| CTRI Number |
CTRI/2022/09/045622 [Registered on: 19/09/2022] Trial Registered Prospectively |
| Last Modified On: |
18/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A clinical study of stomach cancer in a tertiary care centre in Chengalpattu district. |
|
Scientific Title of Study
|
A clinicopathological study of carcinoma stomach in a tertiary care centre in Chengalpattu district. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 159(12)2020 |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
JENITH NIVETHITHAN S |
| Designation |
Postgraduate in general surgery |
| Affiliation |
MAPIMS |
| Address |
OP no 6 ground floor
Department of general surgery
melmaruvathur adhiparasakthi institute of medial sciences and research
melmaruvathur
Kancheepuram
TAMIL NADU
603319
India |
| Phone |
8667854564 |
| Fax |
|
| Email |
sjenith19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Umesh Raj S |
| Designation |
professor in general surgery |
| Affiliation |
Melmaruvathur Adhiparasakthi Institute Of medical Sciences And Research |
| Address |
OP no 6 ground floor
Department of general surgery
melmaruvathur adhiparasakthi institute of medial sciences and research
melmaruvathur
Department of general surgery Melmaruvathur Adhiparasakthi Institute Of medical Sciences And Research
Kancheepuram
TAMIL NADU
603319
India |
| Phone |
9894485752 |
| Fax |
044-27528305 |
| Email |
drumeshraj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jenith Nivethithan S |
| Designation |
Postgraduate in general surgery |
| Affiliation |
Melmaruvathur Adhiparasakthi Institute Of medical Sciences And Research |
| Address |
OP no 6 ground floor
Department of general surgery
melmaruvathur adhiparasakthi institute of medial sciences and research
melmaruvathur
Department Of General Surgery
Melmaruvathur Adhiparasakthi Institute Of medical Sciences And Research
Kancheepuram
TAMIL NADU
603319
India |
| Phone |
8667854564 |
| Fax |
044-27528305 |
| Email |
sjenith19@gmail.com |
|
|
Source of Monetary or Material Support
|
| Melmaruvathur adhiparasakthi medical college |
|
|
Primary Sponsor
|
| Name |
Melmaruvathur Adhiparasakthi Institute Of Medical Sciences And Research |
| Address |
DEPARTMENT OF GENERAL SURGERY MAPIMS
MELMARUVATHUR-603319 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Umesh raj |
Department of general surgery mapims
Melmaruvathur |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| JENITH NIVETHITHAN S |
Melmaruvathur Adhiparasakthi Institute Of Medical Science And Research |
DEPARTMENT OF GENERAL SURGERY MAPIMS
MELMARUVATHUR -603319
Kancheepuram
TAMIL NADU |
8667854564
sjenith19@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE(HUMAN STUDIES),MAPIMS,MELMARUVATHUR,TAMILNADU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C169||Malignant neoplasm of stomach, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
patient who belongs to the age group between 20 to 99 years |
|
| ExclusionCriteria |
| Details |
recurrent carcinoma stomach |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| studying the clinical and pathological outcomes in carcinoma stomach |
baseline, 2 weeks and 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| response to the treatment |
4 weeks and 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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)
|
20/09/2022 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Informed Consent Form
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sjenith19@gmail.com].
- For how long will this data be available start date provided 20-06-2022 and end date provided 20-08-2022?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
THIS IS A CASE CONTROL STUDY,TO ASSESS THE STAGING AND SURGICAL MODALITIES OF TREATMENT AND COMPARE THE RESULTS OF CA STOMACH IN CHENGALPATTU DISTRICT.PRIMARY OUTCOME WILL BE BASED ON THE CLINICAL AND PATHOLOGICAL RESULTS.SECONDARY OUTCOME WILL BE THE RESPONSE TO TREATMENT |