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Observational Approach Versus Surgical Intervention for Stones (OASIS)

2026年7月16日 更新者：Children's Hospital of Philadelphia
The aims of the Observational Approach versus Surgical Intervention for Asymptomatic Stone (OASIS) trial are: 1) to determine whether observation compared to upfront surgery results in less healthcare-related life disruption due to kidney stones among children and adults with asymptomatic kidney stones; 2) to identify the groups benefiting the most from each strategy; and 3) to determine the preferences and values informing the choice between observation and upfront surgery.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

A critical barrier to improving the health of the nearly 40 million Americans with kidney stone disease is the weak evidence base supporting the management of individuals with asymptomatic kidney stones. The proposed Observational Approach versus Surgical Intervention for Asymptomatic Stone (OASIS) randomized clinical trial answers the research question of whether observation or upfront surgery results in less life disruption from asymptomatic kidney stones for children and adults. The management options for patients with asymptomatic stones are 1) observation or 2) upfront surgical treatment, both of which are considered safe, part of usual care, widely accessible, and covered by insurance.

OASIS responds to the charge for well-designed Randomized Controlled Trials (RCT) from the Agency for Healthcare Research and Quality (AHRQ) systematic review on kidney stone disease management and ensures patient centeredness by examining outcomes that patients have identified as meaningful.

Intervention

Randomization to either:

  1. Observation is the surveillance of asymptomatic stones with periodic CT, ultrasound, or x-ray, and clinic visits.
  2. Upfront surgery is the planned removal of asymptomatic stones and includes ureteroscopy (URS) and shockwave lithotripsy (SWL), which are routinely used in standard clinical care.

Observational Cohort (Non-Randomized Cohort):

Up to 300 eligible subjects who are willing to consent to data collection but refuse randomization will be enrolled and followed for two years.

Study Design OASIS is a pragmatic randomized controlled superiority trial conducted at approximately 30 sites that participate in Patient Centered Outcomes Research Network (PCORnet). The trial will include an additional observational cohort for eligible subjects who decline randomization.

研究の種類

介入

入学 (推定)

1658

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前：Rebecca D McCune, BS, MS
  • 電話番号：267-909-6030
  • メール：mccuner@chop.edu

研究連絡先のバックアップ

  • 名前：Brian J Augelli, BS
  • 電話番号：609-504-4908
  • メール：augellib@chop.edu

研究場所

  • アメリカ
    • Pennsylvania
      • Philadelphia、Pennsylvania、アメリカ、19104
        • The Children's Hospital of Philadelphia
        • 主任研究者：
          • Gregory E Tasian, MD, MSc, MSCE

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 子
  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria:

  1. Individuals age 6 or older
  2. Diagnosis of kidney stone disease (nephrolithiasis)

  3. Asymptomatic, non-obstructive kidney stones measuring 4 to 10 mm (inclusive)

    • Asymptomatic is defined as the absence of abdominal pain, flank pain, gross hematuria, and nausea and/or vomiting in the last 3 months that in the judgement of the site PI could be attributable to kidney stones.
    • Non-obstructive is defined as a stone in a renal calyx or stones in multiple renal calyces on CT, ultrasound, and/or x-ray obtained within 6 months of screening.
  4. Informed consent and if appropriate, child assent.
  5. Willingness to be randomized to surgery or observation Note: subjects otherwise eligible who decline randomization may be enrolled in a parallel observational cohort.
  6. Fluent in English or Spanish
  7. Willingness to be audio- and/or video- recorded during interviews

Exclusion Criteria:

  1. Untreated hydronephrosis or caliectasis
  2. Pain (e.g., renal colic, abdominal pain) or gross hematuria attributed to kidney stones.
  3. Recurrent symptomatic urinary tract infections (≥3 in 12 months or ≥2 in 6 months). A symptomatic urinary tract infection is defined as having at least one bladder or voiding symptom (e.g., frequency, urgency, dysuria) with bacteriuria (≥105 colony forming units/mL of no more than 2 urinary tract pathogens).
  4. Stone in the renal pelvis, ureter, bladder or urethra
  5. Pregnant females
  6. Solitary kidney, transplant kidney, urinary diversion, medullary sponge kidney
  7. Anatomic abnormality of the kidney (e.g., horseshoe kidney)
  8. Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

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：処理
  • 割り当て：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
アクティブコンパレータ：Non-Randomized (Observational)
手順：Surgery
Upfront surgery is the planned removal of asymptomatic stones and includes ureteroscopy and shockwave lithotripsy, which are routinely used in standard clinical care.
他の：Observation
Observation is the surveillance of asymptomatic stones with periodic CT, ultrasound, or x-ray, and clinic visits.
アクティブコンパレータ：Randomized
手順：Surgery
Upfront surgery is the planned removal of asymptomatic stones and includes ureteroscopy and shockwave lithotripsy, which are routinely used in standard clinical care.
他の：Observation
Observation is the surveillance of asymptomatic stones with periodic CT, ultrasound, or x-ray, and clinic visits.

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
Healthcare-related life disruption
時間枠：Every 3 months (+/- 14 days) from date of consent (observational cohort) or randomization (randomized cohort) until 24 months.
Composite of: Stone-specific emergency department (ED)/urgent care visits, stone-specific hospitalizations and surgery for stones for new symptoms (Shockwave Lithotripsy (SWL) and Ureteroscopy (URS)) as reported via Patient Centered Outcomes Research Network (PCORnet) Common Data Model (CDM) query and participant self-report on REDCap.
Every 3 months (+/- 14 days) from date of consent (observational cohort) or randomization (randomized cohort) until 24 months.

二次結果の測定

結果測定
メジャーの説明
時間枠
Patient reported physical and emotional health (Pain Interference)
時間枠：Every 3 months (+/- 14 days) from date of consent (observational cohort) or randomization (randomized cohort) until 24 months.
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference (PI) is a standardized, self-reported assessment tool developed by the National Institutes of Health (NIH). It measures how much pain hinders a person's physical, mental, social, and recreational activities, as well as their sleep and enjoyment of life. It uses a standardized T-score (average is 50; standard deviation is 10) to reflect the level of disruption. Higher numbers mean more pain interference (pain is having a greater negative impact on your daily life, making it harder to participate in work, social, and physical activities). The study team is using the validated versions for adults (18 years and older at time of consent), children (ages 8-17 years at time of consent), and parent-proxy versions for caregivers of children ages (6-7 years at time of consent). This information will be captured via patient report in REDCap.
Every 3 months (+/- 14 days) from date of consent (observational cohort) or randomization (randomized cohort) until 24 months.
Patient reported physical and emotional health (Anxiety)
時間枠：Every 3 months (+/- 14 days) from date of consent (observational cohort) or randomization (randomized cohort) until 24 months.
Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety is a standardized, self-reported assessment tool developed by the National Institutes of Health (NIH). It measures the severity of fear, worry, dread, hyperarousal, and physical stress symptoms over the past seven days on a 5-point scale (ranging from never to always). Raw scores are converted into a standardized T-score with an average of 50 and a standard deviation of 10. A higher T-score indicates a higher severity of anxiety. The study team is using validated versions for adults (18 years and older at time of consent), children (ages 8-17 years at time of consent), and parent-proxy versions for caregivers of children ages (6-7 years at time of consent). This information will be captured via patient report in REDCap.
Every 3 months (+/- 14 days) from date of consent (observational cohort) or randomization (randomized cohort) until 24 months.
Patient reported physical and emotional health (Stone Quality of Life)
時間枠：Every 3 months (+/- 14 days) from date of consent (observational cohort) or randomization (randomized cohort) until 24 months.
The Wisconsin Stone Quality of Life questionnaire (WISQOL) is a disease-specific health-related quality of life (HRQOL) instrument designed to assess the impact on patients of stones in the urinary tract. Each item is scored on a 5-point Likert scale, yielding a total raw score of 28 to 140. Higher scores reflect a better health-related quality of life. Raw scores are typically converted to a standardized 0-100 scale. This information will be captured via patient report on REDCap.
Every 3 months (+/- 14 days) from date of consent (observational cohort) or randomization (randomized cohort) until 24 months.
Stone passage
時間枠：Every 3 months (+/- 14 days) from date of consent (observational cohort) or randomization (randomized cohort) until 24 months. Reporting total after 2 years.
Patient Reported Survey: Number of self-reported stone passages (A kidney stone episode is passing a stone that caused pain or other bothersome symptoms or having surgery to remove a stone.) This information will be captured via patient report on REDCap.
Every 3 months (+/- 14 days) from date of consent (observational cohort) or randomization (randomized cohort) until 24 months. Reporting total after 2 years.
Lost productivity (Missed School)
時間枠：Every 3 months (+/- 14 days) from date of consent (observational cohort) or randomization (randomized cohort) until 24 months.
Patient Reported Survey: Number of days the patient (for patients under 18 years old at time of consent) missed school due to kidney stones or kidney stone-related care (0 days, 1-2 days, 3-5 days, 6-10 days, more than 10 days) in the last 3 months. This information will be captured via patient report in REDCap.
Every 3 months (+/- 14 days) from date of consent (observational cohort) or randomization (randomized cohort) until 24 months.
Lost productivity (Caregiver Missed Work)
時間枠：Every 3 months (+/- 14 days) from date of consent (observational cohort) or randomization (randomized cohort) until 24 months.
Patient Reported Survey: Number of days the patient's caregiver(s) (for patients <18 years old at time of consent) missed work due to kidney stones or kidney stone-related care (0 days, 1-2 days, 3-5 days, 6-10 days, more than 10 days) in the last 3 months. This information will be captured via patient report on REDCap.
Every 3 months (+/- 14 days) from date of consent (observational cohort) or randomization (randomized cohort) until 24 months.
Lost productivity (Patient Missed Work)
時間枠：Every 3 months (+/- 14 days) from date of consent (observational cohort) or randomization (randomized cohort) until 24 months.
Patient Reported Survey: Number of days the patient missed work (for patients 18 years and older at time of consent) due to kidney stones or kidney stone-related care (0 days, 1-2 days, 3-5 days, 6-10 days, More than 10 days) in the last 3 months. This information will be captured via patient report in REDCap.
Every 3 months (+/- 14 days) from date of consent (observational cohort) or randomization (randomized cohort) until 24 months.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Children's Hospital of Philadelphia

協力者

Patient-Centered Outcomes Research Institute

捜査官

  • 主任研究者：Gregory E Tasian, MD, MSc, MSCE、Children's Hospital of Philadelphia

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年8月1日

一次修了 (推定)

2031年5月31日

研究の完了 (推定)

2032年10月1日

試験登録日

最初に提出

2026年7月16日

QC基準を満たした最初の提出物

2026年7月16日

最初の投稿 (実際)

2026年7月22日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月22日

QC基準を満たした最後の更新が送信されました

2026年7月16日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 26-024242
  • BPS-2025C1-44653 (その他の識別子：Patient-Centered Outcomes Research Institute)

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?

未定

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

いいえ

米国FDA規制機器製品の研究

いいえ

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。

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