The Immune System's Response to Young Women's Breast Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorUniversity of Colorado, Denver
About this trial
This study plans to learn more about the immune system's response to breast cancer in young women.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Females >18.
Histological or cytological confirmation of breast cancer.
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.
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.
Disqualifiers
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.
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.)
Underlying psychiatric condition which would, in the opinion of the investigator, preclude compliance with study requirements
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.
Trial population
Women over the age of 18 who have been diagnosed with breast cancer. Women over age 46 will serve as controls. Need not be in active treatment.
Trial design
Design model
Other
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Progression Free Survival
Prospective cohort study.
Time frame
Throughout study participationSponsors and contacts
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Source ClinicalTrials.gov