Intravenøs og intraperitoneal paclitaxel og oral nilotinib til peritoneal karcinomatose fra ovarie-, kolorektal- eller blindtarmskræft
1. juni 2026 opdateret af: Andrew Blakely, National Cancer Institute (NCI)
Fase II undersøgelse af intravenøs og intraperitoneal paclitaxel og oral nilotinib til peritoneal karcinomatose fra kolorektal, appendiceal, tyndtarm, mave, ovarie eller anden gynækologisk primær cancer
Baggrund:
Tumorer, der har spredt sig til slimhinden i maven fra andre kræftformer, såsom kræft i blindtarmen, tyktarmen eller æggestokkene, kaldes peritoneal carcinomatose. I de fleste tilfælde er resultaterne dårlige. Forskere vil teste en ny behandling.
Objektiv:
For at lære, om kombinationen af oral nilotinib plus paclitaxel givet af IV og direkte ind i maven kan reducere tumorer nok til, at folk kan blive opereret.
Berettigelse:
Voksne på 18 år og ældre med peritoneal carcinomatose, der er for udbredt til operation.
Design:
Deltagerne vil blive screenet med:
Fysisk eksamen
Medicinsk historie
Blod- og urinprøver
Elektrokardiogram
Laparoskopi. De vil få generel anæstesi. Små snit vil blive lavet i deres underliv. Der vil blive udtaget vævs- og væskeprøver.
Undersøgelser om deres helbred
CT-scanninger af deres torso
Deltagerne vil have op til 4 flere laparoskopier. Under den første procedure vil en port blive placeret under huden på deres mave (en IP-port). Det vil blive fastgjort til et kateter, der er placeret i deres mave.
Deltagerne vil få behandling i 3-ugers cyklusser, i 3 eller 6 cyklusser. De vil tage nilotinib gennem munden to gange dagligt. De vil få paclitaxel via IP-port (en gang pr. cyklus) og ved IV (to gange pr. cyklus). Efter cyklus 3 og 6 vil de have en laparoskopi og CT-scanninger. Derefter kan de tage nilotinib og få IV paclitaxel i op til 1 år.
Ved studiebesøg vil deltagerne gentage nogle screeningstest.
Cirka 6 uger efter behandlingens ophør og derefter hver 3. måned i 3 år vil deltagerne have opfølgningsbesøg på NIH eller hos deres lokale læge.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
Baggrund:
- Peritoneal carcinomatose er ensartet dødelig, hvis den ikke behandles; trods fremskridt inden for systemisk kemoterapi, cytoreduktiv kirurgi og intraperitoneal kemoterapi, er overlevelsen fortsat dårlig for størstedelen af patienterne
- Kombinationen af oral nilotinib og intravenøs paclitaxel har vist præklinisk og klinisk synergisme i behandlingen af solide tumorer, med et igangværende fase I-studie på NIH
- Synergien mellem oral nilotinib og intraperitoneal paclitaxel er endnu ikke karakteriseret
- Denne undersøgelse involverer kombinationen af intravenøs og intraperitoneal paclitaxel og oral nilotinib til inoperabel peritoneal carcinomatose fra kolorektal, blindtarm, tyndtarm, gastrisk, ovarie eller andre gynækologiske primære histologier
Objektiv:
- At evaluere effektiviteten af tovejs kemoterapi ved brug af intraperitoneal og intravenøs paclitaxel og oral nilotinib ved at beregne hastigheden af nedskæring af peritoneal sygdomsbyrde for at blive resecerbar, baseret på Peritoneal Carcinomatosis Index (PCI)
Berettigelse:
- Deltagere >= 18 år med histologisk bekræftet ikke-mucinøs peritoneal karcinomatose af kolorektal, appendiceal, tyndtarm, gastrisk, ovarie eller anden gynækologisk primær histologi
- Påvist resistens eller manglende respons på mindst én linje af allerede godkendt og tilgængelig systemisk kemoterapi
- Ingen historie med allergiske reaktioner tilskrevet forbindelser med lignende kemisk eller biologisk sammensætning til at studere lægemidler
- Ingen intraperitoneal kemoterapi inden for de sidste seks måneder
- Anses ude af stand til at gennemgå fuldstændig cytoreduktion
Design:
- Fase II åbent, ikke-randomiseret studie
- Efter bekræftelse af egnethed, på tidspunktet for diagnostisk laparoskopi, vil der blive taget biopsier, og et intraperitonealt kateter vil blive placeret til efterfølgende kemoterapiadministration
- Op til 6 cyklusser vil blive planlagt, med genoptage laparoskopi og biopsier efter cyklus 3 og 6
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
21
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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-
Maryland
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Bethesda, Maryland, Forenede Stater, 20892
- National Institutes of Health Clinical Center
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Beskrivelse
- INKLUSIONSKRITERIER:
For at være berettiget til at deltage i denne undersøgelse skal en person opfylde alle følgende kriterier.
- Histologisk bekræftelse af ikke-mucinøs peritoneal carcinomatose fra kolorektal, blindtarm, tyndtarm, gastrisk, ovarie eller anden gynækologisk (dvs. endometrial, æggeleder, primær peritoneal, cervikal) primær af Laboratory of Pathology, NCI.
- Deltagerne skal have været behandlet med mindst én linje godkendt systemisk kemoterapi med demonstreret resistens eller manglende respons
- Målbar eller evaluerbar sygdom som defineret af RECIST v1.1. kriterier og/eller efter Peritoneal Carcinomatosis Index (PCI)
- Deltagerne skal vurderes til ikke at være kandidater til cytoreduktiv kirurgi, med PCI-score > 30 på screening laparoskopi eller med omfattende serosal involvering af tyndtarmen
- Alder >= 18 år
- ECOG ydeevnestatus <= 2 (Karnofsky >= 60%).
Deltagerne skal have tilstrækkelig organ- og marvfunktion som defineret nedenfor:
- Leukocytter >= 3.000/mcL
- Absolut neutrofiltal >= 1.000/mcL
- Blodplader >= 100.000/mcL
- Total bilirubin inden for <= 1,5x institutionel øvre normalgrænse (ULN)
- AST (SGOT)/ ALT (SGPT) <= 2,5x institutionel ULN
- Serumamylase og lipase <= 1,5x institutionel ULN
- Serumkalium og magnesium større end institutionel nedre normalgrænse
- Kreatinin <= 1,5 mg/dL eller kreatininclearance >= 60 ml/min/1,73 m2 for deltagere med kreatininniveauer over institutionel normal beregnet ved hjælp af eGFR
- Ammende deltager skal acceptere at stoppe amningen.
- Kvinder i den fødedygtige alder skal acceptere at bruge passende prævention (hormonel prævention eller barrieremetode til prævention; abstinens) før studiestart, så længe undersøgelsesdeltagelsen varer og i 90 dage efter sidste undersøgelsesbehandling. Hvis en kvinde har mistanke om, at hun er gravid, mens hun deltager i denne undersøgelse, skal hun straks informere sin behandlende læge.
- Deltagerens evne til at forstå og villighed til at underskrive et skriftligt informeret samtykkedokument.
- Deltagerne skal acceptere samtidig tilmelding til vævsindsamlingsprotokollen 13C0176, tumor, normalt væv og prøver fra patienter, der gennemgår evaluering eller kirurgisk resektion af solide tumorer
EXKLUSIONSKRITERIER:
En person, der opfylder et af følgende kriterier, vil blive udelukket fra deltagelse i denne undersøgelse.
- Deltagere, der modtager andre forsøgsmidler eller har modtaget et forsøgsmiddel inden for 30 dage før starten af undersøgelsesbehandlingen.
- Anamnese med allergiske reaktioner tilskrevet forbindelser med lignende kemisk eller biologisk sammensætning til at studere lægemidler.
- Deltagere, der har modtaget systemisk (dvs. oral eller intravenøs) kemoterapi inden for 5 halveringstider efter det eller de individuelle midler, der blev administreret, eller som har gennemgået større operationer inden for de sidste 12 uger før starten af undersøgelsesbehandlingen.
- Tidligere intraperitoneal kemoterapi inden for de sidste 6 måneder.
- Deltagere, der kræver brug af lægemidler, der vides at forlænge QT-intervallet eller vides at hæmme CYP3A4, 2C8 kraftigt. Deltagere på sådanne midler på screeningstidspunktet er tilladt i undersøgelsen, hvis der kan findes et alternativ, der ikke har de samme farmakokinetiske interaktioner.
- Ukontrolleret interkurrent sygdom, herunder, men ikke begrænset til, igangværende eller aktiv infektion, symptomatisk kongestiv hjertesvigt, ustabil angina pectoris, hjertearytmi eller psykiatrisk sygdom/sociale situationer, der ville begrænse overholdelse af undersøgelseskrav. Bemærk: Intet emne vil blive udelukket baseret på en social situation forud for samråd med Institut for Socialt Arbejde.
- Gravide kvinder er udelukket fra denne undersøgelse.
- Patienter med HIV, som har påviselig viral belastning, eller hvis ART indeholder QTc-forlængende medicin eller CYP3A4-hæmmere uanset viral belastning. (BEMÆRK: Patienter med HIV, som har en upåviselig viral belastning og har været på stabile doser af ART, der ikke forlænger QT-intervallet eller er en stærk CYP3A4, 2C8-hæmmer, er kvalificerede).
- QTcF-interval på >= 450 msek ved studiestart, eller medfødt langt QT-syndrom.
- Mere end 3 liter ascites til stede ved initial laparoskopi, eller historie med mere end to paracentese-procedurer i de 30 dage forud for initial laparoskopi.
- Avanceret leversvigt, som angivet ved Child-Pugh klasse C cirrhose.
- Sensorisk/motorisk neuropati >= Grad 2
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 1/ Intraperitoneal (IP) Catheter Placement and Bidirectional Chemotherapy
Intraperitoneal (IP) and intravenous (IV) paclitaxel administration with oral nilotinib.
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Oral nilotinib vil blive doseret med 300 mg to gange dagligt.
Nilotinib vil blive administreret kontinuerligt fra startdosis (dag -4) frem til laparoskopi #2 og fremefter.
Andre navne:
Paclitaxel: Intraperitoneal (IP) paclitaxel will be dosed at 60 mg/m^2 to be infused over 1 hour on Day 1 of each 3-week cycle; participants with unresectable, but stable or responding disease after C1 through C3 will dose increase IP paclitaxel to 80 mg/m2 for Cycles 4-6.
Intravenous (IV) paclitaxel will be infused over 1 hour on Day 2 of the first week of Cycle 1, followed by Day 1 of the subsequent treatment weeks; IV paclitaxel will be dosed at 60 mg/m2 for Week 1 of Cycle 1 and, if tolerated, at 80 mg/m2 for subsequent treatments.
Andre navne:
Screening, Week -1, Cycle 1 and 4 Day 1 (±3 days at start of cycle), Cycle 2 and 5 Day 1 (±3 days at start of cycle), Cycle 3 and 6 Day 1 (±3 days at start of cycle) and 4-8 Weeks post-therapy (±2 weeks).
Andre navne:
Screening, Cycle 3 and 6 Day 1, Week 6, and every 3 months (± 2 weeks) for up to 3 years total.
Andre navne:
Screening, Day 0, Week -1, and Cycle 3 and 6, Week 3.
Andre navne:
Screening (intra-op), Week -1, Day 0 (intra-op), and on treatment (± 1 day), Cycle 3 and 6, Week 3 (intra-op).
Biopsy only done if deemed eligible per laparoscopy (only performed during laparoscopy).
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Proportion of Participants Who Are Successfully Down Staged to Resectable Based on Peritoneal Carcinomatosis Index (PCI) and Principal Investigator (PI) Discretion Reported Along With a 95% Confidence Interval
Tidsramme: Participants were followed from baseline (within 6 weeks prior to the start of treatment), and every 9 weeks during treatment through study completion for 27 months, 14 days
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We calculated the rate of downstaging of peritoneal disease burden to become resectable based on PCI score of initial and subsequent laparoscopy, or magnetic resonance imaging and/or computed tomography imaging if laparoscopy is not planned.
Disease burden will be considered stable when PCI score at laparoscopy (lap) #3 is < 4 points higher or lower compared to PCI score at lap #2.
Complete Response is PCI≤ 5 with negative histology of at least 3 peritoneal biopsies of suspect nodules and washings with negative cytology.
Partial Response (PR) is at least 4 points decrease in PCI.
Progressive Disease (PD) has at least 4 points increase in PCI.
Stable Disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the PCI.
To document PCI scoring for each participant, the rubric will be completed following each laparoscopy.
The PCI is scaled from 0-39, with higher scores indicating higher disease burden and worse prognosis.
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Participants were followed from baseline (within 6 weeks prior to the start of treatment), and every 9 weeks during treatment through study completion for 27 months, 14 days
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Proportion of Participants Who Are Successfully Down-staged to Resectable by Use of Chemotherapy Reported Along With a 95% Confidence Interval.
Tidsramme: Baseline, every 9 weeks during treatment, and then every 3 months, up to 2 years
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The proportion of participants who are successfully down-staged to resectable by use of chemotherapy will be reported along with a 95% confidence interval.
This outcome measure evaluates how many participants with initially inoperable (unresectable) peritoneal carcinomatosis became eligible for surgery after receiving bidirectional chemotherapy (intravenous and intraperitoneal paclitaxel and oral nilotinib).
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Baseline, every 9 weeks during treatment, and then every 3 months, up to 2 years
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Overall Survival (OS)
Tidsramme: Participants were followed from time of initiation of study treatment to death or last follow-up through study completion for 27 months, 14 days
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OS is defined as the time from the start of treatment until time of death from any cause, for up to 3 years after completion of therapy.
OS will be reported using the Kaplan-Meier method, along with a 95% confidence interval.
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Participants were followed from time of initiation of study treatment to death or last follow-up through study completion for 27 months, 14 days
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Percent Probability of Peritoneal Progression-free Survival (pPFS)
Tidsramme: From baseline, at peritoneal disease relapse from Complete Response (CR) or peritoneal disease progression, and after completion of therapy up to a percent probability of PFS at 12 months
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Percent pPFS will be reported using the Kaplan-Meier method, along with a 95% confidence interval for each histology.
PFS is defined as the duration of time from the start of the treatment until time of peritoneal disease relapse from Complete Response (CR) or peritoneal disease progression, or death, whichever comes first, and after completion of therapy.
Response was assessed by the Peritoneal Carcinomatosis Index (PCI) and the Response Evaluation Criteria in Solid Tumors (RECIST).
Disease relapse is CR is PCI≤ 5 with negative histology of at least 3 peritoneal biopsies of suspect nodules and washings with negative cytology.
Disease progression is at least 4 points increase in PCI.
The appearance of one or more new lesions is also considered progressions.
The Kaplan-Meier method calculates a survival function S(t), which represents the probability of "surviving" (remaining event-free) beyond time t.
It is not calculated directly as a percentage.
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From baseline, at peritoneal disease relapse from Complete Response (CR) or peritoneal disease progression, and after completion of therapy up to a percent probability of PFS at 12 months
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Number of Grades 3, 4, and/or 5 Serious and/or Non-serious Toxicities by Type Assessed Using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Tidsramme: Day-4 through completion of surveillance post-treatment, up to 2 years.
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Safety will be assessed by analyzing the type, grade and frequency of toxicities.
Adverse events (AEs) will be assessed using CTCAE v.5.0.
A non-serious adverse event is any untoward medical occurrence.
A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Grade 1 is mild.
Grade 2 is moderate.
Grade 3 is severe.
Grade 4 is life-threatening.
Grade 5 is death related to adverse event.
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Day-4 through completion of surveillance post-treatment, up to 2 years.
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Participants Quality of Life (QOL) Using the Functional Assessment of Cancer Therapy - Colorectal (FACT-C) Instrument
Tidsramme: Participants were followed from baseline (within 6 weeks prior to start of treatment), and immediately prior to Cycle 3 (one cycle is 21 days) and Cycle 6 and in follow-up, up to 8 weeks post-treatment
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Outcomes from QOL comparing results before to after treatment: Quality of life is assessed using the Functional Assessment of Cancer Therapy - Colorectal (FACT-C) questionnaire, a validated instrument that measures health-related quality of life.
The FACT-C consists of the following subscales: Physical Well-Being (PWB): 7 items; score range 0-28, Social/Family Well-Being (SWB): 7 items; score range 0-28, Emotional Well-Being (EWB): 6 items; score range 0-24, Functional Well-Being (FWB): 7 items; score range 0-28, Colorectal Cancer Subscale (CCS):9 items; score range 0-36.The FACT-C total score is derived by summing all five subscale scores.
Total score range: 0-144.
For all subscales and the total score, higher values represent better quality of life and lower values represent worse quality of life.
Questionnaires are administered at baseline, immediately prior to treatment Cycles 3 and 6, and at follow-up visits.
A single value (average) was calculated for "during treatment immediate
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Participants were followed from baseline (within 6 weeks prior to start of treatment), and immediately prior to Cycle 3 (one cycle is 21 days) and Cycle 6 and in follow-up, up to 8 weeks post-treatment
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Median Peritoneal Progression-free Survival (pPFS)
Tidsramme: Baseline, at peritoneal disease relapse from Complete Response (CR) or peritoneal disease progression, and after completion of therapy, a median of 5.04 months
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Kaplan-Meier method will be used to evaluate peritoneal progression-free survival (pPFS).
Median peritoneal progression-free survival (pPFS) was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) and will be reported along with a 95% two-sided confidence interval.
Progressive Disease is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on available studies.
The appearance of one or more new lesions is also considered progression.
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Baseline, at peritoneal disease relapse from Complete Response (CR) or peritoneal disease progression, and after completion of therapy, a median of 5.04 months
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Percentage of Participants With a Clinicopathologic Response to Therapy by Response Evaluation Criteria in Solid Tumor (RECIST)v 1.1 Reported With a 95% Confidence Interval
Tidsramme: Participants were followed from baseline, every 9 weeks during treatment, and then every 3 months through study completion for 27 months, 14 days
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The percentage of participants with a clinicopathologic response will be reported for all participants along with a 95% confidence interval.
Complete Response (CR) is disappearance of all target lesions.
Any pathological lymph nodes must have reduction in short axis to <10 mm.
Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Progressive Disease (PD) is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on available studies.
In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
The appearance of one or more new lesions is also considered progression.
Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters while on study.
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Participants were followed from baseline, every 9 weeks during treatment, and then every 3 months through study completion for 27 months, 14 days
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Median Overall Survival (OS)
Tidsramme: From time of initiation of study treatment to death or last follow-up, a median of 5.60 months
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Kaplan-Meier method will be used to evaluate median overall OS and will be reported with a 95% confidence interval.
Overall survival (OS) is defined as the time from the start of the treatment until time of death from any cause, for up to 3 years after completion of therapy, assessed every 3 months (±2 weeks).
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From time of initiation of study treatment to death or last follow-up, a median of 5.60 months
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Percentage of Participants Who Become Resectable by Individual Histologies
Tidsramme: Baseline, at peritoneal disease relapse from complete response (CR) or peritoneal disease progression, and after completion of therapy, up to 2 years
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The percentage of participants who become resectable will be evaluated by individual histologies.
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Baseline, at peritoneal disease relapse from complete response (CR) or peritoneal disease progression, and after completion of therapy, up to 2 years
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Participants Quality of Life (QOL) Using the EuroQoL 5-Dimension 5-Level (EQ-5D-5L) Questionnaire
Tidsramme: Participants were followed from baseline (within 6 weeks prior to the start of treatment), during treatment immediately prior to Cycles 3 and 6, and after treatment (Follow-up at 4-8 weeks post-treatment) through study completion for 27 months, 14 days
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Outcomes from QOL using the EuroQoL 5-Dimension 5-Level (EQ-5D-5L) questionnaire comparing results before to after treatment: physical and mental health-related quality of life will be reported.
The EQ-5D-5L questionnaire assesses participants' physical and mental health-related quality of life (QOL).
Questionnaires will be provided to the participants in an electronic application-based format to be filled out at baseline, and immediately prior to Cycles 3 and 6 and in follow-up.
An index score of 100 is considered perfect health with no problems in any dimension.
A score of 0.0 would be dead.
A single value (average) was calculated for "during treatment immediately prior to Cycles 3 and Cycle 6".
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Participants were followed from baseline (within 6 weeks prior to the start of treatment), during treatment immediately prior to Cycles 3 and 6, and after treatment (Follow-up at 4-8 weeks post-treatment) through study completion for 27 months, 14 days
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Clinicopathologic Response to Therapy by Peritoneal Carcinomatosis Index (PCI) Reported for All Participants Along With a 95% Confidence Interval
Tidsramme: Baseline, every 9 weeks during treatment, and then every 3 months for 2 years
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Clinicopathologic response by PCI is reported with a 95% confidence interval.
Complete Response (CR) is PCI ≤ 5 with negative histology of at least 3 peritoneal biopsies of suspect nodules and washings with negative cytology.
Partial Response (PR) is at least 4 points decrease in PCI.
Progressive Disease (PD) is at least 4 points increase in PCI.
The appearance of one or more new lesions is also considered progression.
Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the PCI.
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Baseline, every 9 weeks during treatment, and then every 3 months for 2 years
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)
Tidsramme: Day-4 through completion of surveillance post-treatment, up to 2 years
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Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0).
A non-serious adverse event is any untoward medical occurrence.
A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
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Day-4 through completion of surveillance post-treatment, up to 2 years
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Andrew M Blakely, M.D., National Cancer Institute (NCI)
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
13. oktober 2022
Primær færdiggørelse (Faktiske)
27. januar 2025
Studieafslutning (Faktiske)
27. januar 2025
Datoer for studieregistrering
Først indsendt
8. januar 2022
Først indsendt, der opfyldte QC-kriterier
8. januar 2022
Først opslået (Faktiske)
11. januar 2022
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
25. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
1. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Urogenitale sygdomme
- Genitale sygdomme
- Sygdomme i det endokrine system
- Urogenitale neoplasmer
- Neoplasmer efter sted
- Neoplasmer
- Urogenitale sygdomme hos kvinder
- Kvinders urogenitale sygdomme og graviditetskomplikationer
- Tarmsygdomme
- Neoplasmer efter histologisk type
- Gastrointestinale neoplasmer
- Neoplasmer i fordøjelsessystemet
- Sygdomme i fordøjelsessystemet
- Gastrointestinale sygdomme
- Intestinale neoplasmer
- Endetarmssygdomme
- Kønssygdomme, kvindelige
- Neoplasmer i endokrine kirtler
- Neoplasmer, kirtel og epitel
- Adenocarcinom
- Tyktarmssygdomme
- Ovariesygdomme
- Adnexale sygdomme
- Gonadale lidelser
- Hudsygdomme
- Brystsygdomme
- Karcinom
- Peritoneale sygdomme
- Abdominale neoplasmer
- Cecal neoplasmer
- Cecale sygdomme
- Hud- og bindevævssygdomme
- Kolorektale neoplasmer
- Ovariale neoplasmer
- Brystneoplasmer
- Cholangiocarcinom
- Genitale neoplasmer, kvindelige
- Peritoneale neoplasmer
- Appendiceale neoplasmer
- Organiske kemikalier
- Diagnostiske teknikker og procedurer
- Diagnose
- Kirurgiske procedurer, operative
- Minimalt invasive kirurgiske procedurer
- Kulbrinter
- Cycloparaffiner
- Kulbrinter, alicyklisk
- Kulbrinter, cyklisk
- Terpenes
- Taxoider
- Cyclodecanes
- Diterpenes
- Diagnostiske teknikker, kirurgisk
- Endoskopi
- Diagnostiske teknikker, kardiovaskulær
- Hjertefunktionstest
- Elektrodiagnose
- Paclitaxel
- Nilotinib
- Laparoskopi
- Elektrokardiografi
Andre undersøgelses-id-numre
- 10000237
- 000237-C
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
.Al IPD registreret i journalen vil blive delt med intramurale efterforskere efter anmodning.
@@@@@@Desuden vil alle genomiske sekventeringsdata i stor skala blive delt med abonnenter på dbGaP.
IPD-delingstidsramme
Kliniske data tilgængelige under undersøgelsen og på ubestemt tid.@@@@@@Genomic
data er tilgængelige, når genomiske data er uploadet pr. protokol GDS-plan, så længe databasen er aktiv.
IPD-delingsadgangskriterier
Kliniske data vil blive gjort tilgængelige via abonnement på BTRIS og med tilladelse fra undersøgelsen PI.@@@@@@Genomiske data gøres tilgængelige via dbGaP gennem anmodninger til datadepoterne.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
produkt fremstillet i og eksporteret fra U.S.A.
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .