Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

A Study of Treatment Patterns and Outcomes in Gastroenteropancreatic Neuroendocrine Tumor (GEP-NET) Patients

1 juli 2026 bijgewerkt door: Novartis Pharmaceuticals

Treatment Patterns and Outcomes in GEP NET: A Retrospective Observational Cohort Study (PRIME Initiative)

This study aims to characterize current treatment patterns and clinical outcomes among newly diagnosed GEP-NET patients in the United States using open-source Longitudinal Prescription Claims (LRx) and Patient Centric Medical Claims (Dx) databases supplemented with mortality data.

Studie Overzicht

Toestand

Werving

Conditie

Studietype

Observationeel

Inschrijving (Geschat)

4023

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

  • Naam: Novartis Pharmaceuticals

Studie Locaties

  • Verenigde Staten
    • New Jersey
      • East Hanover, New Jersey, Verenigde Staten, 07936
        • Werving
        • Novartis

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

Patients with evidence of a GEP-NET diagnosis between 01 January 2018 and 31 December 2025 and initiating a 1L treatment during this time period.

Beschrijving

Inclusion criteria:

  1. Patients with ≥1 International Classification of Diseases Clinical Modification, 10th revision (ICD-10-CM) diagnosis code for GEP-NET between 01 January 2018 and 31 December 2025. The date of the first such claim will be defined as the diagnosis date.
  2. Initiation of first-line (1L) systemic therapy (i.e., somatostatin analogs [SSAs], targeted therapy, peptide receptor radionuclide therapy [PRRT], chemotherapy) indicated for GEP-NET on or after the date of diagnosis. The date of treatment initiation will be defined as the index date.
  3. Patients ≥18 years of age on the index date

  4. Patients with ≥12 months (360 days) of continuous data availability (proxy for continuous health plan enrollment) prior to the index date, defined as:

    1. ≥1 medical and pharmacy claim >12 months prior to the index date; AND
    2. ≥1 medical and pharmacy claim within the first 6 months of the 12-month period prior to the index date; AND
    3. ≥1 medical and pharmacy claim during the last 6 months of the 12-month period prior to the index date; AND

  5. Patients with ≥1 month (30 days) of continuous data availability (proxy for continuous health plan enrollment) following the index date, defined as:

    1. ≥ 1 pharmacy dispensing a GEP-NET treatment at any time during the post-index period, including the index date, reports data during the first month following the index date
    2. ≥ 1 provider prescribing a GEP-NET treatment at any time during the post-index period, including the index date, reports data during the first month following the index date

Exclusion criteria:

  1. Patients with evidence of GEP-NET prior to the diagnosis date within the study period
  2. Patients with evidence of GEP-NET treatment prior to the index date within the study period
  3. Patients with missing or invalid age or sex
  4. Patients with other primary malignancies during the 12-month pre-index period
  5. Patients with invalid death date (i.e., death date ≤ index date)

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Overall GEP-NET Cohort
Adult patients newly diagnosed with a GEP-NET between 01 January 2018 and 31 December 2025.
1L Lutetium Lu 177 Dotatate Cohort
A subgroup of the Overall GEP-NET Cohort. Patients receiving 1L lutetium Lu 177 dotatate.
1L Capecitabine + Temozolomide (CAPTEM) Cohort
A subgroup of the Overall GEP-NET Cohort. Patients receiving 1L CAPTEM.
1L Cabozantinib Cohort
A subgroup of the Overall GEP-NET Cohort. Patients receiving 1L cabozantinib.
Lutetium Lu 177 Dotatate Cohort
A subgroup of the Overall GEP-NET Cohort. Patients receiving lutetium Lu 177 dotatate in 2L or later settings.
CAPTEM Cohort
A subgroup of the Overall GEP-NET Cohort. Patients receiving CAPTEM in 2L or later settings.
Cabozantinib Cohort
A subgroup of the Overall GEP-NET Cohort. Patients receiving cabozantinib in 2L or later settings.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Number of Lines of Therapy (LOTs)
Tijdsspanne: Up to approximately 8 years
Up to approximately 8 years
Number and Percentage of Patients by Treatment Regimen per LOT
Tijdsspanne: Up to approximately 8 years
Up to approximately 8 years
Number and Percentage of Patients by Type of Therapy in Each LOT
Tijdsspanne: Up to approximately 8 years
Up to approximately 8 years
Number and Percentage of Patients who Discontinue all Medications Within the 1L Treatment Regimen
Tijdsspanne: Up to approximately 8 years
Up to approximately 8 years
Number of Cycles of Medications Within the Treatment Regimen Before Discontinuation
Tijdsspanne: Up to approximately 8 years
Up to approximately 8 years
Time to 1L Treatment Discontinuation
Tijdsspanne: Up to approximately 8 years
Up to approximately 8 years

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Leeftijd
Tijdsspanne: Basislijn
Basislijn
Duration Between GEP-NET Diagnosis and 1L Treatment
Tijdsspanne: Baseline
Baseline
Number and Percentage of Patients who Switch Treatment From 1L to Fifth-line (5L) Treatment
Tijdsspanne: Up to approximately 8 years
Up to approximately 8 years
Number and Percentage of Patients With Addition of Other Therapies While on Initial 1L Therapy
Tijdsspanne: Up to approximately 8 years
Up to approximately 8 years
Time to Next Treatment (TTNT)
Tijdsspanne: Up to approximately 8 years
Up to approximately 8 years
Overall Survival (OS)
Tijdsspanne: Up to approximately 8 years
OS calculated as the number of weeks from the start of treatment until death.
Up to approximately 8 years
Number and Percentage of Patients by Demographics
Tijdsspanne: Baseline

Demographics include:

  • Age group (18-34, 35-44, 45-54, 55-64, 65+ years)
  • Sex
  • Geographic region
  • Payer type
  • Race/ethnicity
  • Education level
  • Occupation
  • Marital status
Baseline
Duration of Follow-up
Tijdsspanne: Up to approximately 8 years
Up to approximately 8 years
Number and Percentage of Patients by Clinical Characteristics
Tijdsspanne: Baseline

Clinical characteristics include:

  • National Cancer Institute (NCI) comorbidity index category (0, 1, 2, 3+)
  • Comorbidities
  • Treating provider specialty
  • Metastatic sites (bone, visceral, lymph node, liver)
  • Number of distinct metastatic sites (0, 1, 2, 3, 4+)
Baseline
NCI Comorbidity Index Score
Tijdsspanne: Baseline
The NCI comorbidity index is a tool used to measure the risk of non-cancer deaths for cancer patients based on the presence and severity of other health conditions. It includes 14 conditions identified using administrative data diagnosis and procedure codes. The index excludes solid tumors, leukemias, and lymphomas as comorbid conditions. Each condition is assigned a score (from 1 to 6) based on how serious it is and patient scores are summed to give a final overall score. A high score indicates a higher burden of comorbid conditions and possible higher risk of death.
Baseline

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Novartis Pharmaceuticals

Onderzoekers

  • Studie directeur: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

12 juni 2026

Primaire voltooiing (Geschat)

25 februari 2027

Studie voltooiing (Geschat)

25 februari 2027

Studieregistratiedata

Eerst ingediend

22 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

4 juni 2026

Eerst geplaatst (Werkelijk)

9 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

6 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

1 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CAAA601A1US16

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren