This study is to survey on venous thromboembolism risk in cancer patients (lung or colorectal) who were about to start a new chemotherapy regimen.

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2013/02/003380
• Date of registration: 12-02-2013
• Prospective Registration: No
• Primary sponsor: Sanofi Synthelabo India Ltd
• Public title: This study is to survey on venous thromboembolism risk in cancer patients (lung or colorectal) who were about to start a new chemotherapy regimen.
• Scientific title: A prospective, non-interventional, cohort survey on VTE risk in patients receiving new chemotherapy for cancer - CANTARISK
• Date of first enrolment: 13-09-2011
• Target sample size: 4300
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=4359
• Study type: Observational
• Study design: Other; Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
• Phase: N/A

Countries of recruitment

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

• Name: Dr Mubarak Naqvi
• Affiliation: SANOFI SYNTHELABO (I) LTD

• Name: Dr Mohit Trivedi
• Affiliation: SANOFI SYNTHELABO (I) LTD

Key inclusion & exclusion 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: 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



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Colorectal or Lung (SCLC or NSCLC) cancer Health Condition 2: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung

Primary Outcome(s)

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 Outcome(s)

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

Secondary ID(s)

DIREG_C_04823

Source(s) of Monetary Support

SANOFI SYNTHELABO (I) LTD

Ethics review

Status: Approved
Approval date: 19/08/2011
Contact:

CHL-Apollo Hospitals -Ethics Committee, Indore

Status: Approved
Approval date: 27/08/2011
Contact:

Ethical Review Board Meenakshi Mission Hospital & Research Centre, Madurai

Status: Approved
Approval date: 21/09/2011
Contact:

Institutioinal Ethics Committee, Kuppuswamy Naidu Memorial Hospital, Coimbatore

Status: Approved
Approval date: 27/09/2011
Contact:

Clincal Ethics Forum, Mumbai/SM Karandikar

Status: Approved
Approval date: 27/09/2011
Contact:

Clincal Ethics Forum, Mumbai/Vijay Tuljapurkar

Status: Approved
Approval date: 27/09/2011
Contact:

Clincal Ethics Forum, Mumbai/SS Nirni

Status: Approved
Approval date: 11/10/2011
Contact:

Institutional Review Board, CMC Vellore

Status: Approved
Approval date: 22/11/2011
Contact:

Deenanath Mangeshkar Hospital & Research Centre EC, Pune

Status: Approved
Approval date: 12/01/2012
Contact:

Human Ethics Committee, Regional Cancer Centre , Thiruvananthapuram, Trivandrum, Dr Sajeed

Status: Approved
Approval date: 06/02/2012
Contact:

Human Ethics Committee, Tata Memorial Hospitals, Mumbai