Clinical trial · Observational
Observational Study of Quality of Live in Patients With Metastatic Pancreatic Cancer
Observational Cohort Study of Health-related Quality of Life in Patients Initiating Treatment With Chemotherapy for Metastatic Pancreatic Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is an observational, post-authorization, prospective follow-up, multi-centre, national study designed to describe the spectrum of health-related quality of life in patients with metastatic pancreatic cancer previously untreated with chemotherapy This study is designed to observe patients treated in routine clinical practice, without the exclusion limitations of a clinical trial. Patients will be enrolled in 7 Spanish sites. In all cases, the decision to treat patients will be performed prior to the decision to include the patient in the study. Given the observational nature of the study, follow-up of patients will be performed according to standard clinical practice of each site.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Neoplasms | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| N/A (non-interventional study) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Pateints with metastatic pancreatic cancer
- description
- Patients diagnosed with metastatic pancreatic cancer confirmed histologically or cytologically, who will be treated with chemotherapy as first-line treatment of metastatic pancreatic cancer. This study is designed to observe patients treated in routine clinical practice, without the exclusion limitations of a clinical trial. The decision to treat patients will be performed prior to the decision to include the patient in the study. The follow-up of patients will be performed according to standard clinical practice of each site
- interventionNames
- Other: N/A (non-interventional study)
Primary outcomes (15)
- measure
- Patients with mild improvement in Quality of life questionnaire - Current standard version 3.0 (EORTC QLQ-C30) scoring
- timeFrame
- Up to 18 months
- description
- Number of participants with mild improvement. Mild improvement in QoL : (increased from ≥ 5 to \<10 points), moderate (increase of between ≥ 10 and \<20 points), and high (increase ≥ 20 points) in EORTC QLQ-C30) scoring.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients aged ≥ 18 years. * Patients diagnosed with metastatic pancreatic cancer confirmed histologically or cytologically * Patients with Karnofsky index ≥ 70 previously untreated with chemotherapy. * Patients with life expectancy ≥ 6 months. * Patients who will be treated with chemotherapy as first-line treatment for metastatic pancreatic cancer.\* * Informed consent in writing or orally before witnesses. * The decision to prescribe any treatment will be clearly dissociated from the patient's inclusion in the study. Therefore, the choice of therapeutic strategy will be made according to usual clinical practice and independently by the doctor before assessing the possible involvement of the patients in the study and their corresponding inclusion in it Exclusion Criteria: * Pregnant or breastfeeding. * Patients who are participating in an interventional clinical trial. * Patients who refuse to participate in this study. * Patients who have no ability to understand and respond to questions related to their health.
References
Publications (0)
Data not yet available