FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/09/074522 [Registered on: 30/09/2024] Trial Registered Prospectively
Last Modified On: 15/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Detection of deep vein clots in advanced cancer patients with lower limb swelling by bedside Ultrasound screening 
Scientific Title of Study   Prevalence of Deep Vein Thrombosis by bedside Ultrasound screening in advanced cancer patients with Lower limb swelling admitted in Palliative Care Ward - a prospective observational study. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Santhini Chandran  
Designation  DNB first year palliative medicine resident 
Affiliation  Basavatarakam Indo American Cancer Hospital and Research Institute  
Address  Room No 34, Pain And Palliative Medicine, Basavatarakam Indo American Cancer Hospital and Research Institute Road No 10 IAS Officers Quaters Banjara Hills Hyderabad Telangana 500034 8270496325

Hyderabad
TELANGANA
500034
India 
Phone    
Fax    
Email  santhinichandran97@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Praveen kumar kodisharapu 
Designation  Consultant Onco-Anaesthesia, Pain and Palliative Medicine 
Affiliation  Basavatarakam Indo American Cancer Hospital and Research Institute  
Address  Room No 34, Pain And Palliative Medicine, Basavatarakam Indo American Cancer Hospital and Research Institute Road No 10 IAS Officers Quaters Banjara Hills Hyderabad Telangana 500034 9959893915

Hyderabad
TELANGANA
500034
India 
Phone  9959893915  
Fax    
Email  drprawin78@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Praveen kumar kodisharapu 
Designation  Consultant Onco-Anaesthesia, Pain and Palliative Medicine 
Affiliation  Basavatarakam Indo American Cancer Hospital and Research Institute  
Address  Room No 34, Pain And Palliative Medicine, Basavatarakam Indo American Cancer Hospital and Research Institute Road No 10 IAS Officers Quaters Banjara Hills Hyderabad Telangana 500034 9959893915

Hyderabad
TELANGANA
500034
India 
Phone  9959893915  
Fax    
Email  drprawin78@gmail.com  
 
Source of Monetary or Material Support  
Basavatarakam Indo American Cancer Hospital and Research Institute Road No 10 IAS Officers Quaters Banjara Hills Hyderabad Telangana 500034 India 
 
Primary Sponsor  
Name  Basavatarakam Indo-American Cancer Hospital and Research Institute  
Address  Road no 10 IAS Officers Quarters Nandi Nagar Banjara Hills Hyderabad Telangana 500034 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Santhini Chandran   Basavatarakam Indo American Cancer Hospital and Research Institute   Ward 34 Department of Palliative Medicine Road no 10 IAS Officers Quarters Nandi Nagar Banjara Hills Hyderabad Telangana 500034
Hyderabad
TELANGANA 		 8270496325

santhinichandran97@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Basavatarakam Indo American Cancer Hospital and Research Institute Ethical committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C250||Malignant neoplasm of head of pancreas,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patient admitted in Palliative Care Ward
Patient with lower limb edema (bilateral or unilateral)
Patient consented for Ultrasound bedside screening  
 
ExclusionCriteria 
Details  Patient who are previously diagnosed with deep vein thrombosis
Patients who are on anticoagulants
Patient not not consented for bedside Ultrasound screening  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Presence or absence of deep vein thrombosis identified by bedside Ultrasound screening in advanced cancer patients with Lower limb swelling admitted in Palliative Care Ward   At the time of admission in palliative care ward 
 
Secondary Outcome  
Outcome  TimePoints 
To estimate the prevalence of other causes of lower limb swelling in advanced cancer patients  At the time of admission in palliative care ward 
Association of Deep Vein Thrombosis with stage of cancer, type of cancer, performance status, and serum albumin levels  At the time of admission in palliative care ward 
Assessment of symptom burden inpatients with deep vein thrombosis  At the time of admission in palliative care ward  
 
Target Sample Size   Total Sample Size="76"
Sample Size from India="76" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/10/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="11"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   This study is a prospective observational study identifying the prevalence of deep vein thrombosis in advanced cancer patients with lower limb swelling admitted in Palliative Care ward by bedside Ultrasound screening for 12 months. The primary outcome is to determine the presence or absence of deep vein thrombosis in advanced cancer patients with lowerlimb edema with bedside Ultrasound screening.  The secondary objectives include estimation of prevalence of other causes of lower limb swelling in advanced cancer patients, association of Deep Vein Thrombosis with stage of cancer, type of cancer, performance status, and serum albumin levels, and assessment of symptom burden in patients with deep vein thrombosis. 
Close