A Study of ChemoFx® Chemoresponse Assay in Solid Tumors - ChemoFx® Registry Study
A Multicenter, Post-Market Follow-up Study of ChemoFx® Chemoresponse Assay in Solid Tumors - ChemoFx® Registry Study
연구 개요
상태
정황
상세 설명
While studies support the clinical use of ChemoFx® in cancer patients, additional data are needed to further assess the utilization of this product in clinical practice. Such post-market data and information could be employed for product improvement as well as for the development of standards and regulations. This is a multicenter registry study of 3,000 patients with solid tumors. The study is not randomized, nor is it interventional in that the treating physician is free to choose how to employ ChemoFx® results in the clinical management of individual patients. Sites will be selected by Precision's clinical trials team based on past commercial usage of ChemoFx®.
Subjects who may be enrolled in this study are those who have been diagnosed with a solid tumor malignancy and for whom ChemoFx® has been ordered. ChemoFx® is ordered through the normal commercial process and is therefore billed to the patient's medical insurance.
All subjects will be appropriately consented before any study-specific data are collected. A limited dataset of patient demographics, oncology history, and therapeutic intervention will be collected in addition to ChemoFx® assay usage. Subjects will be treated based on the medical judgment of their treating physician(s). Patient survival data will be collected up to five years following the ChemoFx® commercial order. Additional disease progression data may be collected by Precision's CRAs at participating sites.
Optional Cell Research
Informed consent will be obtained to document subject's consent to use excess cells remaining in Precisions' commercial laboratory for additional research. This portion of the study may involve DNA, RNA, and proteomic research. To ensure the anonymity of each subject, any identifiers that would link the sample to the subject will be removed. The samples would then have gene expression profiling and or quantitative protein expression analysis performed. The goal of the research would be to identify a set of informative genes, intermediaries, and proteins and develop predictive algorithm(s) that seek to link the expression level of the gene, gene signature, intermediary, or protein to the clinical outcome of the patient. This portion of the study does not require any additional subject procedures. Neither physicians nor their patients will receive the results of the research performed. Results will not be placed in the subjects health care records and will not affect their medical care.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Alabama
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Birmingham, Alabama, 미국, 35213
- Cardio-Thoracic Surgeons, P.C.
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California
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Oakland, California, 미국, 94609
- Hematology Oncology Associates
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Florida
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Boynton Beach, Florida, 미국, 33435
- Collaborative Research Group
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Fort Lauderdale, Florida, 미국, 33308
- Broward Oncology Associates, P.A.
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Hollywood, Florida, 미국, 33021
- The Center For Gynecologic Oncology
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Miami, Florida, 미국, 33143
- GYN Oncology of Miami
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Miami, Florida, 미국, 33173
- Miami International Surgical Services
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Orlando, Florida, 미국, 32804
- Orlando Cardiovascular Institute PA
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Illinois
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Skokie, Illinois, 미국, 60076
- Edward H. Kaplan, M.D. & Associates
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Iowa
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Des Moines, Iowa, 미국, 50309
- Iowa Clinic
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Kentucky
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Lexington, Kentucky, 미국, 40503
- Central Baptist Hospital Clinical Research Center
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Paducah, Kentucky, 미국, 42003
- Oncology Associates of West Kentucky
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Michigan
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Grand Blanc, Michigan, 미국, 48439
- Grand Blanc Surgical Specialist
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New York
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Albany, New York, 미국, 12208
- Albany Thoracic & Esophageal Surgery
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East Setauket, New York, 미국, 11733
- North Shore Hematology Oncology
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Flushing, New York, 미국, 11355
- The New York Hospital Medical Center of Queens
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Mineola, New York, 미국, 11501
- Winthrop University Hospital
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Ohio
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Cleveland, Ohio, 미국, 44106
- Center for Clinical Research and Technology University Hospitals of Cleveland
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Pennsylvania
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Erie, Pennsylvania, 미국, 16505
- The Regional Cancer Center
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Texas
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Houston, Texas, 미국, 77090
- Northwest Cancer Center
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Houston, Texas, 미국, 77054
- Colorectal Surgical Associates
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Houston, Texas, 미국, 77024
- Barry S Siller MD
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San Antonio, Texas, 미국, 78229
- Cancer Care Centers of South Texas
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Washington
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Spokane, Washington, 미국, 99202
- Cancer Care Northwest
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West Virginia
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Morgantown, West Virginia, 미국, 26508
- Heiskell, King, Burns & Tallman Surgical Associates, Inc.
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Pathologically confirmed diagnosis of solid tumor malignancy;
- Medically indicated to receive chemotherapy;
- Fresh tissue submitted from the solid tumor malignancy for testing with the ChemoFx® assay after August, 2006;
- Final ChemoFx® assay report is available;
- Subject must be at least 18 years of age;
- Subject must sign and date an IRB approved ICF.
Exclusion Criteria:
- Enrolled in PT-103, PT-106, PT-206, PT-301, or PT-304;
- Pregnant or lactating subjects;
- Subjects are not indicated to receive chemotherapy for their disease;
- Subjects with psychiatric or addictive disorders that would preclude obtaining informed consent.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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To determine physicians' rate of compliance with ChemoFx assay results in the treatment of subjects with solid tumors.
기간: Analysis of assay-directed compliance will be conducted immediately after information is collected.
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Analysis of assay-directed compliance will be conducted immediately after information is collected.
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To investigate the association between the results of Precision's ChemoFx assay results and overall survival in subjects with solid tumors.
기간: From date of first dose of on-study chemotherapy to date of death or last known alive.
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From date of first dose of on-study chemotherapy to date of death or last known alive.
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공동 작업자 및 조사자
수사관
- 수석 연구원: Karl Williams, M.D., Precision Therapeutics, Inc.
간행물 및 유용한 링크
유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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