| CTRI Number |
CTRI/2023/04/051709 [Registered on: 18/04/2023] Trial Registered Prospectively |
| Last Modified On: |
19/12/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
RETROSPECTIVE STUDY |
| Study Design |
Other |
|
Public Title of Study
|
A STUDY TO DETERMINE THE CLINICAL FEATURES AND MANAGEMENT OF CARCINOMA ENDOMETRIUM PATIENTS |
|
Scientific Title of Study
|
"Real World Clinical Profile And Outcomes Of
Endometrial Cancers From Tertiary Hospital From Northwest India. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ASHWIN OOMMEN PHILIPS |
| Designation |
consultant medical oncology |
| Affiliation |
MOHANDAI OSWAL HOSPITAL, LUDHIANA |
| Address |
Mohandai Oswal hospital Ludhiana, and Associate professor head Medical Oncology, CMC Ludhiana
BROWN ROAD
Ludhiana
PUNJAB
141008
India |
| Phone |
9003635373 |
| Fax |
|
| Email |
drashphilsmog@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ASHWIN OOMMEN PHILIPS |
| Designation |
consultant medical oncology |
| Affiliation |
MOHANDAI OSWAL HOSPITAL, LUDHIANA |
| Address |
Mohandai Oswal hospital Ludhiana, and Associate professor head Medical Oncology, CMC Ludhiana
BROWN ROAD
Ludhiana
PUNJAB
141008
India |
| Phone |
9003635373 |
| Fax |
|
| Email |
drashphilsmog@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ASHWIN OOMMEN PHILIPS |
| Designation |
consultant medical oncology |
| Affiliation |
MOHANDAI OSWAL HOSPITAL, LUDHIANA |
| Address |
Mohandai Oswal hospital Ludhiana, and Associate professor head Medical Oncology, CMC Ludhiana
BROWN ROAD
Ludhiana
PUNJAB
141008
India |
| Phone |
9003635373 |
| Fax |
|
| Email |
drashphilsmog@gmail.com |
|
|
Source of Monetary or Material Support
|
| MOHANDAI OSWAL HOSPITAL, LUDHIANA |
|
|
Primary Sponsor
|
| Name |
ASHWIN OOMMEN PHILIPS |
| Address |
MOHANDAI OSWAL HOSPITAL, LUDHIANA |
| 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 |
| ASHWIN OOMMEN PHILIPS |
MOHANDAI OSWAL HOSPITAL |
DEPARTMENT OF MEDICAL ONCOLOGY, 2ND FLOOR , ROOM NO: 40
Ludhiana
PUNJAB |
9003635373
drashphilsmog@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mohandai Oswal Cancer Treatment Research Foundation , Mohandai Oswal Hospital Sherpur Byepass G.T. Road Ludhiana Ludhiana |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C51-C58||Malignant neoplasms of female genital organs, (2) ICD-10 Condition: C51-C58||Malignant neoplasms of female genital organs, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Female |
| Details |
RETROSPECTIVE STUDY, ON PATIENTS TREATED AT THE CENTER |
|
| ExclusionCriteria |
| Details |
NON ENDOMETRIAL CANCERS,
AGE LESS THAN 18.
PATIENTS TREATED AT ANOTHER CENTER |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| CLINICOPATHOLOGICAL PROFILE , PROGRESSION FREE SURVIVAL AND OVERAL ALL SURVIVAL |
BASELINE,12 MONTHS, 24 MONTHS, 36 MONTHS , 48 MONTHS AND 60 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| PROGRESSION FREE SURVIVAL AND OVERAL ALL SURVIVAL |
BASELINE, 12 MONTHS, 24 MONTHS, 36 MONTHS, 48 MONTHS, 60 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
24/04/2023 |
| 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="5"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Applicable |
|
Publication Details
|
NOT YET |
|
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 - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drashphilsmog@gmail.com].
- For how long will this data be available start date provided 01-10-2023 and end date provided 01-10-2026?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Endometrial cancer is the most gynecological cancer diagnosed in the developed world, and most patients present in early stages. Post menopausal bleeding is the most common presentation and surgery is the mainstay of treatment. Survival outcomes are good but there is limited data from India , especially North west India. Aims and objectives 1) To evaluate the clinicopathological profile of patients with carcinoma endometrium managed at tertiary cancer hospital Punjab. 2) To determine the progression free survival (PFS) and overall survival (OS) for patients with carcinoma endometrium.
Methods Retrospective chart review will done from Mohandai Oswal hospital (MOH) for patients with biopsy proven carcinoma endometrium aged > 18 years , who have at least taken one modality of treatment from MOH. Data from electronic and paper bases would be collected from 1st January 2017 till 31st August 2022. The data would record and analysed statistically. Statistical analysis will be done using SPSS software version 22.
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