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

Acromegaly Clinical Trial

— BackSOM  

Official title:

BackSOM Study: Qualitative Study in Gastro-enteropancreatic Neuroendocrine Tumors (GEP-NETs) and Acromegaly

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06253897
• Other study ID #: CLIN-52030-460
• Status: Recruiting
• Start date: May 29, 2024
• Est. completion date: August 30, 2024

Study information

• Verified date: June 2024
• Source: Ipsen
• Contact: Ipsen Clinical Study Enquiries
• Phone: see e mail
• Email: clinical.trials[@]ipsen.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: August 30, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acromegaly
• Gastro-enteropancreatic Neuroendocrine Tumor
• Intestinal Neoplasms
• Neuroendocrine Tumors
• Pancreatic Neoplasms
• Stomach Neoplasms

Locations

Country	Name	City	State
United States	Pearl IRB	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Qualitative interview: patients' injection experiences and satisfaction with the Ipsen lanreotide syringe and with the Pharmathen lanreotide syringe;	Interview with a duration of 45 minutes.	Up to 6 months after treatment switch
Secondary	Qualitative interview: patients' understanding of the reasons for the switch from the Ipsen lanreotide syringe to the Pharmathen lanreotide syringe	Interview with a duration of 45 minutes.	Up to 6 months after treatment switch
Secondary	Qualitative interview: patients' perceptions of the Pharmathen lanreotide syringe and of the previous Ipsen lanreotide syringe	Interview with a duration of 45 minutes.	Up to 6 months after treatment switch
Secondary	Qualitative interview: patients' preference for the Ipsen lanreotide syringe versus the Pharmathen lanreotide syringe	Interview with a duration of 45 minutes.	Up to 6 months after treatment switch
Secondary	Qualitative interview: experiences that are unique to patients who independently inject	Interview with a duration of 45 minutes.	Up to 6 months after treatment switch
Secondary	Qualitative interview: experiences that are unique to patients between disease indications	Interview with a duration of 45 minutes.	Up to 6 months after treatment switch