Observational Study of Quality of Live in Patients With Metastatic Pancreatic Cancer (aLIVE)

Celgene

Status: Completed

Conditions: Pancreatic Neoplasms

Treatments: Other: N/A (non-interventional study)

Study type: Observational

Funder types: Industry

Identifiers

NCT02342847

CEL-CPM-2014-01

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

120 participants in 1 patient group

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

Treatment:

Other: N/A (non-interventional study)