- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07635316
A Study of Treatment Patterns and Outcomes in Gastroenteropancreatic Neuroendocrine Tumor (GEP-NET) Patients
1 juli 2026 uppdaterad av: 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.
Studieöversikt
Status
Rekrytering
Betingelser
Studietyp
Observationell
Inskrivning (Beräknad)
4023
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Novartis Pharmaceuticals
- Telefonnummer: +41613241111
- E-post: novartis.email@novartis.com
Studera Kontakt Backup
- Namn: Novartis Pharmaceuticals
Studieorter
-
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New Jersey
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East Hanover, New Jersey, Förenta staterna, 07936
- Rekrytering
- Novartis
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Testmetod
Icke-sannolikhetsprov
Studera befolkning
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.
Beskrivning
Inclusion criteria:
- 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.
- 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.
- Patients ≥18 years of age on the index date
Patients with ≥12 months (360 days) of continuous data availability (proxy for continuous health plan enrollment) prior to the index date, defined as:
- ≥1 medical and pharmacy claim >12 months prior to the index date; AND
- ≥1 medical and pharmacy claim within the first 6 months of the 12-month period prior to the index date; AND
- ≥1 medical and pharmacy claim during the last 6 months of the 12-month period prior to the index date; AND
Patients with ≥1 month (30 days) of continuous data availability (proxy for continuous health plan enrollment) following the index date, defined as:
- ≥ 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
- ≥ 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:
- Patients with evidence of GEP-NET prior to the diagnosis date within the study period
- Patients with evidence of GEP-NET treatment prior to the index date within the study period
- Patients with missing or invalid age or sex
- Patients with other primary malignancies during the 12-month pre-index period
- Patients with invalid death date (i.e., death date ≤ index date)
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
|---|
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Overall GEP-NET Cohort
Adult patients newly diagnosed with a GEP-NET between 01 January 2018 and 31 December 2025.
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1L Lutetium Lu 177 Dotatate Cohort
A subgroup of the Overall GEP-NET Cohort.
Patients receiving 1L lutetium Lu 177 dotatate.
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1L Capecitabine + Temozolomide (CAPTEM) Cohort
A subgroup of the Overall GEP-NET Cohort.
Patients receiving 1L CAPTEM.
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1L Cabozantinib Cohort
A subgroup of the Overall GEP-NET Cohort.
Patients receiving 1L cabozantinib.
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Lutetium Lu 177 Dotatate Cohort
A subgroup of the Overall GEP-NET Cohort.
Patients receiving lutetium Lu 177 dotatate in 2L or later settings.
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CAPTEM Cohort
A subgroup of the Overall GEP-NET Cohort.
Patients receiving CAPTEM in 2L or later settings.
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Cabozantinib Cohort
A subgroup of the Overall GEP-NET Cohort.
Patients receiving cabozantinib in 2L or later settings.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Number of Lines of Therapy (LOTs)
Tidsram: Up to approximately 8 years
|
Up to approximately 8 years
|
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Number and Percentage of Patients by Treatment Regimen per LOT
Tidsram: Up to approximately 8 years
|
Up to approximately 8 years
|
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Number and Percentage of Patients by Type of Therapy in Each LOT
Tidsram: Up to approximately 8 years
|
Up to approximately 8 years
|
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Number and Percentage of Patients who Discontinue all Medications Within the 1L Treatment Regimen
Tidsram: Up to approximately 8 years
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Up to approximately 8 years
|
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Number of Cycles of Medications Within the Treatment Regimen Before Discontinuation
Tidsram: Up to approximately 8 years
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Up to approximately 8 years
|
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Time to 1L Treatment Discontinuation
Tidsram: Up to approximately 8 years
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Up to approximately 8 years
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Ålder
Tidsram: Baslinje
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Baslinje
|
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Duration Between GEP-NET Diagnosis and 1L Treatment
Tidsram: Baseline
|
Baseline
|
|
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Number and Percentage of Patients who Switch Treatment From 1L to Fifth-line (5L) Treatment
Tidsram: Up to approximately 8 years
|
Up to approximately 8 years
|
|
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Number and Percentage of Patients With Addition of Other Therapies While on Initial 1L Therapy
Tidsram: Up to approximately 8 years
|
Up to approximately 8 years
|
|
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Time to Next Treatment (TTNT)
Tidsram: Up to approximately 8 years
|
Up to approximately 8 years
|
|
|
Overall Survival (OS)
Tidsram: Up to approximately 8 years
|
OS calculated as the number of weeks from the start of treatment until death.
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Up to approximately 8 years
|
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Number and Percentage of Patients by Demographics
Tidsram: Baseline
|
Demographics include:
|
Baseline
|
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Duration of Follow-up
Tidsram: Up to approximately 8 years
|
Up to approximately 8 years
|
|
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Number and Percentage of Patients by Clinical Characteristics
Tidsram: Baseline
|
Clinical characteristics include:
|
Baseline
|
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NCI Comorbidity Index Score
Tidsram: 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
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studierektor: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
12 juni 2026
Primärt slutförande (Beräknad)
25 februari 2027
Avslutad studie (Beräknad)
25 februari 2027
Studieregistreringsdatum
Först inskickad
22 maj 2026
Först inskickad som uppfyllde QC-kriterierna
4 juni 2026
Första postat (Faktisk)
9 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
6 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
1 juli 2026
Senast verifierad
1 juli 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CAAA601A1US16
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
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