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Observational Approach Versus Surgical Intervention for Stones (OASIS)

16 de julho de 2026 atualizado por: 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

1658

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

  • Nome: Rebecca D McCune, BS, MS
  • Número de telefone: 267-909-6030
  • E-mail: mccuner@chop.edu

Estude backup de contato

  • Nome: Brian J Augelli, BS
  • Número de telefone: 609-504-4908
  • E-mail: augellib@chop.edu

Locais de estudo

  • Estados Unidos
    • Pennsylvania
      • Philadelphia, Pennsylvania, Estados Unidos, 19104
        • The Children's Hospital of Philadelphia
        • Investigador principal:
          • Gregory E Tasian, MD, MSc, MSCE

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Filho
  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: Non-Randomized (Observational)
Procedimento: Surgery
Upfront surgery is the planned removal of asymptomatic stones and includes ureteroscopy and shockwave lithotripsy, which are routinely used in standard clinical care.
Outro: Observation
Observation is the surveillance of asymptomatic stones with periodic CT, ultrasound, or x-ray, and clinic visits.
Comparador Ativo: Randomized
Procedimento: Surgery
Upfront surgery is the planned removal of asymptomatic stones and includes ureteroscopy and shockwave lithotripsy, which are routinely used in standard clinical care.
Outro: Observation
Observation is the surveillance of asymptomatic stones with periodic CT, ultrasound, or x-ray, and clinic visits.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Healthcare-related life disruption
Prazo: 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.

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Patient reported physical and emotional health (Pain Interference)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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.

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Children's Hospital of Philadelphia

Colaboradores

Patient-Centered Outcomes Research Institute

Investigadores

  • Investigador principal: Gregory E Tasian, MD, MSc, MSCE, Children's Hospital of Philadelphia

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de agosto de 2026

Conclusão Primária (Estimado)

31 de maio de 2031

Conclusão do estudo (Estimado)

1 de outubro de 2032

Datas de inscrição no estudo

Enviado pela primeira vez

16 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

16 de julho de 2026

Primeira postagem (Real)

22 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

22 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

16 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 26-024242
  • BPS-2025C1-44653 (Outro identificador: Patient-Centered Outcomes Research Institute)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

INDECISO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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