Does Intense Regimented Surveillance Improve the Rates of Therapeutic Re-Intervention After Lung Cancer Surgery (Intense-CT)
Does Intense Regimented Surveillance Improve the Rates of Therapeutic Re-Intervention After Lung Cancer Surgery: A Pilot Study for the Intense-CT Trial
After curative lung cancer surgery, there is a risk of recurrence of the primary cancer, or development of a new cancer. Historically, patients who have undergone curative lung cancer surgery have been monitored with chest radiographs (CXR). Unfortunately, 70% of such patients still die of lung cancer. As a result, there has been interest in other methods of surveillance in order to detect recurring or new cancers earlier and have more success in treating them. One such technique is Low Dose Computed Tomography (LDCT), which is currently the standard of care and surveillance at this institution. This pilot study aims to determine whether regimented, intensive, short interval LDCT surveillance leads to higher rates of detection and treatment of recurring lung cancers. The study group will be followed up according to a regimented surveillance program using LDCT. The study group will be compared to a group of historical controls whose follow up after surgery was not standardized, but rather left up to the discretion of the individual surgeon. If the results of this study show improvements in detection and treatment of recurrent cancers, it will allow for a larger trial to study the effects of the LDCT surveillance program on lung cancer survival.
The study question aims to determine whether for survivors after curative surgery for Stage I and Stage II lung cancer, a structured Surveillance Program with Low Dose CT can increase the rate of detection and treatment of recurring or new cancers when compared to historical non-structured surveillance with CXR. This study will also determine if it is warranted to pursue a larger scale randomized controlled trial to further investigate optimal LDCT surveillance follow-up intervals and long-term lung cancer survival.
調査の概要
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
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Ontario
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Hamilton、Ontario、カナダ、L8N 4A6
- St. Joseph's Healthcare Hamilton
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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
説明
Inclusion Criteria:
- Patients must be at minimum 18 years of age
- Patients must have undergone complete resection for pathological Stage I or Stage II lung cancer
- Patients must demonstrate the ability to understand English
- Patients must be able to demonstrate aptitude and willingness to comply with describes study procedures
Exclusion Criteria:
- Patients with residual gross or microscopic disease after surgery
- Patients with pathological Stage III or Stage IV lung cancer
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:非ランダム化
- 介入モデル:並列代入
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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アクティブコンパレータ:LDCT Surveillance Program Group
This cohort will follow a strict schedule of Low Dose Computed Tomography Imaging scans and clinical visits 3, 6, and 12 months after surgery.
At each encounter, a history, physical examination, and review of the LDCT results will be performed.
Patients with normal clinical and imaging findings will proceed to the next scheduled clinical encounter.
Patients with abnormal findings will be managed according to predetermined algorithms.
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他の:Historical Control Group
The control group will be a retrospective cohort taken from 1-year before the implementation of the LDCT surveillance program.
The post-operative follow-up of these participants was not standardized, but rather left up to the discretion of the individual surgeons, and involved chest radiograph imaging as opposed to Low Dose Computed Tomography.
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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 |
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Rate of therapeutic re-intervention within the first year after curative resection of lung cancer
時間枠:One year after surgery
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Defined by: 1) rate of curative intent radiation treatment after detection of recurrent or new primary lung cancer 2) rate of curative intent reoperation after detection of recurrent or new primary lung cancer.
Measured by frequency of events.
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One year after surgery
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Rate of adherence to follow-up visits
時間枠:One year after surgery
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Measured by frequency of events
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One year after surgery
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Morbidity of associated interventions
時間枠:One year after surgery
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Measured by frequency of events
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One year after surgery
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Wael C Hanna, MDCM MBA FRCSC FCCP、McMaster University
研究記録日
主要日程の研究
研究開始 (実際)
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
- SJHH_IntenseCT_Pilot
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?
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。
Low Dose Computed Tomography Imagingの臨床試験
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Emory UniversityNational Cancer Institute (NCI); Blue Earth Diagnostics積極的、募集していない