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The purpose of this study is to understand how people with neuroendocrine tumors respond to treatment with lanreotide after having received treatment with octreotide.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Data collection | Other | This is a non-interventional study, the decision to prescribe the product would have been taken prior to, and independently from the decision to enrol the patient. |
| Measure | Description | Time Frame |
|---|---|---|
| Response to treatment | Evaluated as responsive disease (i.e., complete response, partial response), stable disease or progressive disease at the last tumor assessment while on treatment with lanreotide (based on tumor imaging, symptoms, biomarker(s) and/or clinical judgement) | 4 months (data collection duration) |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival, after treatment with octreotide | For evaluating progression-free survival events will include radiographic progression per investigator, biomarker progression per investigator, symptom progression per investigator, and death. Adverse events (AEs) will not be considered as an event. | 4 months (data collection duration) |
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Inclusion Criteria:
Exclusion Criteria:
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Hospitals and clinics
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States | ||
| Cancer Center of Kansas |
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| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| ID | Term |
|---|---|
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D003625 | Data Collection |
| ID | Term |
|---|---|
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
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| Duration of response to lanreotide, after treatment with octreotide | For evaluating duration of response events will include radiographic progression per investigator, biomarker progression per investigator, symptom progression per investigator, AEs, and death. Open ended responses will be reviewed during the analysis and determined to be an eligible "event" or not at that time. | 4 months (data collection duration) |
| Duration of treatment with octreotide and duration of treatment with lanreotide | Duration of octreotide treatment assessed as time from start of octreotide treatment to stop of octreotide treatment. Duration of lanreotide treatment assessed as time from lanreotide initiation to end of lanreotide treatment (censored at the date of last administration (+lanreotide frequency) for patients who had ongoing lanreotide treatment). | 4 months (data collection duration) |
| Severity of Adverse Events | Summarized separately during treatment with octreotide and during treatment with lanreotide, as available | 4 months (data collection duration) |
| Reasons for switching from octreotide to lanreotide | Summarized descriptively | 4 months (data collection duration) |
| Levels of 5-hydroxyindoleacetic acid (5-HIAA) (urine test or blood test) before treatment with octreotide, during treatment with octreotide and during treatment with lanreotide, as available | Summarized descriptively | 4 months (data collection duration) |
| Levels of Chromogranin A (CgA) before treatment with octreotide, during treatment with octreotide and during treatment with lanreotide, as available | Summarized descriptively | 4 months (data collection duration) |
| Severity of symptoms (i.e., flushing, diarrhea, dyspnea, abdominal pain, edema, nausea) before treatment with octreotide, during treatment with octreotide, and during treatment with lanreotide, as available | Proportion of patients reporting each symptom | 4 months (data collection duration) |
| Wichita |
| Kansas |
| 67214 |
| United States |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | United States |
| Mercy Medical Center | Baltimore | Maryland | 21202 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| National Transitional Research | East Setauket | New York | 11733 | United States |
| Allegheny Cancer Center | Pittsburgh | Pennsylvania | 15212 | United States |
| D009380 | Neoplasms, Nerve Tissue |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |