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NCT Number: NCT07635316

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

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.

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Key information

Age range

18 year–110 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis

East Hanover, New Jersey, 07936, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Number of Lines of Therapy (LOTs)

    Time frame: Up to approximately 8 years

  2. Number and Percentage of Patients by Treatment Regimen per LOT

    Time frame: Up to approximately 8 years

  3. Number and Percentage of Patients by Type of Therapy in Each LOT

    Time frame: Up to approximately 8 years

  4. Number and Percentage of Patients who Discontinue all Medications Within the 1L Treatment Regimen

    Time frame: Up to approximately 8 years

  5. Number of Cycles of Medications Within the Treatment Regimen Before Discontinuation

    Time frame: Up to approximately 8 years

  6. Time to 1L Treatment Discontinuation

    Time frame: Up to approximately 8 years

Secondary outcomes

  1. Duration Between GEP-NET Diagnosis and 1L Treatment

    Time frame: Baseline

  2. Number and Percentage of Patients who Switch Treatment From 1L to Fifth-line (5L) Treatment

    Time frame: Up to approximately 8 years

  3. Number and Percentage of Patients With Addition of Other Therapies While on Initial 1L Therapy

    Time frame: Up to approximately 8 years

  4. Time to Next Treatment (TTNT)

    Time frame: Up to approximately 8 years

  5. Overall Survival (OS)

    Time frame: Up to approximately 8 years

    OS calculated as the number of weeks from the start of treatment until death.

  6. Number and Percentage of Patients by Demographics

    Time frame: 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
  7. Age

    Time frame: Baseline

  8. Duration of Follow-up

    Time frame: Up to approximately 8 years

  9. Number and Percentage of Patients by Clinical Characteristics

    Time frame: 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+)
  10. NCI Comorbidity Index Score

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Novartis Pharmaceuticals

CONTACT

[email protected]

+41613241111

Novartis Pharmaceuticals

CONTACT

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 9, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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