The National CT Colonography Trial (ACRIN6664)
The National CT Colonography Trial: Multicenter Assessment of Accuracy for Detection of Large Adenomas and Cancers in a Healthy Screening Population
RATIONALE: New diagnostic procedures such as computed tomographic colonography may improve the ability to detect colorectal cancer and may provide a less invasive method of detection.
PURPOSE: This clinical trial is studying how well computed tomographic colonography works in screening healthy participants for colorectal cancer.
調査の概要
詳細な説明
OBJECTIVES:
Primary
- Compare the sensitivity of computed tomographic colonography (CTC) vs colonoscopy for detecting significantly large lesions (≥ 10 mm in diameter) in asymptomatic participants, in terms of specificity, area under the ROC curve, and predictive values for detecting clinically significant colorectal neoplasia.
Secondary
- Determine the interobserver variation in accuracy of interpreting CTC examinations of these participants, including any benefits of a primary 3-dimensional read and/or independent second interpretations.
- Determine the effects of different colon preparations on the accuracy of CTC in these participants.
- Compare participant acceptance and willingness to have a repeat examination by CTC vs colonoscopy.
- Determine the accuracy of CTC in detecting flat lesions in the colon of these participants.
OUTLINE: This is a multicenter study.
Participants receive an oral laxative, oral bisacodyl, and three doses of oral barium sulphate 24 hours before imaging. After cathartic cleansing, participants undergo computed tomographic colonography followed by colonoscopy.
Participants are followed up for approximately 4 weeks.
PROJECTED ACCRUAL: A total of 2,607 participants will be accrued for this study.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
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Arizona
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Scottsdale、Arizona、アメリカ、85259-5499
- Mayo Clinic Scottsdale
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California
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La Jolla、California、アメリカ、92093-0658
- Moores UCSD Cancer Center
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Los Angeles、California、アメリカ、90095-1781
- Jonsson Comprehensive Cancer Center at UCLA
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San Francisco、California、アメリカ、94121
- Veterans Affairs Medical Center - San Francisco
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Colorado
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Englewood、Colorado、アメリカ、80112
- Invision/Radiology Imaging Associates - Englewood
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Connecticut
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New Haven、Connecticut、アメリカ、06520-8028
- Yale Cancer Center
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-
Illinois
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Chicago、Illinois、アメリカ、60637-1470
- University of Chicago Cancer Research Center
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Springfield、Illinois、アメリカ、62781
- Clinical Radiologists, S.C. at Memorial Medical Center
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Maryland
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Baltimore、Maryland、アメリカ、21231-2410
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Massachusetts
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Boston、Massachusetts、アメリカ、02215
- Beth Israel Deaconess Medical Center
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-
Minnesota
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Rochester、Minnesota、アメリカ、55905
- Mayo Clinic Cancer Center
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Missouri
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Saint Louis、Missouri、アメリカ、63110
- Mallinckrodt Institute of Radiology at Washington University Medical Center
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Texas
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Houston、Texas、アメリカ、77030-4009
- M.D. Anderson Cancer Center at University of Texas
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Virginia
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Richmond、Virginia、アメリカ、23298-0037
- Virginia Commonwealth University Massey Cancer Center
-
-
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
説明
Inclusion Criteria
- Male or female outpatients
- Aged 50 years or older
- Scheduled for screening colonoscopy
- Participant's signed informed consent
Exclusion Criteria
Symptoms of disease of the lower gastrointestinal tract, including
- Melanotic stools or/and hematochezia on more than one occasion in the previous six months
- Lower abdominal pain that would normally require a medical evaluation
- Inflammatory bowel disease and/or familial polyposis syndrome
- Serious medical conditions that would increase the risk associated with colonoscopy or are so severe that screening would have no benefit
- Pregnancy
- Previous colonoscopy within the past five years
- Anemia (hemoglobin less than 10 gm/dl)
- Positive fecal occult blood test (FOBT)
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
- 主な目的：ふるい分け
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：CT Colonography
CT colonography conducted during the same assessment as colonoscopy.
|
CT colonography performed for comparison with colonoscopy results performed during the same screening assessment.
他の名前：
|
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 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of Participants With Advanced Adenomas (>=10mm) as Determined by Colonoscopy (Per Patient)
時間枠：within 30 days
|
Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard (RS) for determining the existence of advanced adenomas. RS+: Colonoscopy found at least 1 Advanced adenomas >=10mm (as measured at pathology) RS-: No Advanced adenomas >=10mm found by colonoscopy (as measured at pathology) |
within 30 days
|
|
Number of Participants With Advanced Adenomas (>=9mm) Detected by CT Colonoscopy (Per Patient)
時間枠：within 30 days
|
Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard (RS) for determining the existence of advanced adenomas. RS+: Colonoscopy found at least 1 Advanced adenomas >=9mm (as measured at pathology) RS-: No Advanced adenomas >=9mm found by colonoscopy (as measured at pathology) |
within 30 days
|
|
Number of Participants With Advanced Adenomas (>=8mm) Detected by CT Colonoscopy (Per Patient)
時間枠：within 30 days
|
Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard (RS) for determining the existence of advanced adenomas. RS+: Colonoscopy found at least 1 Advanced adenomas >=8mm (as measured at pathology) RS-: No Advanced adenomas >=8mm found by colonoscopy (as measured at pathology) |
within 30 days
|
|
Number of Participants With Advanced Adenomas (>=7mm) Detected by CT Colonoscopy (Per Patient)
時間枠：within 30 days
|
Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard (RS) for determining the existence of advanced adenomas. RS+: Colonoscopy found at least 1 Advanced adenomas >=7mm (as measured at pathology) RS-: No Advanced adenomas >=7mm found by colonoscopy (as measured at pathology) |
within 30 days
|
|
Number of Participants With Advanced Adenomas (>=6mm) Detected by CT Colonoscopy (Per Patient)
時間枠：within 30 days
|
Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard (RS) for determining the existence of advanced adenomas. RS+: Colonoscopy found at least 1 Advanced adenomas >=6mm (as measured at pathology) RS-: No Advanced adenomas >=16mm found by colonoscopy (as measured at pathology) |
within 30 days
|
|
Number of Participants With Advanced Adenomas (>=5mm) Detected by CT Colonoscopy (Per Patient)
時間枠：within 30 days
|
Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard (RS) for determining the existence of advanced adenomas. RS+: Colonoscopy found at least 1 Advanced adenomas >=5mm (as measured at pathology) RS-: No Advanced adenomas >=5mm found by colonoscopy (as measured at pathology) |
within 30 days
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of Advanced Adenoma or Cancer Lesions (>=10mm) Detected by CT Colonoscopy (Per Lesion)
時間枠：within 30 days
|
Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard for determining the existence of advanced adenomas.
CTC lesions needed to be within 2 segments and 50% size of the lesions removed via colonoscopy to be considered "detected"
|
within 30 days
|
|
Number of Advanced Adenoma or Cancer Lesions (>=9mm) Detected by CT Colonoscopy (Per Lesion)
時間枠：within 30 days
|
Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard for determining the existence of advanced adenomas.
CTC lesions needed to be within 2 segments and 50% size of the lesions removed via colonoscopy to be considered "detected"
|
within 30 days
|
|
Number of Advanced Adenoma or Cancer Lesions (>=8mm) Detected by CT Colonoscopy (Per Lesion)
時間枠：within 30 days
|
Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard for determining the existence of advanced adenomas.
CTC lesions needed to be within 2 segments and 50% size of the lesions removed via colonoscopy to be considered "detected"
|
within 30 days
|
|
Number of Advanced Adenoma or Cancer Lesions (>=7mm) Detected by CT Colonoscopy (Per Lesion)
時間枠：within 30 days
|
Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard for determining the existence of advanced adenomas.
CTC lesions needed to be within 2 segments and 50% size of the lesions removed via colonoscopy to be considered "detected"
|
within 30 days
|
|
Number of Advanced Adenoma or Cancer Lesions (>=6mm) Detected by CT Colonoscopy (Per Lesion)
時間枠：within 30 days
|
Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard for determining the existence of advanced adenomas.
CTC lesions needed to be within 2 segments and 50% size of the lesions removed via colonoscopy to be considered "detected"
|
within 30 days
|
|
Number of Advanced Adenoma or Cancer Lesions (>=5mm) Detected by CT Colonoscopy (Per Lesion)
時間枠：within 30 days
|
Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard for determining the existence of advanced adenomas.
CTC lesions needed to be within 2 segments and 50% size of the lesions removed via colonoscopy to be considered "detected"
|
within 30 days
|
|
Interobserver Sensitivity Variability
時間枠：at baseline
|
Evaluate interobserver variability in Sensitivity (P(T+|D+)) and 95% CI) when interpreting CTC examinations Each study was randomly assigned to be read independently using either a primary 2D search method (conventional 2D image display with 3D endoluminal problem solving), or a primary 3D search method (including the capability of displaying multiplanar 2D) and without prior knowledge of the colonoscopy results.
A second trained radiologist of similar skill was assigned to read the images using the other modality Readers were then classified as high performing or not high performing
|
at baseline
|
協力者と研究者
捜査官
- スタディチェア：C. Daniel Johnson, MD、Mayo Clinic
出版物と役立つリンク
一般刊行物
- Vanness DJ, Knudsen AB, Lansdorp-Vogelaar I, Rutter CM, Gareen IF, Herman BA, Kuntz KM, Zauber AG, van Ballegooijen M, Feuer EJ, Chen MH, Johnson CD. Comparative economic evaluation of data from the ACRIN National CT Colonography Trial with three cancer intervention and surveillance modeling network microsimulations. Radiology. 2011 Nov;261(2):487-98. doi: 10.1148/radiol.11102411. Epub 2011 Aug 3.
- Johnson CD, Herman BA, Chen MH, Toledano AY, Heiken JP, Dachman AH, Kuo MD, Menias CO, Siewert B, Cheema JI, Obregon R, Fidler JL, Zimmerman P, Horton KM, Coakley KJ, Iyer RB, Hara AK, Halvorsen RA Jr, Casola G, Yee J, Blevins M, Burgart LJ, Limburg PJ, Gatsonis CA. The National CT Colonography Trial: assessment of accuracy in participants 65 years of age and older. Radiology. 2012 May;263(2):401-8. doi: 10.1148/radiol.12102177. Epub 2012 Feb 23.
- Hara AK, Blevins M, Chen MH, Dachman AH, Kuo MD, Menias CO, Siewert B, Cheema JI, Obregon RG, Fidler JL, Zimmerman P, Horton KM, Coakley KJ, Iyer RB, Halvorsen RA Jr, Casola G, Yee J, Herman BA, Johnson CD. ACRIN CT colonography trial: does reader's preference for primary two-dimensional versus primary three-dimensional interpretation affect performance? Radiology. 2011 May;259(2):435-41. doi: 10.1148/radiol.11100250. Epub 2011 Mar 1.
- Hara AK, Kuo MD, Blevins M, Chen MH, Yee J, Dachman A, Menias CO, Siewert B, Cheema JI, Obregon RG, Fidler JL, Zimmerman P, Horton KM, Coakley K, Iyer RB, Halvorsen RA Jr, Casola G, Johnson CD. National CT colonography trial (ACRIN 6664): comparison of three full-laxative bowel preparations in more than 2500 average-risk patients. AJR Am J Roentgenol. 2011 May;196(5):1076-82. doi: 10.2214/AJR.10.4334.
- Siewert B, Gareen I, Vanness D, et al.: ACRIN 6664: patient acceptance and preferance of CT colonography compared to optical colonoscopy for colon cancer screening. [Abstract] J Clin Oncol 27 (Suppl 15): A-4034, 2009.
- Johnson CD, Chen MH, Toledano AY, Heiken JP, Dachman A, Kuo MD, Menias CO, Siewert B, Cheema JI, Obregon RG, Fidler JL, Zimmerman P, Horton KM, Coakley K, Iyer RB, Hara AK, Halvorsen RA Jr, Casola G, Yee J, Herman BA, Burgart LJ, Limburg PJ. Accuracy of CT colonography for detection of large adenomas and cancers. N Engl J Med. 2008 Sep 18;359(12):1207-17. doi: 10.1056/NEJMoa0800996. Erratum In: N Engl J Med. 2008 Dec 25;359(26):2853.
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 (実際)
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
本研究に関する用語
その他の研究ID番号
- CDR0000367101
- U01CA080098 (米国 NIH グラント/契約)
- U01CA079778 (米国 NIH グラント/契約)
- ACRIN-6664 (その他の識別子：CIP)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
Researchers may request data from the ACRIN data access committee by reviewing the information at:
https://www.acrin.org/RESEARCHERS/POLICIES/DATAANDIMAGESHARINGPOLICY.aspx
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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