A Study to Understand Participant's Experiences in Gastro-enteropancreatic Neuroendocrine Tumors (GEP-NETs) and Acromegaly

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-29

Study Completion Date

2024-12-06

Brief Summary

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Participants of this study are adults with GEP-NETs and/or acromegaly who were using the Ipsen lanreotide syringe and have transitioned in the last 6 months to the Pharmathen lanreotide syringe, having received at least two injections using the Pharmathen syringe.

GEP-NETs are abnormal growths that develop in the digestive system, including the stomach, intestines, and pancreas. These tumors arise from special cells called neuroendocrine cells, which are found in these organs and release hormones to regulate various bodily functions. GEP-NETs can be slow-growing, and symptoms may vary depending on their location and size.

Acromegaly is a condition where a person's body produces too much growth hormone. This excess hormone can cause certain body parts, like the hands, feet, and face, to enlarge over time. It typically occurs because of a tumor on the pituitary gland in the brain, which is responsible for regulating hormones. Acromegaly can lead to various health issues if not treated, but medications or surgery can often help manage the condition.

Long-acting somatostatin analogs (LA-SSAs) are indicated for patients with Gastroenteropancreatic neuroendocrine tumors (GEP-NETs) and acromegaly who are not eligible for surgery or when surgery fails to achieve remission.

Data for this study will be collected after the treatment switch from the Ipsen lanreotide syringe to the Pharmathen lanreotide syringe has occurred, using one round of one-to-one qualitative telephone and/or videoconference interviews with patients. Interviews will last 45 minutes and be carried out in the local language of the participant's country.

The main aim of this study is to capture the patient experience of the Ipsen lanreotide syringe and their experience with the Pharmathen lanreotide syringe.

Detailed Description

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Conditions

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Gastro-enteropancreatic Neuroendocrine Tumor Acromegaly

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Adult patients;
* Reside in one of the following countries: France, Italy, Spain, UK and the USA;
* Self-report having a clinician-confirmed diagnosis of GEP-NET and/or acromegaly;
* Have transitioned from treatment with the Ipsen lanreotide syringe to the Pharmathen lanreotide syringe within the last six months and have received a minimum of two injections with the Pharmathen lanreotide syringe;
* Had received a minimum of two injections with the Ipsen lanreotide syringe;
* Switched from the Ipsen lanreotide syringe to the Pharmathen lanreotide syringe only once;
* Are currently being treated with the Pharmathen lanreotide syringe;
* Are willing to provide written informed consent prior to data collection.

Exclusion Criteria

* Any comorbid condition or factor that, in the opinion of the participants' recruiter or interviewer, may confound the participant's experience or otherwise interfere with their ability to participate fully in a qualitative interview (e.g., speech impediments);
* Participants who switched from independent-injection with the Ipsen lanreotide syringe to HCP-injection with the Pharmathen lanreotide syringe;
* Participants who switched from HCP-injection with the Ipsen lanreotide syringe to independent-injection with the Pharmathen lanreotide syringe;
* USA participants who independently inject (i.e., injections administered by the patient, a family member or friend) with the Ipsen lanreotide syringe and/or the Pharmathen lanreotide syringe.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ipsen Medical Director

Role: STUDY_DIRECTOR

Ipsen

Locations

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Pearl IRB

Indianapolis, Indiana, United States

Site Status

Countries

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United States

Other Identifiers

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CLIN-52030-460

Identifier Type: -

Identifier Source: org_study_id