Gastro-enteropancreatic Neuroendocrine TumorBackSOMNCT06253897
A Study to Understand Participant's Experiences in Gastro-enteropancreatic Neuroendocrine Tumors (GEP-NETs) and Acromegaly
An observational study of Gastro-enteropancreatic Neuroendocrine Tumor and Acromegaly, run by Ipsen at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastro-enteropancreatic Neuroendocrine Tumor, Acromegaly
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 29 May 2024to 6 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will include adult patients with GEP-NETs and/or acromegaly living in France, Italy, Spain, UK and the USA
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: BackSOM Study: Qualitative Study in Gastro-enteropancreatic Neuroendocrine Tumors (GEP-NETs) and Acromegaly
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.
Read more
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.
- Medical subject headings
- Gastro-enteropancreatic neuroendocrine tumor, Acromegaly
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 6 months after treatment switch
Secondary outcomes (5)
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.
Measured: Up to 6 months after treatment switch
Qualitative interview: patients' perceptions of the Pharmathen lanreotide syringe and of the previous Ipsen lanreotide syringe
Interview with a duration of 45 minutes.
Measured: Up to 6 months after treatment switch
Qualitative interview: patients' preference for the Ipsen lanreotide syringe versus the Pharmathen lanreotide syringe
Interview with a duration of 45 minutes.
Measured: Up to 6 months after treatment switch
Qualitative interview: experiences that are unique to patients who independently inject
Interview with a duration of 45 minutes.
Measured: Up to 6 months after treatment switch
Qualitative interview: experiences that are unique to patients between disease indications
Interview with a duration of 45 minutes.
Measured: Up to 6 months after treatment switch
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start29 May 2024
- Primary completion6 Dec 2024
- Study completion6 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastro-enteropancreatic Neuroendocrine TumorStudies of the same condition, open and under way.
- More trials run by IpsenThe 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
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06253897
- Sponsor's protocol ID
- CLIN-52030-460
- Acronym
- BackSOM
- Status last verified
- Dec 2024
- First submitted
- 2 Feb 2024
- Last updated
- 24 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants. Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BackSOM Study: Qualitative Study in Gastro-enteropancreatic Neuroendocrine Tumors (GEP-NETs) and Acromegaly
- ClinicalTrials.gov ID
- NCT06253897
- Acronym / sponsor ID
- BackSOM / CLIN-52030-460
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- 29 May 2024 (actual)
- Primary completion
- 6 Dec 2024 (actual)
- Study completion
- 6 Dec 2024 (actual)
- First posted
- 12 Feb 2024 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will include adult patients with GEP-NETs and/or acromegaly living in France, Italy, Spain, UK and the USA
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (4 listed)
- 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.
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
Qualitative interview: patients' injection experiences and satisfaction with the Ipsen lanreotide syringe and with the Pharmathen lanreotide syringe;
Time frame: Up to 6 months after treatment switch
Interview with a duration of 45 minutes.
5 secondary outcomes
Qualitative interview: patients' understanding of the reasons for the switch from the Ipsen lanreotide syringe to the Pharmathen lanreotide syringe
Time frame: Up to 6 months after treatment switch
Qualitative interview: patients' perceptions of the Pharmathen lanreotide syringe and of the previous Ipsen lanreotide syringe
Time frame: Up to 6 months after treatment switch
Qualitative interview: patients' preference for the Ipsen lanreotide syringe versus the Pharmathen lanreotide syringe
Time frame: Up to 6 months after treatment switch
Qualitative interview: experiences that are unique to patients who independently inject
Time frame: Up to 6 months after treatment switch
Qualitative interview: experiences that are unique to patients between disease indications
Time frame: Up to 6 months after treatment switch
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2024.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants. Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.
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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. This study is not recruiting at the moment.
Ipsen Medical Director study director
Ipsen
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 Gastro-enteropancreatic Neuroendocrine Tumor and Acromegaly, run by Ipsen 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 8 inclusion and 4 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: finished, as of the sponsor's last update on 24 Dec 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative interview: patients' injection experiences and satisfaction with the Ipsen lanreotide syringe and with the Pharmathen lanreotide syringe; (time frame: Up to 6 months after treatment switch). 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 24 Dec 2024.