| CTRI Number |
CTRI/2010/091/000451 [Registered on: 10/05/2010] |
| Last Modified On: |
|
| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
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| Study Design |
Other |
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Public Title of Study
|
Application of proteomics to aid biomarker discovery in smear positive patients of P.vivax and P.falciparum malaria |
|
Scientific Title of Study
|
Application of proteomics to aid biomarker discovery in smear positive patients of P.vivax and P.falciparum malaria |
| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Nithya Gogtay |
| Designation |
|
| Affiliation |
|
| Address |
Department of Clinical Pharmacology, 1st floor, New MS Building,
Seth GS Medical College & KEM Hospital, Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
+91-22-24133767 |
| Fax |
+91-22-24112871 |
| Email |
njgogtay@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Nithya Gogtay |
| Designation |
|
| Affiliation |
Associate Professor |
| Address |
Department of Clinical Pharmacology, 1st floor, New MS Building,
Seth GS Medical College & KEM Hospital, Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
+91-22-24133767 |
| Fax |
+91-22-24112871 |
| Email |
njgogtay@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Nithya Gogtay |
| Designation |
|
| Affiliation |
|
| Address |
Department of Clinical Pharmacology, 1st floor, New MS Building,
Seth GS Medical College & KEM Hospital, Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
+91-22-24133767 |
| Fax |
+91-22-24112871 |
| Email |
njgogtay@hotmail.com |
|
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Source of Monetary or Material Support
|
| Department of Biosciences and Bioengineering, Indian Institute of Technology (IIT), Powai, Mumbai- 400076 |
|
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Primary Sponsor
|
| Name |
Department of Biosciences and Bioengineering, Indian Institute of Technology (IIT), Powai, Mumbai- 400 076 |
| Address |
|
| Type of Sponsor |
|
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
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Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Nithya Gogtay |
Department of Clinical Pharmacology |
Dept. of Clinical Pharmacology, 1st floor, New MS Building,,Seth GS Medical College & KEM Hospital, Parel-400012
Mumbai
MAHARASHTRA |
+91-22-24133767
+91-22-24112871
njgogtay@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee for Research on Human Subjects (ECRHS), Seth GS Medical College & KEM Hospital, Parel, Mumbai |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Malaria is a major health problem in Asia and Africa, and to date more than 1 million people die annually due to this disease. Lack of very effective early diagnostic tests and vaccine, as well as drug resistance for the existing effective anti‐malaria drugs are still major challenges. Proteomic investigations of patient samples might significantly advance our understanding of malarial pathogenesis within the human host, and aid in early diagnostic and perhaps provide prognostic indicators of response., |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
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Inclusion Criteria
|
| Age From |
|
| Age To |
|
| Gender |
|
| Details |
1. Patients of either sex, aged 18-65 years both inclusive
2. Patients with P. vivax or P. falciparum parasitemia more than 1000 parasites/microliter
3. Those willing to provide written informed consent and comply with protocol requirements |
|
| ExclusionCriteria |
| Details |
1. Patients with history of significant systemic diseases like autoimmune disorders, chronic liver diseases, psychiatric illness and bleeding disorders etc. as judged by history and physical examination.
2. Severe/complicated malaria as per WHO criteria
3. Subjects unwilling to consent for the study
4. Malaria patients having mixed infection (both P.vivax and P.falciparum) in peripheral smear
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| To obtain the global proteome profile of P. falciparum and P.vivax |
6 months |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
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Target Sample Size
|
Total Sample Size="100"
Sample Size from India=""
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)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/05/2010 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
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Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
|
This is a prospective study wherein 50 patients with smear positive for P. vivax and 50 with smear positive for P. falciparum will be enrolled. Thereafter 5 ml of heparinized blood sample will be collected and stored at -20 degree celsius pending proteomic analysis. The primary outcome is to to obtain the global proteome profile and compare the proteomic profile of P. vivax versus P. falciparum malaria. This will help in biomarker discovery for malaria. |