Softwarové monitorování toxických látek souvisejících s léčbou u pokročilého renálního buněčného karcinomu
Monitorování toxických účinků perorálních cílených látek a imunoterapie u pacientů s pokročilým renálním karcinomem (RCC) pomocí softwaru Carevive, jednoramenné studie proveditelnosti fáze II
Přehled studie
Postavení
Postavení
Podmínky
Podmínky
Intervence / Léčba
Intervence / Léčba
Typ studie
Typ studie
Zápis (Aktuální)
Zápis
Fáze
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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New York
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Rochester, New York, Spojené státy, 14642
- University of Rochester - Wilmot Cancer Institute
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Kritéria účasti
Kritéria způsobilosti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Popis
Kritéria pro zařazení:
- Diagnostika histologicky potvrzeného renálního karcinomu jakéhokoli podtypu s patologickým nebo rentgenovým průkazem metastatického onemocnění
- Věk starší 18 let
- Zúčastněný onkolog Wilmot Cancer Center rozhodl, že kandidát by měl začít buď s perorální cílenou terapií, nebo s imunoterapií pro léčbu pokročilého RCC; to může být pro terapii první linie nebo jakoukoli následnou terapii
- Schopnost poskytnout písemný informovaný souhlas
- Ovládat anglický jazyk a sám se hlásit jako gramotný
- Musíte mít aktivní e-mailovou adresu nebo přístup k chytrému zařízení, na kterém lze přijímat textové zprávy
Kritéria vyloučení:
- Ženy nemohou kojit
- Nemá pravidelný přístup k internetu
- Nemůže docházet do Wilmot Cancer Center na schůzky každé 3-4 měsíce na rutinní návštěvy u svého primárního onkologa
- Subjektům, které byly ve studii dříve, nebude umožněno se znovu zapsat v případě změny léčby
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Počet zbraní
Zbraně a zásahy
Skupina účastníků / ArmSkupina účastníků / Arm |
Intervence / LéčbaIntervence / Léčba |
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Experimentální: Použití softwaru Carevive
Hlášení a řízení vedlejších účinků perorální cílené terapie nebo imunoterapie prostřednictvím softwaru Carevive u pacientů s pokročilým renálním buněčným karcinomem (RCC).
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V této studii Carevive poskytne odkaz na subjekty, aby bylo možné dokončit online průzkum.
Průzkum bude probíhat týdně po dobu prvních 12 týdnů studie a poté bude rozložen na každý další týden.
Otázky se většinou zaměří na vedlejší účinky jejich léčby rakoviny a také na několik otázek o dodržování léků a využívání zdravotní péče.
Po dokončení průzkumu bude subjektu poskytnut plán péče s možnostmi domácí samosprávy pro toxicitu související s drogami.
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Co je měření studie?
Primární výstupní opatření
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Number of Participants Who Submitted at Least One Carevive Survey
Časové okno: From enrollment through 48 weeks
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Number of participants who completed at least one Carevive survey at any time during the 48 week study period.
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From enrollment through 48 weeks
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Percentage of Carevive Surveys Completed Per Participant
Časové okno: From enrollment through 48 weeks
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Percentage of Carevive surveys completed by each participant, calculated as the number of completed surveys divided by the number of surveys prompted by the Carevive software during the 48 week study period.
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From enrollment through 48 weeks
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Number of Participants Who Utilized at Least One Auto-Generated Carevive Care Plan
Časové okno: From enrollment through 48 weeks
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Number of participants who accessed at least one auto-generated Carevive care plan at any time during the 48 week study period.
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From enrollment through 48 weeks
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Percentage of Auto Generated Carevive Care Plans Utilized Per Participant
Časové okno: From enrollment through 48 weeks
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Percentage of auto generated Carevive care plans utilized by each participant, calculated as the number of care plans accessed divided by the total number of care plans generated for that participant during the 48 week study period.
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From enrollment through 48 weeks
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System Usability Scale (SUS) Score for Carevive Software
Časové okno: From enrollment through 48 weeks
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Participants completed the System Usability Scale (SUS), which is a validated 10-item questionnaire that produces a total usability score ranging from 0 to 100.
Scores are categorized into three main categories: excellent (>80.3 points); good (68.0 to 80.3 points) and below average (<68 points).
We calculated the SUS point for each participant who completed the survey.
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From enrollment through 48 weeks
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Sekundární výstupní opatření
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI-DRS) Total Score
Časové okno: From enrollment through 48 weeks
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The FKSI-DRS is a validated patient-reported outcome measure assessing kidney cancer-related symptoms, with total scores ranging from 0 to 36, where higher scores indicate better quality of life.
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From enrollment through 48 weeks
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Distress Level Assessed by NCCN Distress Thermometer
Časové okno: From enrollment through 48 weeks
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The NCCN Distress Thermometer is a validated patient reported outcome measure assessing psychological distress on a scale from 0 to 10, with higher scores indicating greater distress.
Scores were categorized to reflect low distress (0-3) and moderate to severe distress (4-10).
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From enrollment through 48 weeks
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Health Care Utilization Assessment
Časové okno: From enrollment through 48 weeks
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Health care utilization was assessed based on participant self-report and defined as having at least one hospital visit, emergency room visit, or unplanned clinic visit during the 48-week study period.
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From enrollment through 48 weeks
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Participants Reporting Diarrhea
Časové okno: From enrollment through 48 weeks
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Number of participants who self reported Diarrhea (Yes or No) in response to PRO CTCAE survey questions assessing treatment related symptoms from oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Responses were collected using Carevive software surveys administered weekly for the first 12 weeks of the study and then every other week thereafter through 48 weeks.
Participants were counted as reporting this symptom if they answered "Yes" to the corresponding survey question during the specified time period.
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From enrollment through 48 weeks
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Participants Reporting Nausea
Časové okno: From enrollment through 48 weeks
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Number of participants who self reported nausea (Yes or No) in response to PRO CTCAE survey questions assessing treatment related toxicities from oral targeted agents and immunotherapy.
Responses were collected using Carevive surveys administered weekly for the first 12 weeks and then every other week for an additional 36 weeks.
Participants were counted as reporting the symptom if they answered "Yes" to the corresponding survey question during the specified time period.
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From enrollment through 48 weeks
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Participants Reporting Vomiting
Časové okno: From enrollment through 48 weeks
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Number of participants who self reported vomiting (Yes or No) in response to PRO CTCAE survey questions assessing treatment related toxicities from oral targeted agents and immunotherapy.
Responses were collected using Carevive surveys administered weekly for the first 12 weeks and then every other week for an additional 36 weeks.
Participants were counted as reporting the symptom if they answered "Yes" to the corresponding survey question during the specified time period.
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From enrollment through 48 weeks
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Participants Reporting Fatigue
Časové okno: From enrollment through 48 weeks
|
Number of participants who self reported fatigue (Yes or No) in response to PRO CTCAE survey questions assessing treatment related toxicities from oral targeted agents and immunotherapy.
Responses were collected using Carevive surveys administered weekly for the first 12 weeks and then every other week for an additional 36 weeks.
Participants were counted as reporting the symptom if they answered "Yes" to the corresponding survey question during the specified time period.
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From enrollment through 48 weeks
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Participants Reporting Rash
Časové okno: From enrollment through 48 weeks
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Number of participants who self reported rash (Yes or No) in response to PRO CTCAE survey questions assessing treatment related symptoms from oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Responses were collected using Carevive software surveys administered weekly for the first 12 weeks of the study and then every other week thereafter through 48 weeks.
Participants were counted as reporting the symptom if they answered "Yes" to the corresponding survey question during the specified time period.
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From enrollment through 48 weeks
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Participants Reporting Abdominal Pain
Časové okno: From enrollment through 48 weeks
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Number of participants who self reported abdominal pain (Yes or No) in response to PRO CTCAE survey questions assessing treatment related symptoms from oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Responses were collected using Carevive software surveys administered weekly for the first 12 weeks of the study and then every other week thereafter through 48 weeks.
Participants were counted as reporting the symptom if they answered "Yes" to the corresponding survey question during the specified time period.
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From enrollment through 48 weeks
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Participants Reporting Mouth Sores
Časové okno: From enrollment through 48 weeks
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Number of participants who self reported mouth sores (Yes or No) in response to PRO CTCAE survey questions assessing treatment related symptoms from oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Responses were collected using Carevive software surveys administered weekly for the first 12 weeks of the study and then every other week thereafter through 48 weeks.
Participants were counted as reporting the symptom if they answered "Yes" to the corresponding survey question during the specified time period.
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From enrollment through 48 weeks
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Participants Reporting Cough
Časové okno: From enrollment through 48 weeks
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Number of participants who self reported cough (Yes or No) in response to PRO CTCAE survey questions assessing treatment related symptoms from oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Responses were collected using Carevive software surveys administered weekly for the first 12 weeks of the study and then every other week thereafter through 48 weeks.
Participants were counted as reporting the symptom if they answered "Yes" to the corresponding survey question during the specified time period.
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From enrollment through 48 weeks
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Participants Reporting Shortness of Breath
Časové okno: From enrollment through 48 weeks
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Number of participants who self reported Shortness of Breath (Yes or No) in response to PRO CTCAE survey questions assessing treatment related symptoms from oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Responses were collected using Carevive software surveys administered weekly for the first 12 weeks of the study and then every other week thereafter through 48 weeks.
Participants were counted as reporting the symptom if they answered "Yes" to the corresponding survey question during the specified time period.
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From enrollment through 48 weeks
|
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Participants Reporting Anorexia
Časové okno: From enrollment through 48 weeks
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Number of participants who self reported Anorexia (Yes or No) in response to PRO CTCAE survey questions assessing treatment related symptoms from oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Responses were collected using Carevive software surveys administered weekly for the first 12 weeks of the study and then every other week thereafter through 48 weeks.
Participants were counted as reporting this symptom if they answered "Yes" to the corresponding survey question during the specified time period.
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From enrollment through 48 weeks
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Clinician Reported Diarrhea
Časové okno: From enrollment through 48 weeks
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Number of participants with clinician reported diarrhea assessed during in office clinic visits while receiving oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Clinicians recorded the presence or absence of this symptom at baseline and during follow up assessments conducted from enrollment through 48 weeks.
Responses were categorized as Yes, No, or Unknown based on clinician assessment.
These data are presented as longitudinal assessments of symptom occurrence over time.
Summary reporting of these events as adverse events is provided separately in the Adverse Events section.
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From enrollment through 48 weeks
|
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Clinician Reported Nausea
Časové okno: From enrollment through 48 weeks
|
Number of participants with clinician reported nausea assessed during in office clinic visits while receiving oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Clinicians recorded the presence or absence of this symptom at baseline and during follow up assessments conducted from enrollment through 48 weeks.
Responses were categorized as Yes, No, or Unknown based on clinician assessment.
These data are presented as longitudinal assessments of symptom occurrence over time.
Summary reporting of these events as adverse events is provided separately in the Adverse Events section.
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From enrollment through 48 weeks
|
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Clinician Reported Vomiting
Časové okno: From enrollment through 48 weeks
|
Number of participants with clinician reported vomiting assessed during in office clinic visits while receiving oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Clinicians recorded the presence or absence of this symptom at baseline and during follow up assessments conducted from enrollment through 48 weeks.
Responses were categorized as Yes, No, or Unknown based on clinician assessment.
These data are presented as longitudinal assessments of symptom occurrence over time.
Summary reporting of these events as adverse events is provided separately in the Adverse Events section.
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From enrollment through 48 weeks
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Clinician Reported Fatigue
Časové okno: From enrollment through 48 weeks
|
Number of participants with clinician reported fatigue assessed during in office clinic visits while receiving oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Clinicians recorded the presence or absence of this symptom at baseline and during follow up assessments conducted from enrollment through 48 weeks.
Responses were categorized as Yes, No, or Unknown based on clinician assessment.
These data are presented as longitudinal assessments of symptom occurrence over time.
Summary reporting of these events as adverse events is provided separately in the Adverse Events section.
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From enrollment through 48 weeks
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Clinician Reported Rash
Časové okno: From enrollment through 48 weeks
|
Number of participants with clinician reported Rash assessed during in office clinic visits while receiving oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Clinicians recorded the presence or absence of this symptom at baseline and during follow up assessments conducted from enrollment through 48 weeks.
Responses were categorized as Yes, No, or Unknown based on clinician assessment.
These data are presented as longitudinal assessments of symptom occurrence over time.
Summary reporting of these events as adverse events is provided separately in the Adverse Events section.
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From enrollment through 48 weeks
|
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Clinician Reported Abdominal Pain
Časové okno: From enrollment through 48 weeks
|
Number of participants with clinician reported Abdominal Pain assessed during in office clinic visits while receiving oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Clinicians recorded the presence or absence of this symptom at baseline and during follow up assessments conducted from enrollment through 48 weeks.
Responses were categorized as Yes, No, or Unknown based on clinician assessment.
These data are presented as longitudinal assessments of symptom occurrence over time.
Summary reporting of these events as adverse events is provided separately in the Adverse Events section.
|
From enrollment through 48 weeks
|
|
Clinician Reported Mouth Sores
Časové okno: From enrollment through 48 weeks
|
Number of participants with clinician reported Mouth Sores assessed during in office clinic visits while receiving oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Clinicians recorded the presence or absence of this symptom at baseline and during follow up assessments conducted from enrollment through 48 weeks.
Responses were categorized as Yes, No, or Unknown based on clinician assessment.
These data are presented as longitudinal assessments of symptom occurrence over time.
Summary reporting of these events as adverse events is provided separately in the Adverse Events section.
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From enrollment through 48 weeks
|
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Clinician Reported Cough
Časové okno: From enrollment through 48 weeks
|
Number of participants with clinician reported Cough assessed during in office clinic visits while receiving oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Clinicians recorded the presence or absence of this symptom at baseline and during follow up assessments conducted from enrollment through 48 weeks.
Responses were categorized as Yes, No, or Unknown based on clinician assessment.
These data are presented as longitudinal assessments of symptom occurrence over time.
Summary reporting of these events as adverse events is provided separately in the Adverse Events section.
|
From enrollment through 48 weeks
|
|
Clinician Reported Shortness of Breath
Časové okno: From enrollment through 48 weeks
|
Number of participants with clinician reported Shortness of Breath assessed during in office clinic visits while receiving oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Clinicians recorded the presence or absence of this symptom at baseline and during follow up assessments conducted from enrollment through 48 weeks.
Responses were categorized as Yes, No, or Unknown based on clinician assessment.
These data are presented as longitudinal assessments of symptom occurrence over time.
Summary reporting of these events as adverse events is provided separately in the Adverse Events section.
|
From enrollment through 48 weeks
|
|
Clinician Reported Anorexia
Časové okno: From enrollment through 48 weeks
|
Number of participants with clinician reported Anorexia assessed during in office clinic visits while receiving oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Clinicians recorded the presence or absence of this symptom at baseline and during follow up assessments conducted from enrollment through 48 weeks.
Responses were categorized as Yes, No, or Unknown based on clinician assessment.
These data are presented as longitudinal assessments of symptom occurrence over time.
Summary reporting of these events as adverse events is provided separately in the Adverse Events section.
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From enrollment through 48 weeks
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Spolupracovníci a vyšetřovatelé
Sponzor
Sponzor
Spolupracovníci
Spolupracovníci
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Začátek studia
Primární dokončení (Aktuální)
Primární dokončení
Dokončení studie (Aktuální)
Dokončení studie
Termíny zápisu do studia
První předloženo
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
První zveřejněno
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Poslední zveřejněná aktualizace
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Urogenitální onemocnění
- Urogenitální novotvary
- Novotvary podle místa
- Novotvary
- Mužská urogenitální onemocnění
- Onemocnění ledvin
- Urologická onemocnění
- Ženské urogenitální onemocnění
- Ženské urogenitální onemocnění a těhotenské komplikace
- Novotvary podle histologického typu
- Novotvary, žlázové a epiteliální
- Adenokarcinom
- Urologické novotvary
- Novotvary ledvin
- Karcinom
- Karcinom, renální buňka
Další identifikační čísla studie
Další identifikační čísla studie
- UGUK 17036
- UG1CA189961 (Grant/smlouva NIH USA)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
produkt vyrobený a vyvážený z USA
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