NCT07653126

Brief Summary

The aim of this study was to assess patient characteristics and treatment patterns of gastro-enteropancreatic neuroendocrine tumor (GEP-NET) patients who received PRRT in German routine care.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2023

Shorter than P25 for all trials

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 3, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2023

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

June 12, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 17, 2026

Completed
Last Updated

June 17, 2026

Status Verified

June 1, 2026

Enrollment Period

6 months

First QC Date

June 12, 2026

Last Update Submit

June 12, 2026

Conditions

Keywords

Neuroendocrine TumorsGastroenteropancreatic Neuroendocrine TumorsGEP-NETPeptide Receptor Radionuclide TherapyPRRTLutetium-177177Lu-DOTATATEReal WorldGermany

Outcome Measures

Primary Outcomes (8)

  • Baseline Demographics

    Baseline

  • Number of Patients by Tumor Status

    Baseline

  • Duration Between Initial Diagnosis and Initiation of Primary PRRT

    Baseline

  • Number of Patients by PRRT Line of Therapy

    Approximately 1 year

  • Number of Patients by Type of PRRT Received

    Approximately 1 year

  • PRRT Dosage

    Approximately 1 year

  • Number of Patients by Treatment Interval

    Approximately 1 year

  • Number of Patients by Co-medication

    Approximately 1 year

Study Arms (1)

PRRT Cohort

Adult GEP-NET patients who received PRRT in German routine care.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult GEP-NET patients in Germany who received their first cycle of primary PRRT between 01 July 2020 and 30 June 2021.

You may qualify if:

  • Patients with a confirmed diagnosis of GEP-NET (any localization of the primary tumor including cancer of unknown primary origin \[CUP\], any Grade).
  • Patients with a first cycle of primary PRRT of home-brew 177Lu-DOTATATE/DOTATOC or Lutathera® between 01 July 2020 and 30 June 2021.

You may not qualify if:

  • Received a combination of PRRT with chemotherapy.
  • Received a combination of PRRT with a radionuclide other than lutetium-177 (e.g., yttrium-90).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Novartis Investigative Site

Essen, Germany

Location

Novartis Investigative Site

Heidelberg, Germany

Location

Novartis Investigative Site

München, Germany

Location

Novartis Investigative Site

Rostock, Germany

Location

Novartis Investigative Site

Stuttgart, Germany

Location

Novartis Investigative Site

Tübingen, Germany

Location

Novartis Investigative Site

Würzburg, Germany

Location

MeSH Terms

Conditions

Gastro-enteropancreatic neuroendocrine tumorNeuroendocrine Tumors

Condition Hierarchy (Ancestors)

Neuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve Tissue

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2026

First Posted

June 17, 2026

Study Start

April 3, 2023

Primary Completion

September 29, 2023

Study Completion

September 29, 2023

Last Updated

June 17, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations