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Ovarian CancerNCT00669422

ChemoFx® PRO - A Post-Market Data Collection Study

An observational study of Ovarian Cancer and Fallopian Tube Cancer, run by Precision Therapeutics at 67 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study will collect patient demographic, oncology history, and physician reported outcome information following the initial round of chemotherapy received after a commercial ChemoFx® Final Report for the generation of hypotheses of potential patient cohorts for further sub-studies. Read more about this study

Who is it for?
Ages 18 years and older, women only
How many people
2,756 participants
Where
67 sitesUnited States
Study dates
Oct 2006to Oct 2012
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: 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

Who may be able to join

  • 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.

Who cannot join

  • Patient pathology shows benign pathology for sample submitted
  • Patient is not indicated to receive chemotherapy for their disease

Trial locations and contacts

67 sites in 1 country.

67 sites in 1 country

United States67 sites

  • Women's Cancer Care Associates

    Albany, New York, 12208

  • North Virigina Pelvic Surgery Associates

    Annandale, Virginia, 22003

  • Hope: A Women's Cancer Center

    Asheville, North Carolina, 28806

  • St. John's Episcopal Hospital

    Atlantic Beach, New York, 11509

  • Sinai Hospital

    Baltimore, Maryland, 21215

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • South Florida Center for Gynecologic Oncology

    Boca Raton, Florida, 33487

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Medical University of South Carolina Hospital

    Charleston, South Carolina, 29403

  • Blumenthal Cancer Center

    Charlotte, North Carolina, 28204

  • Presbyterian Gynecologic Oncology

    Charlotte, North Carolina, 28233

  • Chattanooga Gynecologic Oncology

    Chattanooga, Tennessee, 37403

  • Chattanooga's Program in Women's Oncology

    Chattanooga, Tennessee, 37403

  • Rush University

    Chicago, Illinois, 60612

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • West Coast Gynecologic Oncology

    Clearwater, Florida, 33756

  • Florida Center for Gynecologic Oncology

    Coconut Creek, Florida, 33073

  • OSU Gynecologic Oncology

    Columbus, Ohio, 43026

  • Women's Cancer Center

    Covington, Louisiana, 70433

  • North Texas Gynecologic Oncology

    Dallas, Texas, 75251

  • Comprehensive Gynecologic Oncology

    Delray Beach, Florida, 33444

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • NorthShore Medical Group

    Evanston, Illinois, 60201

  • Caruso and Gates MDs PA

    Fort Lauderdale, Florida, 33308

  • Florida Gynecologic Oncology

    Fort Myers, Florida, 33901

  • Brooke Army Medical Center

    Fort Sam Houston, Texas, 78234

  • Gynecologic Oncology of West Michigan

    Grand Rapids, Michigan, 49546

  • Hartford Hospital

    Hartford, Connecticut, 06106

  • Gynecologic Oncology Associates

    Hollywood, Florida, 33021

  • The Queens' Medical Center

    Honolulu, Hawaii, 96813

  • Indiana University

    Indianapolis, Indiana, 46202

  • Mississippi Oncology Associates

    Jackson, Mississippi, 39216

  • Thomas W. McDonald MD

    Knoxville, Tennessee, 37922

  • North Shore LIJ Health System

    Manhassett, New York, 11030

  • University of South Alabama

    Mobile, Alabama, 36688

  • Mohammed Ashraf MD

    Morgantown, West Virginia, 26505

  • Atlantic Health Systems

    Morristown, New Jersey, 07962

  • Jersey Shore University Medical Center

    Neptune City, New Jersey, 07765

  • Yale University

    New Haven, Connecticut, 06111

  • Columbia University Medical Center

    New York, New York, 10032

  • New York Downtown Hospital

    New York, New York, 10038

  • Oklahoma Gynecologic Oncology Group

    Oklahoma City, Oklahoma, 73112

  • Allegheny-Singer Research Institute

    Pittsburgh, Pennsylvania, 15224

  • The Western Pennsylvania Hospital

    Pittsburgh, Pennsylvania, 15224

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • Women & Infants Hospital of Rhode Island

    Providence, Rhode Island, 02905

  • Southeastern Gynecologic Oncology, LLC

    Riverdale, Georgia, 30274

  • Carilion Clinic Gynecologic Oncology

    Roanoke, Virginia, 24016

  • South Texas Gynecologic Oncology

    San Antonio, Texas, 78258

  • University of California San Francisco

    San Francisco, California, 94115

  • Sarasota Memorial Hospital

    Sarasota, Florida, 34239

  • Memorial Health University Medical Center

    Savannah, Georgia, 31404

  • Women's Cancer Center of Southern California

    Sherman Oaks, California, 91403

  • CHRISTUS Schumpert Health System

    Shreveport, Louisiana, 71101

  • Women's Health Specialists

    Silver Springs, Maryland, 20852

  • Sandford USD Health System

    Sioux Falls, South Dakota, 57105

  • South Miami Gynecologic Oncology Group

    South Miami, Florida, 33143

  • Gara M Sommers MD

    Teaneck, New Jersey, 07066

  • Montefiore Medical Center

    The Bronx, New York, 10461

  • GOA Torrance Memorial

    Torrance, California, 91403

  • Cooper Health System

    Voorhees Township, New Jersey, 08043

  • Aurora West Allis Medical Center

    West Allis, Wisconsin, 53227

  • Palm Beach Cancer Institute

    West Palm Beach, Florida, 33401

  • North Hanover Regional Medical Center

    Wilmington, North Carolina, 28402

  • UMass Memorial Hospital

    Worcester, Massachusetts, 01605

Other trials in United States

About this study

Official title: ChemoFx® PRO - A Post-Market Data Collection Study Utilizing Physician Reported Outcomes

This study will collect patient demographic, oncology history, and physician reported outcome information following the initial round of chemotherapy received after a commercial ChemoFx® Final Report for the generation of hypotheses of potential patient cohorts for further sub-studies.

Read the detailed description

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.

Keywords
Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer, Uterine Neoplasms, Vulvar Cancer, Endometrial Cancer, Cervical Cancer, Assay, Chemotherapy, Recurrent, Refractory, Persistent, Chemoresponse, Sensitivity, Precision Therapeutics, ChemoFx
Medical subject headings
Ovarian Neoplasms, Fallopian Tube Neoplasms, Uterine Neoplasms, Endometrial Neoplasms, Vaginal Neoplasms, Vulvar Neoplasms, Uterine Cervical Neoplasms, Recurrence

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 24-36 Months depending on Disease Status

Secondary outcomes (1)

  1. Identify possible enhancements of the predictive and prognostic capabilities of the assay through the inclusion of molecular markers.

    Measured: 24-36 Months depending on Disease Status

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2008 (estimated)
  2. Study startOct 2006
  3. Study completionOct 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
2,756 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00669422
Sponsor's protocol ID
PT-206 ChemoFx® PRO Study
Status last verified
Oct 2012
First submitted
25 Apr 2008
Last updated
5 Oct 2012
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 14974761

  • 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.

    PubMed 12168915

  • 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.

    PubMed 11606094

  • 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.

    PubMed 15212705

Questions about this trial

What is this clinical trial studying?

An observational study of Ovarian Cancer and Fallopian Tube Cancer, run by Precision Therapeutics at 67 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 67 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: 24-36 Months depending on Disease Status). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00669422, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2012.

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