Health Condition 1: null- Colorectal or Lung (SCLC or NSCLC) cancer Health Condition 2: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung
Conditions
Interventions
None listed
Sponsors
Sanofi Synthelabo India Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Patients with: • colorectal or lung (SCLC or NSCLC) cancer, cytologically or histologically confirmed, • metastatic or locally advanced, • and about to start a new chemotherapy • Age >= 18 years • Written informed consent
Exclusion criteria
Exclusion criteria: Patients on: • Current or anticipated anticoagulant use with exception of use to maintain patency of central venous catheter only. • Life expectancy • Patients participating or planned to be enrolled in clinical trials with blinded study therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢ To establish a risk score model predicting VTE in patients starting new chemotherapy for locally advanced or metastastic cancer (lung or colorectal) at Month-4 â?¢ To assess risk factors for VTE specific to each type of cancer at Month-4 Timepoint: Month 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Incidence of proven VTE (including symptomatic and incidental DVT, PE, catheter thrombosis, visceral thrombosis) â?¢ Arterial thrombosis (ischemic stroke, MI, acute PAD) â?¢ Superficial venous thrombosis â?¢ All Deaths (including VTE-related deaths) â?¢ VTE treatment (prevention, curative) â?¢ Bleeding events and thombocytopenia â?¢ Cancer outcomes (response, stable, progression) Healthcare resources consumption Timepoint: Month 4 | — |
Countries
Bangladesh, Brazil, Canada, Chile, Colombia, Czech Republic, Egypt, France, Germany, Greece, India, Italy, Jordan, Lebanon, Malaysia, Mexico, Morocco, Netherlands, Pakistan, Portugal, Romania, Spain, Thailand, United States of America, Venezuela (Bolivarian Republic of)
Contacts
Public ContactDr Mohit Trivedi
SANOFI SYNTHELABO (I) LTD
Outcome results
None listed