| CTRI Number |
CTRI/2021/04/032663 [Registered on: 08/04/2021] Trial Registered Prospectively |
| Last Modified On: |
30/03/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Endometrial cancer - factors affecting disease recurrence |
|
Scientific Title of Study
|
Analysis of Clinicopathologic factors affecting the recurrence on carcinoma endometrium |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anupama |
| Designation |
Professor |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
Dept. of Gynecologic Oncology
Amrita Institute of Medical Sciences
Kochi, Kerala, India
Ernakulam
KERALA
682040
India |
| Phone |
8891728600 |
| Fax |
|
| Email |
anupamarajanbabu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anupama |
| Designation |
Professor |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
Dept. of Gynecologic Oncology
Amrita Institute of Medical Sciences
Kochi, Kerala, India
Ernakulam
KERALA
682040
India |
| Phone |
8891728600 |
| Fax |
|
| Email |
anupamarajanbabu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anupama |
| Designation |
Professor |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
Dept. of Gynecologic Oncology
Amrita Institute of Medical Sciences
Kochi, Kerala, India
Ernakulam
KERALA
682040
India |
| Phone |
8891728600 |
| Fax |
|
| Email |
anupamarajanbabu@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Amrita Institute |
| Address |
Amrita Institute of Medical Sciences , Ernakulam, Kerala |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Anupama R |
Amrita Institute of Medical Sciences |
Ponekkara P O
Ernakulam
Kerala
Ernakulam
KERALA |
8891728600
anupamarajanbabu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Amrita Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C541||Malignant neoplasm of endometrium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Female |
| Details |
Patients with carcinoma endometrium |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Overall survival at 5 years |
Time of last follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Recurrence free survival |
Date of recurrence |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
28/04/2021 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
to be published after completion of the study |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is an analysis of factors affecting recurrence in patients with endometrial cancer. Once the study is completed we will be providing a summary of the findings and publication details |