ChemoFx® PRO - A Post-Market Data Collection Study
ChemoFx® PRO - A Post-Market Data Collection Study Utilizing Physician Reported Outcomes
연구 개요
상세 설명
The traditional treatment course for new cases of many cancers is cytoreductive surgery followed by chemotherapy. Unfortunately, despite high initial response rates to treatment, the majority of patients recur. The use of ineffective chemotherapy can result in unnecessary toxicity and costs, delay of more effective treatment, and the potential for the development of cross-resistance to additional drugs. The ability to individualize therapy by providing the treating physician with ex vivo response information on a panel of drugs should aid in the selection of effective therapy for individual patients, thus resulting in improved outcomes.
ChemoFx® is a drug response marker that quantifies an individual cancer patient's probable tumor response to various chemotherapeutic and biologic agents-providing both sensitivity and resistance information. In a retrospective study, it was demonstrated that patients treated with a regimen that the ChemoFx® test said the patients' cells would be sensitive to, corresponded to a 3 times longer progression free interval.
In the PT-206 ChemoFx PRO® study, patients will be followed through treatment, until the patient progresses or a significant change in chemotherapy occurs. This data will be collected and analyzed to identify potential patient cohorts for the development of hypotheses for future sub-study analysis. Also, tumor pathology slides and excess tumor cells (if available) will be used to characterize common polymorphisms in drug metabolizing enzymes as well as other molecular markers potentially associated with tumor response.
The PT-206 ChemoFx PRO® Study seeks to enroll an estimated 3,000 patients from 150 academic and community-based physicians in the U.S. The patients will be treated with drugs and/or drug combinations based on the medical judgment of the treating physician. This study is not randomized.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Alabama
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Birmingham, Alabama, 미국, 35294
- University of Alabama at Birmingham
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Mobile, Alabama, 미국, 36688
- University of South Alabama
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California
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San Francisco, California, 미국, 94115
- University of California San Francisco
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Sherman Oaks, California, 미국, 91403
- Women's Cancer Center of Southern California
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Torrance, California, 미국, 91403
- GOA Torrance Memorial
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Connecticut
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Hartford, Connecticut, 미국, 06106
- Hartford Hospital
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New Haven, Connecticut, 미국, 06111
- Yale University
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Florida
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Boca Raton, Florida, 미국, 33487
- South Florida Center for Gynecologic Oncology
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Clearwater, Florida, 미국, 33756
- West Coast Gynecologic Oncology
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Coconut Creek, Florida, 미국, 33073
- Florida Center for Gynecologic Oncology
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Delray Beach, Florida, 미국, 33444
- Comprehensive Gynecologic Oncology
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Fort Lauderdale, Florida, 미국, 33308
- Caruso and Gates MDs PA
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Fort Myers, Florida, 미국, 33901
- Florida Gynecologic Oncology
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Hollywood, Florida, 미국, 33021
- Gynecologic Oncology Associates
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Sarasota, Florida, 미국, 34239
- Sarasota Memorial Hospital
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South Miami, Florida, 미국, 33143
- South Miami Gynecologic Oncology Group
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West Palm Beach, Florida, 미국, 33401
- Palm Beach Cancer Institute
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Georgia
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Riverdale, Georgia, 미국, 30274
- Southeastern Gynecologic Oncology, LLC
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Savannah, Georgia, 미국, 31404
- Memorial Health University Medical Center
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Hawaii
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Honolulu, Hawaii, 미국, 96813
- The Queens' Medical Center
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Illinois
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Chicago, Illinois, 미국, 60612
- Rush University
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Evanston, Illinois, 미국, 60201
- Northshore Medical Group
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Indiana
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Indianapolis, Indiana, 미국, 46202
- Indiana University
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Louisiana
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Covington, Louisiana, 미국, 70433
- Women's Cancer Center
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Shreveport, Louisiana, 미국, 71101
- CHRISTUS Schumpert Health System
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Maryland
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Baltimore, Maryland, 미국, 21215
- Sinai Hospital
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Silver Springs, Maryland, 미국, 20852
- Women's Health Specialists
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Massachusetts
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Worcester, Massachusetts, 미국, 01605
- UMass Memorial Hospital
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Michigan
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Detroit, Michigan, 미국, 48201
- Karmanos Cancer Institute
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Detroit, Michigan, 미국, 48202
- Henry Ford Health System
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Grand Rapids, Michigan, 미국, 49546
- Gynecologic Oncology of West Michigan
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Mississippi
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Jackson, Mississippi, 미국, 39216
- Mississippi Oncology Associates
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New Jersey
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Morristown, New Jersey, 미국, 07962
- Atlantic Health Systems
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Neptune, New Jersey, 미국, 07765
- Jersey Shore University Medical Center
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Teaneck, New Jersey, 미국, 07066
- Gara M Sommers MD
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Voorhees, New Jersey, 미국, 08043
- Cooper Health System
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New York
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Albany, New York, 미국, 12208
- Women's Cancer Care Associates
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Atlantic Beach, New York, 미국, 11509
- St. John's Episcopal Hospital
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Bronx, New York, 미국, 10461
- Montefiore Medical Center
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Buffalo, New York, 미국, 14263
- Roswell Park Cancer Institute
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Manhassett, New York, 미국, 11030
- North Shore Lij Health System
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New York, New York, 미국, 10032
- Columbia University Medical Center
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New York, New York, 미국, 10038
- New York Downtown Hospital
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North Carolina
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Asheville, North Carolina, 미국, 28806
- Hope: A Women's Cancer Center
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Charlotte, North Carolina, 미국, 28204
- Blumenthal Cancer Center
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Charlotte, North Carolina, 미국, 28233
- Presbyterian Gynecologic Oncology
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Durham, North Carolina, 미국, 27710
- Duke University Medical Center
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Wilmington, North Carolina, 미국, 28402
- North Hanover Regional Medical Center
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Ohio
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Cincinnati, Ohio, 미국, 45267
- University of Cincinnati
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Columbus, Ohio, 미국, 43026
- OSU Gynecologic Oncology
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Oklahoma
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Oklahoma City, Oklahoma, 미국, 73112
- Oklahoma Gynecologic Oncology Group
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Oregon
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Portland, Oregon, 미국, 97239
- Oregon Health & Science University
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Pennsylvania
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Pittsburgh, Pennsylvania, 미국, 15224
- The Western Pennsylvania Hospital
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Pittsburgh, Pennsylvania, 미국, 15224
- Allegheny-Singer Research Institute
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Rhode Island
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Providence, Rhode Island, 미국, 02905
- Women & Infants Hospital of Rhode Island
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South Carolina
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Charleston, South Carolina, 미국, 29403
- Medical University of South Carolina Hospital
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South Dakota
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Sioux Falls, South Dakota, 미국, 57105
- Sandford USD Health System
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Tennessee
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Chattanooga, Tennessee, 미국, 37403
- Chattanooga's Program In Women's Oncology
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Chattanooga, Tennessee, 미국, 37403
- Chattanooga Gynecologic Oncology
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Knoxville, Tennessee, 미국, 37922
- Thomas W. McDonald MD
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Texas
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Dallas, Texas, 미국, 75251
- North Texas Gynecologic Oncology
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Ft. Sam Houston, Texas, 미국, 78234
- Brooke Army Medical Center
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San Antonio, Texas, 미국, 78258
- South Texas Gynecologic Oncology
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Virginia
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Annandale, Virginia, 미국, 22003
- North Virigina Pelvic Surgery Associates
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Roanoke, Virginia, 미국, 24016
- Carilion Clinic Gynecologic Oncology
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West Virginia
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Morgantown, West Virginia, 미국, 26505
- Mohammed Ashraf MD
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Wisconsin
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West Allis, Wisconsin, 미국, 53227
- Aurora West Allis Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
Approximately 3,000 patients from 150 academic and community based physicians in the United States.
Patients have a confirmed solid tumor malignancy and their tissue specimen has been submitted to Precision Therapeutics, Inc. as part of the patient's medical care
설명
Inclusion Criteria:
- Patient has been diagnosed with a solid tumor malignancy and their physician has received a final report for ChemoFx® after August 1, 2006
- Chemotherapy must be clinically indicated for treatment of the patient's qualifying disease
- Patient must be at least 18 years of age
- Patient must have signed an IRB approved informed consent form for the data collection study prior to entry of data into the enrollment form in the database.
Exclusion Criteria:
- Patient pathology shows benign pathology for sample submitted
- Patient is not indicated to receive chemotherapy for their disease
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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To collect physician reported outcomes after the first chemotherapy utilized following the receipt of a final report from ChemoFx® in solid tumor malignancies for the generation of hypotheses for further sub-study.
기간: 24-36 Months depending on Disease Status
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24-36 Months depending on Disease Status
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Identify possible enhancements of the predictive and prognostic capabilities of the assay through the inclusion of molecular markers.
기간: 24-36 Months depending on Disease Status
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24-36 Months depending on Disease Status
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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Jemal A, Tiwari RC, Murray T, Ghafoor A, Samuels A, Ward E, Feuer EJ, Thun MJ; American Cancer Society. Cancer statistics, 2004. CA Cancer J Clin. 2004 Jan-Feb;54(1):8-29. doi: 10.3322/canjclin.54.1.8.
- Ness RB, Wisniewski SR, Eng H, Christopherson W. Cell viability assay for drug testing in ovarian cancer: in vitro kill versus clinical response. Anticancer Res. 2002 Mar-Apr;22(2B):1145-9.
- O'Meara AT, Sevin BU. Predictive value of the ATP chemosensitivity assay in epithelial ovarian cancer. Gynecol Oncol. 2001 Nov;83(2):334-42. doi: 10.1006/gyno.2001.6395.
- McLeod HL, King CR, Marsh S. Application of pharmacogenomics in the individualization of chemotherapy for gastrointestinal malignancies. Clin Colorectal Cancer. 2004 Jun;4 Suppl 1:S43-7. doi: 10.3816/ccc.2004.s.007.
연구 기록 날짜
연구 주요 날짜
연구 시작
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
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- PT-206 ChemoFx® PRO Study
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