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Observational Approach Versus Surgical Intervention for Stones (OASIS)

16 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Stimato)

1658

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Rebecca D McCune, BS, MS
  • Numero di telefono: 267-909-6030
  • Email: mccuner@chop.edu

Backup dei contatti dello studio

  • Nome: Brian J Augelli, BS
  • Numero di telefono: 609-504-4908
  • Email: augellib@chop.edu

Luoghi di studio

  • Stati Uniti
    • Pennsylvania
      • Philadelphia, Pennsylvania, Stati Uniti, 19104
        • The Children's Hospital of Philadelphia
        • Investigatore principale:
          • Gregory E Tasian, MD, MSc, MSCE

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Non-Randomized (Observational)
Procedura: Surgery
Upfront surgery is the planned removal of asymptomatic stones and includes ureteroscopy and shockwave lithotripsy, which are routinely used in standard clinical care.
Altro: Observation
Observation is the surveillance of asymptomatic stones with periodic CT, ultrasound, or x-ray, and clinic visits.
Comparatore attivo: Randomized
Procedura: Surgery
Upfront surgery is the planned removal of asymptomatic stones and includes ureteroscopy and shockwave lithotripsy, which are routinely used in standard clinical care.
Altro: Observation
Observation is the surveillance of asymptomatic stones with periodic CT, ultrasound, or x-ray, and clinic visits.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Healthcare-related life disruption
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Patient reported physical and emotional health (Pain Interference)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Children's Hospital of Philadelphia

Collaboratori

Patient-Centered Outcomes Research Institute

Investigatori

  • Investigatore principale: Gregory E Tasian, MD, MSc, MSCE, Children's Hospital of Philadelphia

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 agosto 2026

Completamento primario (Stimato)

31 maggio 2031

Completamento dello studio (Stimato)

1 ottobre 2032

Date di iscrizione allo studio

Primo inviato

16 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

16 luglio 2026

Primo Inserito (Effettivo)

22 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

22 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

16 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

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

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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