Effector mechanism anti-cancer response of human granulocytes

Not Applicable

Conditions: Health Condition 1: null- Cancer patients at any stage.

Registration Number: CTRI/2015/03/005605

Lead Sponsor: Munogenics Inc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 200

Inclusion Criteria

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 â?? between 50 and 100 / minute with no irregularities, Blood Pressure â?? Systolic 100- 180 mm Hg and Diastolic 50- 100 mm Hg, oral temperature not exceeding 37.50C, body weight â??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.

Exclusion Criteria

Exclusion:

-Must not have any known major illnesses in the past.

-Past 48 hours â?? Not taken any antibiotics or any other medications (Allopathic or Ayurveda or Sidha or Homeo).

-Past 24 hours â?? Not taken alcoholic beverages.

-Present â?? 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.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The stratify cohort of healthy volunteers and cancer patients as per cancer killing activity (%) (Both CKA1 and CKA 2).Timepoint: At baseline.

Secondary Outcome Measures

Name	Time	Method
â?¢Correlation of markers of cytolysis/ necrosis produced by granulocytes with cancer cell kill in both cohorts. <br/ ><br>â?¢Correlation of expression of markers of apoptosis (cleaved caspase 3) by granulocytes for causing apoptosis of cancer cells in both cohorts. <br/ ><br>â?¢Demonstration of cell-cell contact requirement for cancer killing activity by granulocytes in both cohorts. <br/ ><br>Timepoint: At baseline