| CTRI Number |
CTRI/2018/10/016139 [Registered on: 24/10/2018] Trial Registered Prospectively |
| Last Modified On: |
13/12/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
prospective |
| Study Design |
Other |
|
Public Title of Study
|
Developing a Cancer database for Shirdi Sai Baba Cancer and Research Centre. |
|
Scientific Title of Study
|
Development and evaluation of a cancer registry for Shirdi Sai Baba Cancer Hospital and Research Centre. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kanav Khera |
| Designation |
Assistant Professor Senior scale |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Pharmacy Practice, Manipal College Of Pharmaceutical Sciences, Manipal Academy of higher Education, Manipal - 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9036253592 |
| Fax |
|
| Email |
kanavworld@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kanav Khera |
| Designation |
Assistant Professor Senior scale |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Pharmacy Practice, Manipal College Of Pharmaceutical Sciences, Manipal Academy of higher Education, Manipal - 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9036253592 |
| Fax |
|
| Email |
kanavworld@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rinkal Kotadia |
| Designation |
2nd year PharmD (PB) |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Pharmacy Practice, Manipal College Of Pharmaceutical Sciences, Manipal Academy of higher Education, Manipal - 576104
Udupi
KARNATAKA
576104
India |
| Phone |
8655788130 |
| Fax |
|
| Email |
rinkalkotadia@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Kanav Khera Proff |
| Address |
Department of pharmacy practice, Manipal college of pharmaceutical sciences, Manipal |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kanav Khera |
KMC Hospital |
Medicine oncology
Udupi
KARNATAKA |
9036253592
kanavworld@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Any patient irrespective of age and sex diagnosed with cancer. |
|
| ExclusionCriteria |
| Details |
patients not willing to participate |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
A complete, precise and accurate data of all cancer patients would be
registered. |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
A complete, precise and accurate data of all cancer patients would be
registered. |
2 years |
|
|
Target Sample Size
|
Total Sample Size="700"
Sample Size from India="700"
Final Enrollment numbers achieved (Total)= "130"
Final Enrollment numbers achieved (India)="130" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/11/2018 |
| Date of Study Completion (India) |
27/09/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Phase 1: Designing a prototype data collection form. Development of initial draft content of data collection form- By referring articles, textbooks & informal discussion with experts. Phase 2: Validation of data collection form-it has to be given minimum 5 experts for validation along with check list-content validity index:<0.78-discard the question. Reliability test-Crohn bac alpha test. Phase 3: Data collection & Data entry- â— Find out specific cancer cases â— Seek patient consent to collect information after explaining the study and providing Participant Information Sheet â— Information to be collected by and organized accordingly (by no. of cancer cases) Phase 4: Evaluation â— Demographics, social history and treatment parameters were qualitatively analysed Phase 5: Replication into a web-based module -Microsoft SQL was used to synthesize into an interactive website -Copyright filed under diary no: 17735/2019-CO/SW (waiting) |