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Trial Title:
The Immune System's Response to Young Women's Breast Cancer
NCT ID:
NCT01503190
Condition:
Breast Cancer
Breast Cancer and Pregnancy
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Breast Cancer
Young Women
Pregnancy Associated Breast Cancer
Pregnancy
Premenopausal Breast Cancer
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Retrospective
Summary:
This study plans to learn more about the immune system's response to breast cancer in
young women.
Detailed description:
The investigators will be looking at the level of immune suppression in different types
of breast cancer. The investigators will use blood, urine, and tissue samples from
patients with Pregnancy Associated Breast Cancer (PABC) versus non-PABC, as well as
comparing different types of breast cancer. If tissue sampling permits, the investigators
may use some of the breast cancer tissue to develop models for human cancer for drug
targeting. Understanding the immune response and suppression in different types of cancer
will help us understand mechanisms involved in breast cancer better and help the
investigators in developing new treatment in the future.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
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 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.
Gender:
Female
Gender based:
Yes
Gender description:
The study is restricted by gender due to the population of interest being women with
pregnancy associated breast cancer and appropriately matched age controls.
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Colorado Denver
Address:
City:
Aurora
Zip:
80045
Country:
United States
Status:
Recruiting
Contact:
Last name:
Hannah Parris
Phone:
720-848-4170
Email:
hannah.parris@cuanschutz.edu
Investigator:
Last name:
Virginia Borges, MD, MMSc
Email:
Principal Investigator
Start date:
July 21, 2009
Completion date:
July 2027
Lead sponsor:
Agency:
University of Colorado, Denver
Agency class:
Other
Source:
University of Colorado, Denver
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01503190
