Elucidation of Breast Carcinogenesis
Research Study on Specimen Collection from Women with and without Breast Cancer
Brief description of study.
The purpose of this study is to obtain and store specimens (tissue, blood, urine, or saliva) from subjects without diagnosed breast cancer compared to subjects with breast cancer.
Detailed description of study
The purpose of this study is to obtain and store specimens (tissue, blood, urine, or saliva) from subjects without diagnosed breast cancer compared to subjects with breast cancer.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Breast Carcinogenesis
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Age: 18 years - 100 years
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Gender: Female
Inclusion Criteria
1. Women ages ≥ 18 years without known breast cancer.
2. Women ages ≥ 18 with Stage 0-III breast cancer may donate tissue from the uninvolved breast and may donate blood.
-If women have not had definitive surgery for newly diagnosed breast cancer, they may donate samples from both the involved and uninvolved breast.
-For women with Stage 0-III breast cancer who intend to donate breast tissue: Concurrent hormonal treatment is permitted (tamoxifen, aromatase inhibitors, etc…). Women receiving chemotherapy or biological therapy for their breast cancer cannot have had treatment within 90 days prior to tissue donation.
-Women who have Stage IV breast cancer are not able to donate breast tissue but may participate in all other aspects of the study
Exclusion Criteria
1. For the purpose of invasive breast biopsies, women may not have breast implants in place.
-Women who have undergone breast reduction surgery are permitted to donate breast tissue, so long as the surgery is noted on their medical questionnaire
2. Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
3. For biopsy of breast tissue only: History of serious or life-threatening allergic reaction to local anesthetics (i.e. lidocaine, xylocaine)
4. Anti-coagulation. For the purpose of invasive breast biopsies, women may not be receiving therapeutic anticoagulants. For blood draws, anticoagulants will be permitted.
5. Women with known clotting or bleeding disorders
6. Any other condition, which in the opinion of the physician performing the biopsy procedure would make participation in this protocol unreasonably hazardous for the subject.
7. The breast intended for tissue donation cannot have had prior therapeutic radiation.
8. Any radiation to the whole chest wall.
This study investigates the collection and storage of specimens such as tissue, blood, urine, or saliva from women with and without diagnosed breast cancer. The purpose is to compare these samples between the two groups, which can help in understanding the differences in biological markers.
Participants will undergo procedures to collect these specimens. For those with breast cancer, samples may be taken from both the involved and uninvolved breast if they have not had surgery yet. The study also allows women with Stage 0-III breast cancer to donate tissue and blood, while those with Stage IV can participate in other study aspects.
- Who can participate: Women aged 18 and older, both with and without breast cancer, are eligible. Those with early-stage breast cancer (Stage 0-III) can donate tissue and blood, while those with Stage IV can participate in other study aspects.
- Study details: Participants will donate specimens such as tissue, blood, urine, or saliva. An inactive substance that looks like the investigational medicine/vaccine but does not contain any medicine may be used. Women should not have received chemotherapy or biological therapy within 90 days. Women with breast implants or certain medical conditions may be excluded.