CTRI/2015/03/005605RecruitingNot Applicable
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
Munogenics Inc1 site in 1 country200 target enrollmentStarted: September 25, 2014Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- The stratify cohort of healthy volunteers and cancer patients as per cancer killing activity (%) (Both CKA1 and CKA 2).
Study Overview
Brief Summary
The proposed study is an“intention to treat†protocol and aims to determine and correlate cancerkilling activity with effector mechanisms of human granulocytes of normalhealthy individuals, as compared to the control population (cancer patients).
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 40.00 Year(s) (—)
- Sex
- All
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 – 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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
The stratify cohort of healthy volunteers and cancer patients as per cancer killing activity (%) (Both CKA1 and CKA 2).
Time Frame: At baseline.
Secondary Outcomes
- •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.)
Investigators
Study Sites (1)
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