| CTRI Number |
CTRI/2024/02/062574 [Registered on: 13/02/2024] Trial Registered Prospectively |
| Last Modified On: |
04/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To study the clinical profile of patients with carcinoma esophagus in a rural tertiary care hospital |
|
Scientific Title of Study
|
Clinical profile of patients with carcinoma esophagus in a tertiary care center |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anusha Gupta |
| Designation |
Senior Resident |
| Affiliation |
Datta Meghe Institute Of Higher Education And Research |
| Address |
Department of Gastroenterology, Jawaharlal Nehru Medical College, Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
9860575190 |
| Fax |
|
| Email |
dranushagupta92@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijendra Kirnake |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute Of Higher Education And Research |
| Address |
Department of Gastroenterology, Jawaharlal Nehru Medical College, Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
9860575190 |
| Fax |
|
| Email |
drvijendrakirnake@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anusha Gupta |
| Designation |
Senior Resident |
| Affiliation |
Datta Meghe Institute Of Higher Education And Research |
| Address |
Department of Gastroenterology, Jawaharlal Nehru Medical College, Sawangi Meghe
MAHARASHTRA
442001
India |
| Phone |
9860575190 |
| Fax |
|
| Email |
dranushagupta92@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical College and Acharya Vinoba Bhave Rural Hospital |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Nehru Medical College |
| Address |
Sawangi Meghe, Wardha, Maharashtra |
| 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 |
| Dr Anusha Gupta |
Datta Meghe Institute Of Higher Education and Research |
Department of Gastroenterology, C block 1st floor
Acharya Vinobha Bhave Rural Hospital, Jawaharlal Nehru Medical College, DMIHER Sawangi Meghe Wardha Maharashtra
Wardha
MAHARASHTRA |
9860575190
dranushagupta92@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C159||Malignant neoplasm of esophagus, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All patients presenting to Gastroenterology OPD or emergency with dysphagia who were diagnosed as having Carcinoma esophagus were included in the study. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Overall survival of the patients
Disease prognostication |
Baseline, 3 months, 6 months, 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
factors causing the disease
location of carcinoma
correlation of location to overall survival
available treatment options
effect of treatment on survival |
3 months, 6 months, 9 months, 12 months |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
19/02/2024 |
| 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 Yet Recruiting |
| 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
|
Esophageal malignancy is a rapidly growing malignancy worldwide. There are several risk factors for the same depending upon the two histological types of the malignancy. Also, newer treatment options are being employed like, endoscopic management for end stage carcinoma (palliation). In this study we will be seeing the most common clinical presentation of the patients followed by the risk factors for disease development, the current treatment options available, the overall effect of the treatment options on the survival of the patients and treatment for end stage malignancy. Although it is a very rapidly growing malignancy, it is not well researched and therefore this study is very important. |