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SHAPE-ENDO: Multimodal prækirurgisk optimering hos patienter med fedme og tidligstadiet endometriecancer (SHAPE-ENDO)

6. juni 2026 opdateret af: Jorge García Fernández, Hospital Universitari de Bellvitge

SHAPE-ENDO (Semaglutid + Hormonel Tilgang & Præhabilitering ved Endometriecancer): Prospektiv Observationsstudie for Metabol og Kirurgisk Optimering hos Patienter med Atypisk Endometriel Hyperplasi eller Tidligstadie Endometriecancer og BMI ≥35.

SHAPE-ENDO er et prospektivt observationsstudie udført på Hospital Universitari de Bellvitge, der evaluerer en multimodal prækirurgisk optimeringsstrategi for kvinder med fedme (BMI ≥35) og atypisk endometriehyperplasi eller tidligstadiet endometriecancer. Deltagerne modtager standardbehandlingsinterventioner inklusive semaglutid-terapi, levonorgestrel intrauterint device (med eller uden orale progestiner), struktureret ernærings- og motionsprogrammer samt planlagt endometriesurveillance.

Studiet har til formål at vurdere, om denne multimetode-strategi forbedrer metabolisk sundhed, fremmer vægttab og øger berettigelsen til minimalinvasiv kirurgi, samtidig med at onkologisk sikkerhed opretholdes i optimeringsperioden.

Deltagerne følges i 6-12 måneder med overvågning af antropometriske og metaboliske parametre, histologisk respons, livskvalitet og behandlingsoverholdelse. Alle interventioner er en del af rutinemæssig klinisk pleje. Resultater fra dette studie kan danne grundlag for fremtidige komparative forsøg, der evaluerer metabolske optimeringsstrategier hos patienter med fedme og tidligstadiet endometriecancer.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Fedme er en væsentlig risikofaktor for endometriecancer og er forbundet med øget kirurgisk kompleksitet, perioperativ morbiditet og reduceret berettigelse til minimalt invasiv kirurgi. Hos patienter med svær fedme påvirkes dødeligheden ofte af metaboliske komorbiditeter snarere end cancerprogression. Strategier rettet mod at forbedre metabolisk sundhed og funktionel status før kirurgi kan derfor have vigtige kliniske implikationer.

Hormonbehandlinger såsom levonorgestrel-afgivende intrauterinindretning og systemiske progestiner anvendes almindeligvis til sygdomskontrol hos udvalgte patienter med atypisk endometriehyperplasi eller tidligstadiet endometrioid karcinom. Samtidig har glukagon-lignende peptid-1 receptoragonister, herunder semaglutid, vist signifikant vægttab og kardiometaboliske fordele. Multimodale prehabiliteringstilgange, der kombinerer farmakologisk terapi, ernæringsmæssig optimering og strukturede træningsprogrammer, kan forbedre kirurgisk parathed og generel sundhedsstatus.

SHAPE-ENDO er en prospektiv observationskohortestudie udført på Hospital Universitari de Bellvitge. Studiet evaluerer en multimodal prækirurgisk optimeringsstrategi, der inkluderer farmakologisk vægtstyring med semaglutid, hormonel endometriebehandling med levonorgestrel intrauterinindretning med eller uden orale progestiner, og livsstilsinterventioner inklusive vejledt kostrådgivning og træningsprogrammer. Patienter gennemgår planlagt klinisk opfølgning med metabolisk overvågning, billeddannelse og endometrieprøveudtagning i henhold til rutinemæssig klinisk praksis.

Studiet har til formål at evaluere gennemførligheden og den kliniske indvirkning af denne multimodale optimeringsstrategi hos kvinder med fedme og tidligstadiet endometriesygdom. Resultater inkluderer metaboliske og antropometriske ændringer, histologisk respons, livskvalitet og berettigelse til minimalt invasiv kirurgi. Data indsamles gennem elektroniske patientjournaler, laboratorieprøver, billeddannelsesundersøgelser og validerede patientrapporterede resultatspørgeskemaer. Studiet er godkendt af det institutionelle etikudvalg og involverer kun standardplejeinterventioner.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

80

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

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

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Studiebefolkning

Voksne kvinder med tidligstadiet, lav/mellem-risiko endometrioide endometriecancer eller atypisk hyperplasi/EIN og BMI ≥35 kg/m², som modtager multimodal metabolsk-hormonel prehabilitering før operation.

Beskrivelse

Inklusionskriterier:

  • Kvinder ≥18 år gamle.
  • Histologisk bekræftet atypisk endometriel hyperplasi / EIN eller lavrisiko endometrioide endometriecarcinom (G1-G2), begrænset til livmoderkroppen.
  • Klassificeret som lav/mellem risiko ifølge ESGO-ESTRO-ESP 2025; prækirurgiske stadier IA1, IA2 eller IB.
  • Negativ eller fokal LVSI (hvis tilgængelig).
  • Molekylære undergrupper: POLEmut, p53wt, MMRd eller NSMP ER+.
  • BMI ≥35 kg/m² ved inklusion.
  • Accept af midlertidig konservativ behandling og evne til at følge multimodal optimeringsstrategi.
  • Evne til at forstå og underskrive informeret samtykke.

Eksklusionskriterier:

  • FIGO stadier IA3, IC, II eller højere.
  • Positiv lymfovaskulær invasion.
  • Højrisiko molekylær: p53mut eller NSMP ER-negativ.
  • Ikke-endometrioide histologier (serøs, klar celle, karcinosarkom, blandet, etc.).
  • Metastatisk eller ekstrauterin sygdom.
  • Kontraindikation mod GLP-1RA eller progestogener.
  • Tidligere pankreatitis, MEN-2, medullært thyroideacarcinom.
  • Deltagelse i et andet farmakologisk forsøg.
  • Enhver tilstand, som efter forskerens skøn forringer sikkerhed eller overholdelse.

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: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Arm A - Standard Immediate Surgery

Participants randomized to the control arm will undergo standard immediate surgical treatment according to the institutional protocol of Hospital Universitari de Bellvitge. Surgery will usually include hysterectomy with bilateral salpingo-oophorectomy, sentinel lymph node assessment when indicated and feasible, and minimally invasive or robotic approach whenever technically possible according to clinical judgment.

Intervention: Procedure/Surgery - Standard Immediate Surgery Standard surgical management according to institutional practice for atypical endometrial hyperplasia/endometrial intraepithelial neoplasia or early-stage low-risk endometrioid endometrial cancer. Perioperative outcomes, surgical approach, conversion to laparotomy, estimated blood loss, operative time, hospital stay, transfusion, sentinel lymph node detection, intraoperative complications, and 30-day postoperative complications graded according to Clavien-Dindo will be recorded.
Procedure: Standar upfront Surgery
Standard surgical treatment according to the institutional protocol of Hospital Universitari de Bellvitge for atypical endometrial hyperplasia/endometrial intraepithelial neoplasia or early-stage low-risk endometrioid endometrial cancer. Surgery will usually include hysterectomy with bilateral salpingo-oophorectomy, sentinel lymph node assessment when indicated and feasible, and a minimally invasive or robotic approach whenever technically possible according to clinical judgment. Surgical approach, operative time, estimated blood loss, conversion to laparotomy, transfusion, hospital stay, intraoperative complications, 30-day postoperative complications, readmission, and sentinel lymph node detection will be recorded.
Andre navne:
  • BSO
  • Hysterektomi
  • Standard Surgery
  • Upfront Surgery
Eksperimentel: Arm B - Experimental: SHAPE-ENDO Multimodal Strategy Before Surgery

Participants randomized to the experimental arm will receive the SHAPE-ENDO multimodal pre-surgical optimization strategy before surgery. The strategy includes semaglutide/Wegovy®, levonorgestrel-releasing intrauterine device/Mirena® with or without oral medroxyprogesterone acetate/Progevera®, structured nutritional intervention, adapted physical exercise, and scheduled oncologic surveillance. The strategy will last 28 weeks initially and may be extended up to 54 weeks if there is clinical, metabolic, or anthropometric benefit, adequate tolerance, and no tumor progression.

Intervention: Drug - Semaglutide / Wegovy® Weekly subcutaneous semaglutide administered according to approved labeling, clinical indication, tolerance, and endocrinology assessment, with standard dose escalation up to the tolerated therapeutic dose. Dose, adherence, tolerability, adverse events, and reasons for dose modification or discontinuation will be recorded.

Intervention: Device - Levonorgestrel-Releasing I
Adfærdsmæssigt: Kost- og ernæringsmæssig intervention
Personlig hypokalorisk diætplan overvåget af det kliniske ernæringshold som en del af standard behandling af overvægt og metaboliske tilstande.
Programmet omfatter kaloribegrænsning baseret på basale stofskiftekrav, med mulighed for meget lavkaloriske diæter (VLCD) i 4-6 uger i udvalgte tilfælde.
Opfølgning sker ved regelmæssige ambulante besøg med registrering af vægt, BMI, taljemål og overholdelse.
Denne intervention er en del af rutinemæssig klinisk pleje og tildeles ikke eksperimentelt; resultater registreres prospektivt.
Andre navne:
  • Ernæringsrådgivning
  • Hypokalorisk diætprogram
  • Ernæringsmæssig prehabilitering
Adfærdsmæssigt: Struktureret motions- og præhabiliteringsprogram
Et struktureret fysisk træningsprogram designet til at forbedre funktionel kapacitet, aerob tolerance og kirurgisk formåen. Programmet omfatter overvågede eller semi-overvågede ugentlige sessioner, der kombinerer aerob træning og styrketræning, typisk 3 sessioner om ugen i 30-45 minutter, tilpasset den grundlæggende præstation. Interventionen er en del af rutinemæssig klinisk behandling for patienter med fedme, der gennemgår kirurgisk forberedelse, og tildeles ikke eksperimentelt. Data om overholdelse, tolerance og funktionelle resultater indsamles prospektivt
Andre navne:
  • Træning Præhabilitering
  • Superviseret fysisk aktivitetsprogram
  • Kombineret aerob og styrketræning
Procedure: Endometriel biopsi med eller uden hysteroskopi
Planlagt histologisk overvågning udført ved baseline og ved opfølgende intervaller (typisk 14 og 28-54 uger) for at vurdere lokal tumorstatus, herunder komplet respons, stabilitet eller progression. Procedurene omfatter ambulant endometriebiopsi med valgfri hysteroskopi baseret på klinisk indikation. Disse evalueringer udgør en del af standard klinisk pleje hos patienter, der behandles konservativt for atypisk endometrial hyperplasi eller tidligstadiet endometrioide karcinom, og de tildeles ikke eksperimentelt. Data registreres prospektivt for at vurdere sygdomsudvikling og kirurgisk egnethed.
Andre navne:
  • Hysteroskopi
  • Histologisk Overvågning
  • Endometrieprøvetagning
Procedure: Radiologisk overvågning (MR-scanning og transvaginal ultralydscanning)
Radiologisk evaluering ved brug af bekken-MRI og transvaginal ultralyd udført som en del af den rutinemæssige kliniske pleje for at vurdere livmodersygdom, myometrieinvasion, adnexal status og behandlingsrespons. Billeddannelse udføres typisk ved baseline for at bekræfte stadieinddeling og under opfølgning, når det er klinisk indikeret. Disse billeddannelsesmodaliteter anvendes i henhold til standard kliniske retningslinjer og er ikke tildelt eksperimentelt; resultater indsamles prospektivt for at evaluere sygdomstabilitet og kirurgisk planlægning.
Andre navne:
  • Bækken MR
  • Transvaginal ultralyd
  • Billedovervågning
Medicin: GLP-1 Receptor Agonist
Weekly subcutaneous semaglutide/GLP-1 receptor agonist therapy administered according to approved labeling, clinical indication, patient tolerance, and endocrinology assessment, with standard dose escalation up to the tolerated therapeutic dose. The intervention is used for weight loss and metabolic optimization in participants with severe obesity. Dose, adherence, tolerability, and reasons for dose modification or discontinuation will be recorded prospectively.
Andre navne:
  • Semaglutid
Enhed: Levonorgestrel IUD (Lng-IUD)
Local hormonal therapy using a 52-mg levonorgestrel-releasing intrauterine system placed at baseline or within 14 days after baseline, with ultrasound confirmation of correct placement. The LNG-IUD is used within the protocolized SHAPE-ENDO strategy according to clinical indication, approved labeling, current guidelines, and physician judgment, for local disease control in atypical endometrial hyperplasia/endometrial intraepithelial neoplasia or early-stage, low-risk endometrioid endometrial cancer. Tolerability, continuation, adverse events, and local histological response will be recorded prospectively.
Andre navne:
  • LNG-IUD
Medicin: Oral Progestins
Systemic hormonal therapy prescribed according to clinical criteria to support local disease control in atypical endometrial hyperplasia or early-stage endometrioid carcinoma. Typical regimens include medroxyprogesterone acetate (400-600 mg/day) or megestrol acetate (160-320 mg/day). Therapy is initiated or escalated when indicated based on tumor burden or suboptimal response to LNG-IUD. Oral progestins may be used within the protocolized SHAPE-ENDO strategy according to clinical indication, approved labeling, current guidelines, and physician judgment. Use, dosing, tolerance, and outcomes will be recorded prospectively.
Andre navne:
  • Medroxyprogesteronacetat
  • Megestrolacetat
  • Gestagenbehandling

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Recruitment Rate
Tidsramme: From study opening to end of recruitment, up to 36 months.
Number of participants enrolled per month during the active recruitment period. This outcome will assess the feasibility of recruiting eligible participants with atypical endometrial hyperplasia/endometrial intraepithelial neoplasia or low-risk endometrioid endometrial cancer and BMI ≥40 kg/m² into a pilot randomized clinical trial.
From study opening to end of recruitment, up to 36 months.
Acceptance of Randomization Rate
Tidsramme: At baseline, before randomization.
Proportion of eligible participants who agree to participate in the trial and accept random assignment to either standard immediate surgery or the SHAPE-ENDO multimodal pre-surgical optimization strategy.
At baseline, before randomization.
Participant Retention Rate
Tidsramme: From randomization to surgery and 30 days postoperatively, up to 14 months.
Proportion of randomized participants who complete the planned follow-up required for the main pilot analysis, including surgical treatment and 30-day postoperative assessment, or completion of the assigned intervention period when applicable.
From randomization to surgery and 30 days postoperatively, up to 14 months.
Adherence to the Assigned Intervention
Tidsramme: From randomization to surgery and 30 days postoperatively, up to 14 months.
Proportion of randomized participants who comply with the main procedures planned in their assigned arm. In the control arm, this includes undergoing standard immediate surgery and postoperative follow-up. In the SHAPE-ENDO arm, this includes adherence to the multimodal strategy, scheduled visits, oncologic surveillance, and planned reassessment.
From randomization to surgery and 30 days postoperatively, up to 14 months.
Completion of the SHAPE-ENDO Multimodal Strategy
Tidsramme: From randomization to week 28 or week 54.
Proportion of participants randomized to the SHAPE-ENDO arm who complete the planned multimodal pre-surgical optimization strategy until the week 28 reassessment and, when applicable, until week 54.
From randomization to week 28 or week 54.
Proportion of SHAPE-ENDO Participants Reaching Surgery Without Tumor Progression
Tidsramme: From randomization to surgery, up to 54 weeks.
Proportion of participants randomized to the SHAPE-ENDO arm who undergo surgery after the pre-surgical optimization period without histological, radiological, or clinical evidence of tumor progression.
From randomization to surgery, up to 54 weeks.
Incidence of Serious Adverse Events, Tumor Progression, and Study Discontinuation
Tidsramme: From randomization to surgery and 30 days postoperatively, up to 14 months.
Frequency of serious adverse events, tumor progression during the optimization period, and reasons for discontinuation or withdrawal from the study. Adverse events will be recorded prospectively and classified according to CTCAE v5.0 when applicable. These events will be described overall and by randomized arm when applicable.
From randomization to surgery and 30 days postoperatively, up to 14 months.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Perioperative Morbidity
Tidsramme: At surgery and up to 30 days postoperatively.
Proportion of participants with intraoperative complications and/or clinically relevant postoperative complications within 30 days after surgery, compared between the standard immediate surgery arm and the SHAPE-ENDO arm. Postoperative complications will be classified according to the Clavien-Dindo classification, with clinically relevant complications defined as Clavien-Dindo grade ≥II
At surgery and up to 30 days postoperatively.
Surgical Approach
Tidsramme: At surgery.
Proportion of participants undergoing minimally invasive surgery, robotic surgery, conventional laparoscopy, or laparotomy, compared between the standard immediate surgery arm and the SHAPE-ENDO arm.
At surgery.
Conversion to Laparotomy
Tidsramme: At surgery.
Proportion of participants requiring conversion from minimally invasive surgery to laparotomy, compared between the standard immediate surgery arm and the SHAPE-ENDO arm.
At surgery.
Operative Time
Tidsramme: At surgery.
Duration of surgery measured in minutes, from skin incision to skin closure, compared between the standard immediate surgery arm and the SHAPE-ENDO arm.
At surgery.
Estimated Blood Loss
Tidsramme: At surgery.
Estimated intraoperative blood loss measured in milliliters, compared between the standard immediate surgery arm and the SHAPE-ENDO arm.
At surgery.
Length of Hospital Stay
Tidsramme: From surgery to hospital discharge, up to 30 days.
Number of days from surgery to hospital discharge, compared between the standard immediate surgery arm and the SHAPE-ENDO arm.
From surgery to hospital discharge, up to 30 days.
Need for Blood Transfusion
Tidsramme: At surgery and up to 30 days postoperatively.
Proportion of participants requiring perioperative blood transfusion, compared between the standard immediate surgery arm and the SHAPE-ENDO arm
At surgery and up to 30 days postoperatively.
Sentinel Lymph Node Detection Rate
Tidsramme: At surgery.
Proportion of participants in whom sentinel lymph node mapping is successful, including unilateral and bilateral detection rates when sentinel lymph node assessment is performed. Detection rates will be described and compared between the standard immediate surgery arm and the SHAPE-ENDO arm.
At surgery.
Histological Response in the SHAPE-ENDO Arm
Tidsramme: Baseline to week 14, week 28, and, if applicable, week 54.
Proportion of participants in the SHAPE-ENDO arm with complete response, stable disease, or tumor progression during the pre-surgical optimization period. Complete response is defined as absence of endometrioid carcinoma or atypical hyperplasia in endometrial biopsy. Stable disease is defined as persistence of the lesion without progression in grade or stage. Progression is defined as progression from atypical endometrial hyperplasia/endometrial intraepithelial neoplasia to endometrioid endometrial carcinoma, increase to grade 3, high-risk histology, or extension beyond the uterine corpus.
Baseline to week 14, week 28, and, if applicable, week 54.
Time to Optimization in the SHAPE-ENDO Arm
Tidsramme: From randomization to week 28 or week 54
Time from randomization to multidisciplinary committee decision indicating that sufficient clinical, metabolic, anthropometric, and oncologic optimization has been achieved to proceed to surgery.
From randomization to week 28 or week 54
Rate of Surgery After SHAPE-ENDO Optimization
Tidsramme: From randomization to surgery, up to 54 weeks.
Proportion of participants randomized to the SHAPE-ENDO arm who undergo surgery after the pre-surgical optimization strategy.
From randomization to surgery, up to 54 weeks.
Change in Glycated Hemoglobin
Tidsramme: Baseline to 6 months and baseline to 12 months.
Change from baseline in glycated hemoglobin, measured as HbA1c percentage using standard clinical laboratory assays. Changes over time will be described within each arm and compared between the standard immediate surgery arm and the SHAPE-ENDO arm.
Baseline to 6 months and baseline to 12 months.
Change in Fasting Plasma Glucose
Tidsramme: Baseline to 6 months and baseline to 12 months.
Change from baseline in fasting plasma glucose concentration, measured in mg/dL using standard laboratory assays. Changes over time will be described within each arm and compared between both randomized arms.
Baseline to 6 months and baseline to 12 months.
Change in Insulinemia and HOMA-IR
Tidsramme: Baseline to 6 months and baseline to 12 months.
Change from baseline in fasting insulin concentration and HOMA-IR, when available. Changes over time will be described within each arm and compared between both randomized arms.
Baseline to 6 months and baseline to 12 months.
Change in FIB-4 Index
Tidsramme: Baseline to 6 months and baseline to 12 months.
Change from baseline in fibrosis-4 index, calculated using age, AST, ALT, and platelet count. Changes over time will be described within each arm and compared between both randomized arms.
Baseline to 6 months and baseline to 12 months.
Change in Lipid Profile
Tidsramme: Baseline to 6 months and baseline to 12 months.
Change from baseline in triglycerides, LDL cholesterol, and HDL cholesterol measured using standard laboratory lipid panel testing. Changes over time will be described within each arm and compared between both randomized arms.
Baseline to 6 months and baseline to 12 months.
Change in Blood Pressure
Tidsramme: Baseline to 6 months and baseline to 12 months.
Change from baseline in systolic and diastolic blood pressure, measured in mmHg during scheduled clinical visits. Changes over time will be described within each arm and compared between both randomized arms.
Baseline to 6 months and baseline to 12 months.
Change in C-Reactive Protein
Tidsramme: Baseline to 6 months and baseline to 12 months.
Change from baseline in serum C-reactive protein concentration, measured in mg/L using standard laboratory assays. Changes over time will be described within each arm and compared between both randomized arms.
Baseline to 6 months and baseline to 12 months.
Change in Body Weight and BMI
Tidsramme: Baseline to 6 months and baseline to 12 months.
Absolute and percentage change from baseline in body weight and body mass index. Changes over time will be described within each arm and compared between both randomized arms.
Baseline to 6 months and baseline to 12 months.
Change in Waist Circumference
Tidsramme: Baseline to 6 months and baseline to 12 months.
Change from baseline in waist circumference, measured in centimeters. Changes over time will be described within each arm and compared between both randomized arms.
Baseline to 6 months and baseline to 12 months.
Change in Visceral Adiposity by MRI
Tidsramme: Baseline to week 28 and, if applicable, week 54.
Absolute and percentage change from baseline in visceral adiposity measured by pelvic MRI according to the predefined radiologic measurement protocol. Changes over time will be described within each arm and compared between both randomized arms.
Baseline to week 28 and, if applicable, week 54.
Change in Body Composition by Bioelectrical Impedance Analysis
Tidsramme: Baseline to week 28 and, if applicable, week 54.
Change from baseline in body composition parameters measured by bioelectrical impedance analysis. Changes over time will be described within each arm and compared between both randomized arms.
Baseline to week 28 and, if applicable, week 54.
Change in Health-Related Quality of Life Score - SF-36
Tidsramme: Baseline to 6 months, 12 months, and during long-term follow-up up to 5 years.
Change from baseline in health-related quality of life assessed using the Short Form-36 Health Survey. Scores range from 0 to 100, with higher scores indicating better health-related quality of life. Changes over time will be described within each arm and compared between both randomized arms.
Baseline to 6 months, 12 months, and during long-term follow-up up to 5 years.
Change in Quality of Life Score - EORTC QLQ-C30
Tidsramme: Baseline to 6 months, 12 months, and during long-term follow-up up to 5 years.
Change from baseline in quality of life assessed using the EORTC QLQ-C30 questionnaire. Scores range from 0 to 100 according to EORTC scoring guidelines. Changes over time will be described within each arm and compared between both randomized arms.
Baseline to 6 months, 12 months, and during long-term follow-up up to 5 years.
Overall Survival
Tidsramme: From randomization up to 5 years.
Time from randomization to death from any cause. Participants alive at the end of follow-up will be censored at the date of last contact.
From randomization up to 5 years.
Cancer-Specific Survival
Tidsramme: From randomization up to 5 years.
Time from randomization to death from endometrial cancer. Participants alive or deceased from causes unrelated to endometrial cancer will be censored according to the statistical analysis plan.
From randomization up to 5 years.
Recurrence-Free Survival
Tidsramme: From randomization up to 5 years.
Time from randomization to first documented recurrence of endometrial cancer. Recurrence may be defined by histological, radiological, or clinical evidence according to standard follow-up criteria. Participants without recurrence will be censored at the date of last available follow-up.
From randomization up to 5 years.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Hospital Universitari de Bellvitge

Samarbejdspartnere

University of Barcelona

Efterforskere

  • Ledende efterforsker: Jorge Garcia Fernandez, Hospital Universitari de Bellvitge
  • Ledende efterforsker: Lola Marti, Hospital Universitari de Bellvitge

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.

Generelle publikationer

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 (Anslået)

1. januar 2027

Primær færdiggørelse (Anslået)

1. april 2031

Studieafslutning (Anslået)

1. januar 2035

Datoer for studieregistrering

Først indsendt

23. november 2025

Først indsendt, der opfyldte QC-kriterier

5. marts 2026

Først opslået (Faktiske)

10. marts 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SHAPE-ENDO

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