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CTRI Number  CTRI/2015/03/005605 [Registered on: 04/03/2015] Trial Registered Retrospectively
Last Modified On: 02/03/2015
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Epidemiological 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   Effector mechanism anti-cancer response of human granulocytes 
Scientific Title of Study   A study to measure the natural cancer killing activity with the help of cell kill assay (CKA) in human granulocytes and determine effector mechanism of anti-cancer response of human granulocytes 
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 Rajesh Savkur 
Designation  Chief Scientist 
Affiliation  Jehangir Clinical Development Centre 
Address  Jehangir Clinical Development Centre, 5th floor, West Wing Sohrab Hall, Opposite Jehangir Hospital, 32 Sassoon Road, Pune

Pune
MAHARASHTRA
411001
India 
Phone  02026059968  
Fax    
Email  rajesh_savkur@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rajesh Savkur 
Designation  Chief Scientist 
Affiliation  Jehangir Clinical Development Centre 
Address  Jehangir Clinical Development Centre, 5th floor, West Wing Sohrab Hall, Opposite Jehangir Hospital, 32 Sassoon Road, Pune

Pune
MAHARASHTRA
411001
India 
Phone  02026059968  
Fax    
Email  rajesh_savkur@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Rajesh Savkur 
Designation  Chief Scientist 
Affiliation  Jehangir Clinical Development Centre 
Address  Jehangir Clinical Development Centre, 5th floor, West Wing Sohrab Hall, Opposite Jehangir Hospital, 32 Sassoon Road, Pune

Pune
MAHARASHTRA
411001
India 
Phone  02026059968  
Fax    
Email  rajesh_savkur@yahoo.com  
 
Source of Monetary or Material Support  
Munogenics Inc., USA 
 
Primary Sponsor  
Name  Munogenics Inc 
Address  12732 Serafy Court Austin, Texas 78753 , USA Tel: (512) 990-1235 Fax: (512) 990-1131  
Type of Sponsor  Research institution 
 
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 Rajesh Savkur  Jehangir Clinical Development Center  5th Floor Sohrab Hall West wing Saassoon Road
Pune
MAHARASHTRA 		 02026059968

rajesh_savkur@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JCDC Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Human Volunteers 
Patients  Cancer patients at any stage.,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Blood test for cell kill assay and effector mechanisms of granulocytes  This study will be an epidemiological study. All the subjects will have two visits. During screening, the subjects will undergo CKA 1 testing. Repeat sampling will be done after 2 weeks + 7 days to do CKA 2 and other tests as per the protocol.  
Comparator Agent  Nil  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Inclusion:
-Age between 18 and 40 years.
-Must be willing to undergo the CKA test and sign a written Informed consent document.
-Normal healthy volunteers (Pulse – between 50 and 100 / minute with no irregularities, Blood Pressure – Systolic 100- 180 mm Hg and Diastolic 50- 100 mm Hg, oral temperature not exceeding 37.50C, body weight –not less than 45 kg)
-Should be in a healthy state of mind and body.

For cancer patients
-Male and female cancer patients >18 years of age with histologically or cytologically confirmed solid malignant tumors and willing to sign a written informed consent
document.

 
 
ExclusionCriteria 
Details  Exclusion:
-Must not have any known major illnesses in the past.
-Past 48 hours – Not taken any antibiotics or any other medications (Allopathic or Ayurveda or Sidha or Homeo).
-Past 24 hours – Not taken alcoholic beverages.
-Present – Not suffering from cough, influenza or sore throat, common cold.
-Women should not be pregnant or breast feeding her child.

For cancer patients
-Uncontrolled diabetes mellitus, recent significant cardiac disease or active serious infection, evidence of brain tumors or brain metastases at the time of screening, known HIV infection, recent use (within 30 days) of immunosuppressive agents other than steroids, prior history of stem cell transplantation and prior history of fludarabine therapy.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The stratify cohort of healthy volunteers and cancer patients as per cancer killing activity (%) (Both CKA1 and CKA 2).   At baseline. 
 
Secondary Outcome  
Outcome  TimePoints 
• Correlation of markers of cytolysis/ necrosis produced by granulocytes with cancer cell kill in both cohorts.
• Correlation of expression of markers of apoptosis (cleaved caspase 3) by granulocytes for causing apoptosis of cancer cells in both cohorts.
• Demonstration of cell-cell contact requirement for cancer killing activity by granulocytes in both cohorts.
 		 At baseline 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   25/09/2014 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

The proposed study is an “intention to treat” protocol and aims to determine and correlate cancer killing activity with effector mechanisms of human granulocytes of normal healthy individuals, as compared to the control population (cancer patients). 

 
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