| CTRI Number |
CTRI/2020/04/024901 [Registered on: 28/04/2020] Trial Registered Prospectively |
| Last Modified On: |
28/04/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the changes in quality of life of patients undergoing curative surgery for esophageal cancer and the factors related to it. |
|
Scientific Title of Study
|
Pattern of care and quality of life in patients undergoing esophagectomy at Regional Cancer Centre, Thiruvananthapuram |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chandramohan K |
| Designation |
Additional Professor |
| Affiliation |
Regional Cancer Centre, Thiruvananthapuram |
| Address |
Dept. of Surgical Oncology
Regional Cancer Centre
Thiruvananthapuram
Thiruvananthapuram
KERALA
695013
India |
| Phone |
9895774393 |
| Fax |
|
| Email |
drchandramohan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Faheem Abdulla |
| Designation |
Senior resident |
| Affiliation |
Regional Cancer Centre, Thiruvananthapuram |
| Address |
Dept. of Surgical Oncology
Regional Cancer Centre
Thiruvananthapuram
Thiruvananthapuram
KERALA
695013
India |
| Phone |
9447405963 |
| Fax |
|
| Email |
faheem99@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Faheem Abdulla |
| Designation |
Senior Resident |
| Affiliation |
Regional Cancer Centre, Thiruvananthapuram |
| Address |
Dept. of Surgical Oncology
Regional Cancer Centre
Thiruvananthapuram
Thiruvananthapuram
KERALA
695013
India |
| Phone |
9447405963 |
| Fax |
|
| Email |
faheem99@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Regional Cancer Centre, Thiruvananthapuram |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
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 Chandramohan K |
Regional Cancer Centre |
Dept. of Surgical Oncology,
Thiruvananthapuram,
Kerala
Thiruvananthapuram
KERALA |
9895774393
drchandramohan@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 |
Esophageal Cancer, (1) ICD-10 Condition: C159||Malignant neoplasm of esophagus, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Biopsy proven esophageal cancer undergoing curative esophagectomy at Regional Cancer Centre, Thiruvananthapuram. |
|
| ExclusionCriteria |
| Details |
Metastatic patients
Those who can’t comprehend the QoL questionnaires or who are too ill to complete them. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in quality of life in patients undergoing esophagectomy. |
Changes in quality of life in patients undergoing esophagectomy will be assessed at baseline(pre-op) and at 1 and 6 months post-surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Factors affecting the changes in quality of life. |
At baseline, 1 month and 6 months after surgery. |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
30/04/2020 |
| 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="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Aim of the study is to prospectively evaluate pattern of care and quality of life in patients undergoing esophagectomy in Regional cancer centre, a tertiary care cancer centre in India |