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
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Alabama
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Birmingham、Alabama、アメリカ、35213
- Cardio-Thoracic Surgeons, P.C.
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California
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Oakland、California、アメリカ、94609
- Hematology Oncology Associates
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Florida
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Boynton Beach、Florida、アメリカ、33435
- Collaborative Research Group
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Fort Lauderdale、Florida、アメリカ、33308
- Broward Oncology Associates, P.A.
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Hollywood、Florida、アメリカ、33021
- The Center For Gynecologic Oncology
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Miami、Florida、アメリカ、33143
- GYN Oncology of Miami
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Miami、Florida、アメリカ、33173
- Miami International Surgical Services
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Orlando、Florida、アメリカ、32804
- Orlando Cardiovascular Institute PA
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Illinois
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Skokie、Illinois、アメリカ、60076
- Edward H. Kaplan, M.D. & Associates
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Iowa
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Des Moines、Iowa、アメリカ、50309
- Iowa Clinic
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Kentucky
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Lexington、Kentucky、アメリカ、40503
- Central Baptist Hospital Clinical Research Center
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Paducah、Kentucky、アメリカ、42003
- Oncology Associates of West Kentucky
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Michigan
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Grand Blanc、Michigan、アメリカ、48439
- Grand Blanc Surgical Specialist
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New York
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Albany、New York、アメリカ、12208
- Albany Thoracic & Esophageal Surgery
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East Setauket、New York、アメリカ、11733
- North Shore Hematology Oncology
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Flushing、New York、アメリカ、11355
- The New York Hospital Medical Center of Queens
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Mineola、New York、アメリカ、11501
- Winthrop University Hospital
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Ohio
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Cleveland、Ohio、アメリカ、44106
- Center for Clinical Research and Technology University Hospitals of Cleveland
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Pennsylvania
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Erie、Pennsylvania、アメリカ、16505
- The Regional Cancer Center
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Texas
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Houston、Texas、アメリカ、77090
- Northwest Cancer Center
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Houston、Texas、アメリカ、77054
- Colorectal Surgical Associates
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Houston、Texas、アメリカ、77024
- Barry S Siller MD
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San Antonio、Texas、アメリカ、78229
- Cancer Care Centers of South Texas
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Washington
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Spokane、Washington、アメリカ、99202
- Cancer Care Northwest
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West Virginia
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Morgantown、West Virginia、アメリカ、26508
- Heiskell, King, Burns & Tallman Surgical Associates, Inc.
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
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To determine physicians' rate of compliance with ChemoFx assay results in the treatment of subjects with solid tumors.
時間枠: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.
時間枠: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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協力者と研究者
スポンサー
捜査官
- 主任研究者:Karl Williams, M.D.、Precision Therapeutics, Inc.
出版物と役立つリンク
便利なリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
固形臓器腫瘍の臨床試験
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AstraZeneca募集Adv Solid Malig - H&N SCC、ATM Pro / Def NSCLC、胃がん、乳がん、卵巣がんスペイン, アメリカ, ベルギー, イギリス, フランス, ハンガリー, カナダ, 大韓民国, オーストラリア