This study is to survey on venous thromboembolism risk in cancer patients (lung or colorectal) who were about to start a new chemotherapy regimen.
Not Applicable
Completed
- Conditions
- Health Condition 1: null- Colorectal or Lung (SCLC or NSCLC) cancerHealth Condition 2: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung
- Registration Number
- CTRI/2013/02/003380
- Lead Sponsor
- Sanofi Synthelabo India Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 4300
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
Patients on:
•Current or anticipated anticoagulant use with exception of use to maintain patency of central venous catheter only.
•Life expectancy < 4 months
•Patients participating or planned to be enrolled in clinical trials with blinded study therapy
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 <br/ ><br>â?¢To assess risk factors for VTE specific to each type of cancer at Month-4 <br/ ><br>Timepoint: Month 4
- Secondary Outcome Measures
Name Time Method â?¢Incidence of proven VTE (including symptomatic and incidental DVT, PE, catheter thrombosis, visceral thrombosis) <br/ ><br>â?¢Arterial thrombosis (ischemic stroke, MI, acute PAD) <br/ ><br>â?¢Superficial venous thrombosis <br/ ><br>â?¢All Deaths (including VTE-related deaths) <br/ ><br>â?¢VTE treatment (prevention, curative) <br/ ><br>â?¢Bleeding events and thombocytopenia <br/ ><br>â?¢Cancer outcomes (response, stable, progression) <br/ ><br>Healthcare resources consumption <br/ ><br>Timepoint: Month 4