Gastroenteropancreatic Neuroendocrine TumorNCT07635316
A Study of Treatment Patterns and Outcomes in Gastroenteropancreatic Neuroendocrine Tumor (GEP-NET) Patients
An observational study of Gastroenteropancreatic Neuroendocrine Tumor, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Gastroenteropancreatic Neuroendocrine Tumor
- How many people
- 4,023 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2026to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Show all 10Show fewer
- ≥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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
United States1 site, 1 recruiting
- Recruiting
Novartis
East Hanover, New Jersey, 07936
About this study
Official title: 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.
- Keywords
- Real-world evidence, Treatment patterns, Lutathera
- Medical subject headings
- Gastro-enteropancreatic neuroendocrine tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Lines of Therapy (LOTs)
Measured: Up to approximately 8 years
Number and Percentage of Patients by Treatment Regimen per LOT
Measured: Up to approximately 8 years
Number and Percentage of Patients by Type of Therapy in Each LOT
Measured: Up to approximately 8 years
Number and Percentage of Patients who Discontinue all Medications Within the 1L Treatment Regimen
Measured: Up to approximately 8 years
Number of Cycles of Medications Within the Treatment Regimen Before Discontinuation
Measured: Up to approximately 8 years
Time to 1L Treatment Discontinuation
Measured: Up to approximately 8 years
Secondary outcomes (10)
Duration Between GEP-NET Diagnosis and 1L Treatment
Measured: Baseline
Number and Percentage of Patients who Switch Treatment From 1L to Fifth-line (5L) Treatment
Measured: Up to approximately 8 years
Number and Percentage of Patients With Addition of Other Therapies While on Initial 1L Therapy
Measured: Up to approximately 8 years
Time to Next Treatment (TTNT)
Measured: Up to approximately 8 years
Overall Survival (OS)
OS calculated as the number of weeks from the start of treatment until death.
Measured: Up to approximately 8 years
Number and Percentage of Patients by Demographics
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
Measured: Baseline
Age
Measured: Baseline
Duration of Follow-up
Measured: Up to approximately 8 years
Number and Percentage of Patients by Clinical Characteristics
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+)
Measured: Baseline
NCI Comorbidity Index Score
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start12 Jun 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroenteropancreatic Neuroendocrine TumorStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 4,023 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07635316
- Sponsor's protocol ID
- CAAA601A1US16
- Status last verified
- Oct 2026
- First submitted
- 22 May 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Patterns and Outcomes in GEP NET: A Retrospective Observational Cohort Study (PRIME Initiative)
- ClinicalTrials.gov ID
- NCT07635316
- Acronym / sponsor ID
- CAAA601A1US16
- Keywords
- Real-world evidence, Treatment patterns, Lutathera
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 4,023 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 12 Jun 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 9 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (10 listed)
- 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:
- Patients with ≥1 month (30 days) of continuous data availability (proxy for continuous health plan enrollment) following the index date, defined as:
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Lines of Therapy (LOTs)
Time frame: Up to approximately 8 years
Number and Percentage of Patients by Treatment Regimen per LOT
Time frame: Up to approximately 8 years
Number and Percentage of Patients by Type of Therapy in Each LOT
Time frame: Up to approximately 8 years
Number and Percentage of Patients who Discontinue all Medications Within the 1L Treatment Regimen
Time frame: Up to approximately 8 years
Number of Cycles of Medications Within the Treatment Regimen Before Discontinuation
Time frame: Up to approximately 8 years
Time to 1L Treatment Discontinuation
Time frame: Up to approximately 8 years
10 secondary outcomes
Duration Between GEP-NET Diagnosis and 1L Treatment
Time frame: Baseline
Number and Percentage of Patients who Switch Treatment From 1L to Fifth-line (5L) Treatment
Time frame: Up to approximately 8 years
Number and Percentage of Patients With Addition of Other Therapies While on Initial 1L Therapy
Time frame: Up to approximately 8 years
Time to Next Treatment (TTNT)
Time frame: Up to approximately 8 years
Overall Survival (OS)
Time frame: Up to approximately 8 years
Number and Percentage of Patients by Demographics
Time frame: Baseline
Age
Time frame: Baseline
Duration of Follow-up
Time frame: Up to approximately 8 years
Number and Percentage of Patients by Clinical Characteristics
Time frame: Baseline
NCI Comorbidity Index Score
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Novartis Pharmaceuticals contact
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroenteropancreatic Neuroendocrine Tumor, run by Novartis Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novartis Pharmaceuticals (+41613241111, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Lines of Therapy (LOTs) (time frame: Up to approximately 8 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.