Personalized Molecular Profiling in Cancer Treatment at Johns Hopkins (IMAGE-II)

Johns Hopkins Medicine

Status: Active, not recruiting

Conditions: Metastatic Breast Cancer

Treatments: Other: Treatment recommendation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02965755

IRB00117742 (Other Identifier)

J16146

Details and patient eligibility

About

The goal of this research study is to determine if we can obtain personalized genetic information from a subject's blood sample that is similar to that obtained from a tumor tissue sample, and if we can use that information to make treatment suggestions.

Full description

The goal of this research study is to determine if we can obtain personalized genetic information from a subject's blood sample that is similar to that obtained from a tumor tissue sample, and if we can use that information to make treatment suggestions. As tumor samples can be difficult to collect, we hope to be able to collect similar genetic information from blood or urine samples that we find in tumor tissue. Ultimately, we hope to identify genes important to cancer cells that could potentially identify standard-of-care or research-based recommendations for therapy.

Enrollment: 200 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or Female
• 18 years of age or older
• Metastatic breast cancer and treatment with prior chemotherapy
• Any clinical phenotype (Triple negative, Hormone receptor positive, human epidermal growth factor receptor 2 (HER2)-positive)
• Patient must have received a metastatic tumor biopsy within 3 years prior to the date of the first planned blood sample for the study and have tissue available from this biopsy
• Able to voluntarily provide informed consent

Exclusion criteria

• Women who are pregnant or nursing

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Genetic profiling

Other group

Description:

All participants will undergo genetic profiling. Archival tissue will be requested to undergo routine review for possible treatment recommendations. Blood samples will be obtained to study research correlates (plasma tumor DNA, ptDNA) and tissue comparison.

Treatment:

Other: Treatment recommendation