CANscriptTM Clinical Outcomes in a Real-World Setting (ANCERS)-2: A Prospective, Multicenter, Observational Study Examining the Clinical Utility of CANscriptTM in Routine Clinical Practice
Status: Suspended
Location: See all (30) locations...
Intervention Type: Diagnostic test
Study Type: Observational
SUMMARY
The purpose of this study is to test the CANscript™ sensitivity assay, which is a new and different assay developed to test the sensitivity of different cancer types to physician selected therapies (both drugs and/or drug combinations) indicated for the stage and type of cancer for treatment. CANscript™ tests how a patients specific tumor reacts to the therapies being considered by the treating physician. CANscript™ test results have been shown to closely correspond with actual clinical results, providing physicians with information that may help him/her develop a more personalized cancer treatment and care plan based on the patients specific condition. The researchers want to see if CANscript™ test results are helpful in selecting the treatments prescribed and provided. There will be about 800 people taking part in this study, across 5 different tumor types. The study is designed to assess the decision impact of the CANscript™ test results in informing physicians in therapy selection.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
View:
• Male or female patient ≥18 years old
• ECOG performance status of ≤ 2
• The patient's tumor must be amenable to a tumor biopsy sampling, so that CANscript can be performed
• The patient must have disease that is measurable by standard imaging techniques, per the RECIST 1.1 (For patients with prior radiation therapy, measurable lesions must be outside of any prior radiation field\[s\], unless disease progression has been documented at that disease site subsequent to radiation)
• Histologically- or cytologically-confirmed:
• A Locally advanced or metastatic HNSCC; B Locally advanced or metastatic TNBC; C Locally advanced or metastatic Stage 3b or 4 NSCLC after failure of appropriate 1st line therapy (i) Patients with EGFR or ALK mutations must have received previous appropriate therapy; D Locally advanced or metastatic epithelial ovarian, fallopian tube, or primary peritoneal carcinoma, after failure of 1st line platinum-based chemotherapy (i) Recurrent or persistent stage 3 or 4 disease requiring relapse histologic documentation; E Stage IV metastatic CRC
• Patient has signed informed consent prior to initiation of any study-specific procedures
Locations
United States
Arizona
Banner MD Anderson Cancer Center
Gilbert
Colorado
University of Colorado School of Medicine-Denver
Aurora
Connecticut
Eastern CT Hematology and Oncology Associates
Norwich
Florida
Lynn Cancer Institute
Boca Raton
Broward Oncology Associates
Fort Lauderdale
Holy Cross Hospital
Fort Lauderdale
University of Miami-Sylvester Comprehensive Cancer Center
Miami
The Center for Gyencologic Oncology
Miramar
Florida Hospital Cancer Institute
Orlando
Tallahassee Memorial Cancer Center
Tallahassee
Georgia
Memorial Health University Medical Center- Savannah Health Services
Savannah
Illinois
Joliet Oncology Associates
Joliet
Edward Elmhurst Healthcare
Naperville
Indiana
Community Hospital
Munster
Louisiana
Ochsner Health System
New Orleans
Massachusetts
Southcoast Centers for Cancer Care
Fairhaven
Michigan
Michigan Center of Medical Research -MHP
Farmington Hills
St John Hospital and Medical Center (Great Lakes Cancer Managment Specialists)
Grosse Pointe Woods
War Memorial Hematology/Oncology
Sault Sainte-marie
Missouri
Mercy Hospital
Saint Louis
New York
University of Rochester/Wilmot Cancer Institute
Rochester
Tennessee
Saint Thomas Health
Nashville
Texas
Austin Cancer Centers
Austin
Doctors Hospital at Renaissance-DHR Health
Edinburg
University of Texas Medical Branch at Galveston(UTMB)
Galveston
Baylor College of Medicine Hemtology/Oncology
Houston
Houston Methodist Medical Center
Houston
Oncology Consultants
Houston
The University of Texas Health Science Center at Houston- Hermann
Houston
Invesclinic US McAllen Oncology
Mcallen
Time Frame
Start Date:2017-07-13
Completion Date:2019-12-15
Participants
Target number of participants:800
Treatments
Squamous Carcinoma of the Head and Neck (HNSCC)
1st line metastatic/locally advanced~* 2nd line metastatic/locally advanced
Triple Negative Breast Cancer (TNBC)
1. Triple Negative Breast Cancer (TNBC) A 1st line metastatic/locally advanced B ≥2nd line metastatic/locally advanced
Non-small Cell Lung Cancer (NSCLC)
1. Non-small Cell Lung Cancer (NSCLC) A ≥2nd line Stage 3B or 4
Epithelial Ovarian Cancer (EOC)
1. Epithelial Ovarian Cancer (EOC) A 2nd line platinum-resistant Stage 3 or 4 B 2nd line platinum-sensitive Stage 3 or 4 C ≥3rd line platinum-sensitive Stage 3 or 4
Colorectal Cancer (CRC)
1. Colorectal Cancer (CRC) A 1st line Stage 4 B Recurrent or progressive disease following treatment with both oxaliplatin- and irinotecan-containing regimens