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Trial record 10 of 34 for:    Lanreotide | Neuroendocrine Tumors

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 : Recruiting
First Posted : May 13, 2019
Last Update Posted : July 25, 2019
Sponsor:
Information provided by (Responsible Party):
Ipsen

Tracking Information
First Submitted Date May 10, 2019
First Posted Date May 13, 2019
Last Update Posted Date July 25, 2019
Actual Study Start Date July 3, 2019
Estimated Primary Completion Date January 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 10, 2019)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03947762 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: May 29, 2019)
  • 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
  • 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 eCRF designed for the study
  • Time from diagnosis to first therapeutic intervention [ Time Frame: Baseline ]
    Description of the disease history management of subjects with PanNET
  • 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".
  • Median time to lanreotide discontinuation [ Time Frame: Up to 24 months ]
  • 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
  • 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
  • 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
  • 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
  • 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).
Original Secondary Outcome Measures
 (submitted: May 10, 2019)
  • 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
  • Medical tumour-related intervention [ Time Frame: Baseline ]
    Description of the disease history management of subjects with PanNET
  • Time from diagnosis to first therapeutic intervention [ Time Frame: Baseline ]
    Description of the disease history management of subjects with PanNET
  • 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".
  • Median time to lanreotide discontinuation [ Time Frame: Up to 24 months ]
  • 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
  • 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
  • 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
  • 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
  • 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).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Lanreotide 120mg Effectiveness in Subjects With Pancreatic Neuroendocrine Tumours (PanNET) in Routine Clinical Practice.
Official Title Lanreotide 120 mg Effectiveness in Subjects With Locally Advanced or Metastatic Pancreatic Neuroendocrine Tumours (PanNET) in Routine Clinical Practice
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Hospital patients
Condition Pancreatic Neuroendocrine Tumor
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 10, 2019)
196
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 31, 2023
Estimated Primary Completion Date January 31, 2023   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Ipsen Recruitment Enquiries clinical.trials@ipsen.com
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT03947762
Other Study ID Numbers A-ES-52030-383
IPS-LAN-2018-01 ( Other Identifier: Spanish Drug Agency AEMPS )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Ipsen
Study Sponsor Ipsen
Collaborators Not Provided
Investigators
Study Director: Ipsen Medical Director Ipsen
PRS Account Ipsen
Verification Date July 2019