| CTRI Number |
CTRI/2024/04/066464 [Registered on: 29/04/2024] Trial Registered Prospectively |
| Last Modified On: |
18/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
interview |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To develop HRQoL module for metastatic and recurrent/ persistent anal cancer |
|
Scientific Title of Study
|
A feasibility study to develop a HRQoL module for metastatic and recurrent/ persistent anal cancer or to add metastatic anal cancer-specific items to the existing EORTC QLQ-ANL27 |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IRAS ID 328317 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rahul Krishnatry |
| Designation |
Professor |
| Affiliation |
Tata Memorial Centre |
| Address |
Room No 1125, HBB
Tata memorial centre, Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
|
| Fax |
|
| Email |
krishnatry@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rahul Krishnatry |
| Designation |
Professor |
| Affiliation |
Tata Memorial Centre |
| Address |
Room No 1125, HBB, Department of radiation oncology,
Tata memorial centre, Parel
Room No 1125, HBB, Department of radiation oncology,
Tata memorial centre, Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
222222271 |
| Fax |
|
| Email |
krishnatry@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rahul Krishnatry |
| Designation |
Professor |
| Affiliation |
krishnatry@gmail.com |
| Address |
Room No 1125, HBB, Department of Radiation Oncology,
Tata memorial centre, Parel
Room No 1125, HBB, Department of Radiation Oncology,
Tata memorial centre, Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
222222271 |
| Fax |
|
| Email |
krishnatry@gmail.com |
|
|
Source of Monetary or Material Support
|
| European Organisation for Research and Treatment of Cancer
83/11, Avenue E Mounier, 1200 Brussels, Belgium |
|
|
Primary Sponsor
|
| Name |
European Organisation for Research and Treatment of Cancer |
| Address |
European Organisation for Research and Treatment of Cancer 83/11, Avenue E Mounier, 1200 Brussels, Belgium |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Tata Memorial centre |
Parel, Mumbai, India |
|
|
Countries of Recruitment
|
Austria
Belgium
United Kingdom |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rahul Krishnatry |
Tata Memorial centre |
room 1125
department radiation oncology,
TMH, Parel, mumbai
Mumbai
MAHARASHTRA |
222222771
krishnatry@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tata Memorial Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C210||Malignant neoplasm of anus, 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 |
1. Patients with a confirmed diagnosis of metastatic and/ or recurrent/persistent anal cancer managed by systemic treatment
2. Are aware of their diagnosis and treatment plan
3. Able to understand the language of the questioning
4. Aged 18 years or above
5. Receiving or having received treatment within the last 2 years
6. Patients who are willing and able to give fully informed consent to participate
7. No other diagnosed cancer |
|
| ExclusionCriteria |
| Details |
1. Poor command of the English language
2. Patients under the age of 18
3. Diagnosis with other cancers within the last 5 years
4. Patients taking part in a clinical trial for non-approved drugs
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Establish a preliminary item list of issues that are relevant to patients withmetastatic or recurrent/ persistent anal cancer.
2. Establish which of the items on the preliminary item list are already represented in the EORTC item library, or existing EORTC quality of life modules. |
1. Establish a preliminary item list of issues that are relevant to patients withmetastatic or recurrent/ persistent anal cancer.
2. Establish which of the items on the preliminary item list are already represented in the EORTC item library, or existing EORTC quality of life modules. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
NA |
|
|
Target Sample Size
|
Total Sample Size="55"
Sample Size from India="8"
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)
|
22/05/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
22/05/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
We are running a study looking at how cancer and its treatment can have an impact on your quality of life. The study involves a short interview whereby aspects of your life affected by cancer and its treatments will be explored. Taking part involves reviewing a number of quality of life issues which have been identified as being important to patients with metastatic or recurrent/ persistent anal cancer in a previous phase of this study. You will be asked to take part in an interview to rate these issues according to whether you consider they are important and relevant to yourself and other patients. We are seeking to identify heath-related quality of life issues of most importance and relevance to patients with metastatic or recurrent/ persistent anal cancer treated with systemic therapies. This will help us to make a decision about whether there needs to be a specific Quality of Life questionnaire for patients with these diagnoses or whether the current EORTC QLQ-ANL27 questionnaire for patients with anal cancer can be supplemented with additional items.
|