IMAGE Study: Personalized Molecular Profiling in Cancer Treatment at Johns Hopkins
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/2/2019 |
| Start Date: | September 19, 2013 |
| End Date: | February 1, 2017 |
IMAGE Study: Individualized Molecular Analyses Guide Efforts in Breast Cancer - Personalized Molecular Profiling in Cancer Treatment at Johns Hopkins
This study will test the feasibility of identifying patients who could benefit from tumor
molecular profiling, of analyzing the patients' tumors in a timely (28 day) fashion, and of
the identification of possible actionable mutations that are not just biologically
interesting but are clinically relevant. The investigators will also examine the outcome data
from patients who followed the Molecular Profiling Tumor Board suggestion compared with those
who did not.
When the tissue studies are done, an additional group of patients will be enrolled to test if
the same is possible in blood samples.
molecular profiling, of analyzing the patients' tumors in a timely (28 day) fashion, and of
the identification of possible actionable mutations that are not just biologically
interesting but are clinically relevant. The investigators will also examine the outcome data
from patients who followed the Molecular Profiling Tumor Board suggestion compared with those
who did not.
When the tissue studies are done, an additional group of patients will be enrolled to test if
the same is possible in blood samples.
The goal of this research study is to determine if it is possible to obtain personalized
genetic information from a subject's tumor to see if physicians can use that information to
make a treatment suggestion. The investigators hope to identify genes important to cancer
cells that could potentially identify a more educated way to recommend therapy. It is not
known if our suggestion for treatment based on genetic information will be the correct
treatment choice.
Subjects and their treating doctor will have a choice about what treatment they will receive
and do not have to decide to be treated with the suggestion from this study. In some cases it
will not be possible to make a suggestion. For example, a suggestion for treatment will not
be possible if there are technical issues, if the gene sequencing process takes longer than
planned, or if no genes are identified that could help identify a treatment suggestion.
The investigators also plan to collect information about the treatment subjects receive and
how their cancer responds to the treatment. This may help us to understand if our
personalized suggestion improves the amount of time before their disease progresses.
In addition, blood samples will be collected for research studies. These samples are being
collected to learn more about breast cancer by studying cells, genes, and gene products
including their patterns and changes in the blood and tissue to help to learn how cancer
develops and responds to therapy.
Any man or woman being seen at Johns Hopkins for treatment of metastatic triple negative (or
behaving as triple negative) breast cancer may be eligible.
Upon conclusion of the tissue studies and in order to gain experience with and assess the
feasibility of receiving blood-based results using blood sampling kits, we will enroll an
additional cohort of patients with recent Foundation Medicine testing for clinical purposes
and collect blood samples only for research testing. The primary objectives and analysis for
this new cohort will proceed similarly as the original tissue-based cohort.
genetic information from a subject's tumor to see if physicians can use that information to
make a treatment suggestion. The investigators hope to identify genes important to cancer
cells that could potentially identify a more educated way to recommend therapy. It is not
known if our suggestion for treatment based on genetic information will be the correct
treatment choice.
Subjects and their treating doctor will have a choice about what treatment they will receive
and do not have to decide to be treated with the suggestion from this study. In some cases it
will not be possible to make a suggestion. For example, a suggestion for treatment will not
be possible if there are technical issues, if the gene sequencing process takes longer than
planned, or if no genes are identified that could help identify a treatment suggestion.
The investigators also plan to collect information about the treatment subjects receive and
how their cancer responds to the treatment. This may help us to understand if our
personalized suggestion improves the amount of time before their disease progresses.
In addition, blood samples will be collected for research studies. These samples are being
collected to learn more about breast cancer by studying cells, genes, and gene products
including their patterns and changes in the blood and tissue to help to learn how cancer
develops and responds to therapy.
Any man or woman being seen at Johns Hopkins for treatment of metastatic triple negative (or
behaving as triple negative) breast cancer may be eligible.
Upon conclusion of the tissue studies and in order to gain experience with and assess the
feasibility of receiving blood-based results using blood sampling kits, we will enroll an
additional cohort of patients with recent Foundation Medicine testing for clinical purposes
and collect blood samples only for research testing. The primary objectives and analysis for
this new cohort will proceed similarly as the original tissue-based cohort.
MOLECULAR PROFILING IN TISSUE:
Inclusion Criteria:
- Male or Female
- 18 years of age or older
- Metastatic breast cancer and treatment with prior chemotherapy (either in adjuvant,
neoadjuvant or metastatic setting)
- Triple negative clinical phenotype (ER-, PR-, HER2-). For HER2 assessment, a negative
result is an immunohistochemical (IHC staining of 0 or 1+, a FISH result of less than
4.0 HER2 gene copies per nucleus, or a FISH ratio of less than 1.8. ER/PR will be
assessed by IHC and will be defined as positive/negative using the American Society of
Clinical Oncology/College of American Pathologists (ASCO-CAP) Guidelines. Estrogen
receptor (ER) and progesterone receptor (PR) assays will be considered positive if
there are at least 1% positive tumor nuclei in the sample on testing in the presence
of expected reactivity of internal (normal epithelial elements) and external controls.
NOTE: A triple negative clinical phenotype based upon the patient's clinical course
may also be eligible as determined at the discretion of the Study Chair (ie, if a
patient is behaving clinically as ER/PR negative but does not meet the strict criteria
outlined.)
- Patients must have a tumor suitable for biopsy and be deemed medically appropriate to
undergo a biopsy
- Able to voluntarily provide informed consent
Exclusion Criteria:
MOLECULAR PROFILING IN BLOOD:
Inclusion Criteria:
- Male or Female
- 18 years of age or older
- Metastatic breast cancer
- Any phenotype of breast cancer is eligible for enrollment (i.e., any ER, PR, and HER2
status).
- Able to voluntarily provide informed consent
Exclusion Criteria:
We found this trial at
1
site
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins The name Johns Hopkins has become synonymous...
Click here to add this to my saved trials
