Solid Organ TumorsNCT01271959
A Study of ChemoFx® Chemoresponse Assay in Solid Tumors - ChemoFx® Registry Study
An observational study of Solid Organ Tumors, run by Precision Therapeutics at 25 sites in United States.
Trial summary
The purpose of this research study is to collect information from patient's medical records that had a test called ChemoFx® ordered and to understand how doctors may have used the results of the ChemoFx® to treat patients with cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Organ Tumors
- How many people
- 167 participants
- Where
- 25 sitesUnited States
- Study dates
- Nov 2010to 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with solid tumor malignancies
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
Albany Thoracic & Esophageal Surgery
Albany, New York, 12208
Cardio-Thoracic Surgeons, P.C.
Birmingham, Alabama, 35213
Collaborative Research Group
Boynton Beach, Florida, 33435
Center for Clinical Research and Technology University Hospitals of Cleveland
Cleveland, Ohio, 44106
Iowa Clinic
Des Moines, Iowa, 50309
North Shore Hematology Oncology
East Setauket, New York, 11733
The Regional Cancer Center
Erie, Pennsylvania, 16505
The New York Hospital Medical Center of Queens
Flushing, New York, 11355
Broward Oncology Associates, P.A.
Fort Lauderdale, Florida, 33308
Grand Blanc Surgical Specialist
Grand Blanc, Michigan, 48439
The Center For Gynecologic Oncology
Hollywood, Florida, 33021
Barry S Siller MD
Houston, Texas, 77024
Colorectal Surgical Associates
Houston, Texas, 77054
Northwest Cancer Center
Houston, Texas, 77090
Central Baptist Hospital Clinical Research Center
Lexington, Kentucky, 40503
GYN Oncology of Miami
Miami, Florida, 33143
Miami International Surgical Services
Miami, Florida, 33173
Winthrop University Hospital
Mineola, New York, 11501
Heiskell, King, Burns & Tallman Surgical Associates, Inc.
Morgantown, West Virginia, 26508
Hematology Oncology Associates
Oakland, California, 94609
Orlando Cardiovascular Institute PA
Orlando, Florida, 32804
Oncology Associates of West Kentucky
Paducah, Kentucky, 42003
Cancer Care Centers of South Texas
San Antonio, Texas, 78229
Edward H. Kaplan, M.D. & Associates
Skokie, Illinois, 60076
Cancer Care Northwest
Spokane, Washington, 99202
About this study
Official title: A Multicenter, Post-Market Follow-up Study of ChemoFx® Chemoresponse Assay in Solid Tumors - ChemoFx® Registry Study
The purpose of this research study is to collect information from patient's medical records that had a test called ChemoFx® ordered and to understand how doctors may have used the results of the ChemoFx® to treat patients with cancer.
Read the detailed description
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.
- Conditions
- Solid Organ Tumors
- Keywords
- Ovarian, Fallopian Tube, Peritoneal, Uterine Neoplasms, Vulva, Endometrial, Cervical, Lung, Carcinoid, Sarcoma, Mesothelioma, Adenocarcinoma, Colorectal, Breast, Assay, Chemotherapy, Recurrent, Refractory, Persistent, Chemoresponse
- Medical subject headings
- Uterine Neoplasms, Carcinoid Tumor, Sarcoma, Mesothelioma, Adenocarcinoma, Recurrence
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine physicians' rate of compliance with ChemoFx assay results in the treatment of subjects with solid tumors.
Measured: Analysis of assay-directed compliance will be conducted immediately after information is collected.
To investigate the association between the results of Precision's ChemoFx assay results and overall survival in subjects with solid tumors.
Measured: From date of first dose of on-study chemotherapy to date of death or last known alive.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2011 (estimated)
- Study startNov 2010
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Organ TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Retrospective
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Precision Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karl Williams, M.D., Principal investigator, Precision Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01271959
- Sponsor's protocol ID
- PT-207
- Status last verified
- Oct 2012
- First submitted
- 5 Jan 2011
- Last updated
- 5 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Post-Market Follow-up Study of ChemoFx® Chemoresponse Assay in Solid Tumors - ChemoFx® Registry Study
- ClinicalTrials.gov ID
- NCT01271959
- Acronym / sponsor ID
- PT-207
- Conditions
- Solid Organ Tumors
- Keywords
- Ovarian, Fallopian Tube, Peritoneal, Uterine Neoplasms, Vulva, Endometrial, Cervical, Lung
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Precision TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 7 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to collect information from patient's medical records that had a test called ChemoFx® ordered and to understand how doctors may have used the results of the ChemoFx® to treat patients with cancer.
Detailed description
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.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with solid tumor malignancies
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To determine physicians' rate of compliance with ChemoFx assay results in the treatment of subjects with solid tumors.
Time frame: Analysis of assay-directed compliance will be conducted immediately after information is collected.
To investigate the association between the results of Precision's ChemoFx assay results and overall survival in subjects with solid tumors.
Time frame: From date of first dose of on-study chemotherapy to date of death or last known alive.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karl Williams, M.D. principal investigator
Precision Therapeutics, Inc.
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Solid Organ Tumors, run by Precision Therapeutics at 25 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 6 inclusion and 4 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 25 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 determine physicians' rate of compliance with ChemoFx assay results in the treatment of subjects with solid tumors. (time frame: Analysis of assay-directed compliance will be conducted immediately after information is collected.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.