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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02965755
Other study ID # J16146
Secondary ID IRB00117742
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date January 26, 2018
Est. completion date July 2024

Study information

Verified date October 2023
Source Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 200
Est. completion date July 2024
Est. primary completion date July 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Treatment recommendation
Depending on the results from the participant's archival tissue, a panel of Johns Hopkins investigators will meet to interpret the molecular and genetic profiling results in order to identify any actionable mutations to provide a personalized treatment recommendation for the patient.

Locations

Country Name City State
United States Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore Maryland
United States Allegheny Health Network Cancer Institute Pittsburgh Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Foundation Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Ability of genetically profiling of ptDNA as assessed by identifying the proportion of genetic alterations in tumor tissue The proportion of genetic alterations in tumor tissue is detected via genetic profiling of ptDNA when those genetic alterations are present in the tumor at an allelic frequency >10%. 1 year
Primary Percentage of patients who cannot have NGS of metastatic site biopsy but have clinically actionable mutations detected via genetic profiling of ptDNA Percentage of patients for which genetic profiling of ptDNA would be more feasible when a metastatic biopsy cannot be acquired. 1 year
Secondary Response as assessed by change in ptDNA level up to 2 weeks post-intervention. To determine whether a 10-fold decrease in allelic frequency of a given mutation in ptDNA after initiating new systemic therapy can predict for response to treatment. Change in number-of-folds decrease in allelic frequency of a given mutation in ptDNA 1 or 2 weeks after beginning new systemic therapy. 2 weeks
Secondary Response as assessed by Change in Circulating tumor cell (CTC) counts Measure CTC counts at baseline, after 1-2 weeks of therapy, and at each restaging, up to 1 year. Change from baseline up to 1 year
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