| CTRI Number |
CTRI/2019/02/017622 [Registered on: 12/02/2019] Trial Registered Prospectively |
| Last Modified On: |
11/02/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational |
| Study Design |
Other |
|
Public Title of Study
|
Comparison between inner layer of uterus sample histopathology and Serum Lactate Dehydrogenase levels( enzyme) with histopathology of final uterus specimen in women with mass in uterus undergoing surgery(removal of uterus). |
|
Scientific Title of Study
|
Correlation of Endometrial Curettage Histopathology and Serum Lactate Dehydrogenase Levels with final specimen in women with Fibroids undergoing Hysterectomy. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jampana Pallavi |
| Designation |
Junior resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of obstetrics and Gynaecology, Kasturba Medical College, Madhav nagar, Manipal, Karnataka-576104
Udupi
KARNATAKA
576104
India |
| Phone |
9014955555 |
| Fax |
|
| Email |
pallavi.jampana18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shyamala G |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of obstetrics and Gynaecology, Kasturba Medical College, Madhav nagar, Manipal, Karnataka-576104
Udupi
KARNATAKA
576104
India |
| Phone |
9844551037 |
| Fax |
|
| Email |
shyamala.g@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Jampana Pallavi |
| Designation |
Junior resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of obstetrics and Gynaecology, Kasturba Medical College, Madhav nagar, Manipal, Karnataka-576104
Udupi
KARNATAKA
576104
India |
| Phone |
9014955555 |
| Fax |
|
| Email |
pallavi.jampana18@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Obstetrics and gynecology,kasturba Medical college, Manipal. |
|
|
Primary Sponsor
|
| Name |
Katurba Medical college Manipal |
| Address |
Department of obstetrics and Gynaecology, Kasturba Medical College, Madhav nagar, Manipal, Karnataka-576104 |
| Type of Sponsor |
Private 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 |
| Jampana Pallavi |
Kasturba Hospital, Manipal. |
Department of obstetrics and Gynaecology, Kasturba Medical
College, Madhav nagar, Manipal, Karnataka-576104
Udupi
KARNATAKA |
9014955555
pallavi.jampana18@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
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N858||Other specified noninflammatory disorders of uterus, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Female |
| Details |
Women with fibroids undergoing hysterectomy during study period |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the role of endometrial sampling and LDH levels in diagnosing endometrial pathologies in women with fibroids. |
Outcome will be assesed after the final histopathology report |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Correlation of serum LDH levels in patients with fibroid uterus. |
Outcome will be assesed after final histopathology report. |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
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)
|
24/02/2019 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study will be performed to find if endometrial sampling in women with fibroids would identify associated uterine pathology such as endometrial hyperplasia, polyps, endometrial carcinoma, stromal tumors and leiomyosarcoma. It is also used to identify the correlation between serum LDH and uterine fibroids. |