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This is a prospective, multicenter, open-label study designed to evaluate the specificity and sensitivity of the Inflammation Based Index (IBI) score as a marker for predicting clinical and radiological response in patients treated with Lu-177 oxodotreotide for inoperable or metastatic, progressive, grade 1 or 2 intestinal neuroendocrine tumors.
This IBI score will be assessed on the basis of C-reactive protein (CRP) and albumin values, and will be defined as follows:
Patients were followed up for 36 months.
A total of 150 patients should be included in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients Treated With Lu-177 Oxodotreotide for Intestinal Neuroendocrine Tumour | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Additional blood tests (CRP and serum albumin) and data collection. | Other | These blood tests will be carried out on several occasions (before, during and after treatment with Lu-177 oxodotreotide). No additional blood sampling is required. In addition, patient clinical data and imaging data (standard examinations: thoraco-abdomino-pelvic CT +/- MRI and Ga-68 DOTA PET-CT) will be specifically collected for study purposes. For IUCT-O patients only: blood samples may be taken (at cycles 1 and 2, then 12 months after inclusion) for bio-banking purposes. |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity, defined as the ratio of the number of refractory patients with an IBI score > 0 to the number of refractory patients. | 12 months for each patient | |
| Specificity, defined as the ratio of the number of non-refractory patients with an IBI score = 0 to the number of non-refractory patients. | 12 months for each patient |
| Measure | Description | Time Frame |
|---|---|---|
| The sensitivity of the IBI score will be presented at different measurement times in a similar way to the primary endpoint. | 36 months for each patient | |
| The specificity of the IBI score will be presented at different measurement times in a similar way to the primary endpoint. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lavinia VIJA | Contact | 05 31 15 56 47 | Vija.Lavinia@iuct-oncopole.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut de Cancérologie de l'Ouest | Not yet recruiting | Angers | 49055 | France |
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|
| 36 months for each patient |
| Clinico-pathological parameters will be presented by group (IBI score=0 vs >0) using standard descriptive statistics. | 36 months for each patient |
| Imaging parameters will be presented by group (IBI score=0 vs >0) using standard descriptive statistics. | 36 months for each patient |
| Progression-free survival (PFS) rates (time from inclusion to progression or death from any cause) will be estimated with their 95% confidence intervals using the Kaplan-Meier method. | 36 months for each patient |
| CHU de Bordeaux | Not yet recruiting | Bordeaux | France |
|
| Centre François Baclesse | Recruiting | Caen | France |
|
| CHU de Lille | Recruiting | Lille | France |
|
| CHU de Lyon | Not yet recruiting | Lyon | France |
|
| Hôpital La Timone | Not yet recruiting | Marseille | France |
|
| CHU Hôtel Dieu | Recruiting | Nantes | France |
|
| CHU de Poitiers | Not yet recruiting | Poitiers | France |
|
| IUCT-O | Recruiting | Toulouse | France |
|
| ID | Term |
|---|---|
| D012709 | Serum Albumin |
| D003625 | Data Collection |
| ID | Term |
|---|---|
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001798 | Blood Proteins |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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