| CTRI Number |
CTRI/2025/01/079390 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
19/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
To study risk factors, etiology and management of cancer endometrium |
|
Scientific Title of Study
|
CLINICOPATHOLOGICAL STUDY OF CARCINOMA ENDOMETRIUM |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Madiha khan |
| Designation |
Postgraduate |
| Affiliation |
MAMC DELHI |
| Address |
Lok Nayak Resident Doctors Hostel Delhi
New Delhi
DELHI
110002
India |
| Phone |
09914404716 |
| Fax |
|
| Email |
madihalaure@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Latika Sahu |
| Designation |
Director Professor |
| Affiliation |
Lok Nayak Hospital |
| Address |
Department of Obstetrics and Gynecology, Lok Nayak Hospital, Bahadur shah Zafar Marg
Central
DELHI
110002
India |
| Phone |
9968604400 |
| Fax |
|
| Email |
Latikasahu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Latika Sahu |
| Designation |
Director Professor |
| Affiliation |
Lok Nayak Hospital |
| Address |
Department of Obstetrics and Gynecology, Lok Nayak Hospital Delhi
Central
DELHI
110002
India |
| Phone |
9968604400 |
| Fax |
|
| Email |
Latikasahu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lok Nayak Hospital, Bahadur Shah Zafar Marg, Delhi (110002), India |
|
|
Primary Sponsor
|
| Name |
Lok Nayak Hospital |
| Address |
Bahadur Shah Zafar Marg, Delhi 110002, India |
| Type of Sponsor |
Government medical college |
|
|
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 Madiha Khan |
Maternity block, department of Obstetrics and Gynecology, Lok Nayak Hospital |
Bahadur Shah Zafar Marg, 110002 Delhi, India
New Delhi
DELHI |
9914404716
madihalaure@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITEE MAULANA AZAD MEDICAL COLLEGE DELHI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N998||Other intraoperative and postprocedural complications and disorders of genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
42.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Female |
| Details |
• Histopathological confirmed cases of carcinoma endometrium (retrospective cases of last one year and prospective cases visiting OPD) |
|
| ExclusionCriteria |
| Details |
• Metastatic tumors of endometrium from ovary and cervix |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Demographic and clinicopathological profile of patients with endometrial carcinoma and Treatment modalities (surgery and/or Radiotherapy or chemotherapy or palliative therapy) and response of treatment of patients diagnosed with endometrial cancer at Lok Nayak hospital
|
Demographic and clinicopathological profile of patients with endometrial carcinoma visiting Lok Nayak hospital and Treatment modalities (surgery and/or Radiotherapy or chemotherapy or palliative therapy) and response of treatment 6weeks after surgery of patients diagnosed with endometrial cancer at Lok Nayak hospital and 12months follow up post treatment for any short term complications and residual disease
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
10/03/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
All patients of Endometrial cancer will be included and risk factors, Histopathological features will be noted and followed up till 12months post treatment and the treatment will be given according to latest Departmental and NCCN guidelines |