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Trial record 2 of 2 for:    ES 2018-01

Lanreotide 120mg Effectiveness in Subjects With Pancreatic Neuroendocrine Tumours (PanNET) in Routine Clinical Practice. (PanNET)

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ClinicalTrials.gov Identifier: NCT03947762
Recruitment Status : Active, not recruiting
First Posted : May 13, 2019
Last Update Posted : April 12, 2021
Sponsor:
Information provided by (Responsible Party):
Ipsen

Brief Summary:
The purpose of the protocol is to estimate the progression-free survival (PFS) rate in subjects diagnosed with PanNET, according to investigator assessment, at 24 months after treatment initiation with lanreotide 120 mg every 28 days.

Condition or disease
Pancreatic Neuroendocrine Tumor

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Study Type : Observational
Actual Enrollment : 54 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Lanreotide 120 mg Effectiveness in Subjects With Locally Advanced or Metastatic Pancreatic Neuroendocrine Tumours (PanNET) in Routine Clinical Practice
Actual Study Start Date : July 3, 2019
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : April 30, 2021





Primary Outcome Measures :
  1. Progression-free survival (PFS) rate at 24 months [ Time Frame: 24 months ]
    To estimate the progression-free survival (PFS) rate in subjects diagnosed with PanNET, according to investigator assessment.


Secondary Outcome Measures :
  1. Progression-free survival (PFS) rate at 12 months [ Time Frame: 12 months ]
    PFS rate at 12 months after lanreotide treatment initiation according to investigator assessment

  2. Medical tumour-related intervention [ Time Frame: Baseline ]
    Description of the disease history management of subjects with PanNET will be collected by the investigator and recorded in an electronic CRF (eCRF) designed for the study

  3. Time from diagnosis to first therapeutic intervention [ Time Frame: Baseline ]
    Description of the disease history management of subjects with PanNET

  4. Quality of Life (QoL) [ Time Frame: From baseline up to 24 months ]
    To describe the change in Quality of Life (QoL) as assessed by European Organisation for Research and Treatment of Cancer (EORTC) QoL questionnaire for gastrointestinal neuroendocrine tumours (QLQ-GINET21) questionnaires.Where the patient assess experienced symptoms or problems using the scale from 1 to 4. Where 1 represents "not at all" and 4 "very much".

  5. Median time to lanreotide discontinuation [ Time Frame: Up to 24 months ]
  6. Changes of Chromogranin A (CgA) levels [ Time Frame: Every 6 months up to 24 months ]
    Changes in CgA levels between last CgA value prior to lanreotide start (if available) and values at each study visit

  7. Changes of Glycated hemoglobin (HbA1c) levels [ Time Frame: Every 6 months up to 24 months ]
    Changes in HbA1c levels between last HbA1c value prior to lanreotide start (if available) and values at each study visit

  8. Changes of urine 5-Hydroxyindoleacetic Acid (5-HIAA) levels [ Time Frame: Every 6 months up to 24 months ]
    Changes in 5-HIAA levels between last 5-HIAA value prior to lanreotide start (if available) and values at each study visit

  9. Changes of pro-Brain Natriuretic Peptide (proBNP) levels [ Time Frame: Every 6 months up to 24 months ]
    Changes in proBNP levels between last proBNP value prior to lanreotide start (if available) and values at each study visit

  10. Patient satisfaction [ Time Frame: Baseline visit and 12 months ]
    To evaluate patient' satisfaction (TSQM-9 questionnaire) at inclusion visit. Treatment Satisfaction Questionnaire for Medication (TSQM) is an instrument to assess patients' satisfaction with medication, providing scores on four scales - side effects, effectiveness, convenience and global satisfaction. The effectiveness scored as: 1 (extremely dissatisfied) to 7 (extremely satisfied). For the convenience scored as 1(extremely difficult) to 7 (extremely easy).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hospital patients
Criteria

Inclusion Criteria:

  • Subjects aged ≥ 18
  • Subjects diagnosed of functioning or non-functioning PanNET, G1/ G2 (Ki67≤10%) unresectable locally advanced tumour or metastatic disease, who have been treated with lanreotide 120mg every 28 days for at least 3 months and a maximum of 12 months
  • Subject not progressive at inclusion study visit according to investigator assessment, and using as a reference lanreotide initiation
  • Subject with Eastern Cooperative Oncology Group (ECOG) ≤2

Exclusion Criteria:

  • Subject who is participating in an interventional study
  • Pregnant or breast-feeding women
  • Subject who has received any previous therapy for PanNET (such as octreotide LAR, Molecular Targeted Therapy (MTT), Peptide receptor radionuclide therapy (PRRT), chemotherapy, etc.) except short-acting octreotide subcutaneous (SC) used for symptomatic control of functioning tumours

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03947762


Locations
Show Show 46 study locations
Sponsors and Collaborators
Ipsen
Investigators
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Study Director: Ipsen Medical Director Ipsen
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Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT03947762    
Other Study ID Numbers: A-ES-52030-383
IPS-LAN-2018-01 ( Other Identifier: Spanish Drug Agency AEMPS )
First Posted: May 13, 2019    Key Record Dates
Last Update Posted: April 12, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Adenoma, Islet Cell
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Adenoma
Neoplasms, Glandular and Epithelial
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases