| CTRI Number |
CTRI/2024/06/068795 [Registered on: 12/06/2024] Trial Registered Prospectively |
| Last Modified On: |
07/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Non-Compliance of CNS tumor patients to adjuvant treatment. |
|
Scientific Title of Study
|
Non-Compliance to adjuvant radio(chemo)therapy and scheduled follow-up in patients with central nervous system tumors |
| Trial Acronym |
CRIMSON |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NA |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Tejpal Gupta |
| Designation |
Professor and Radiation oncologist Tata Memorial Hospital |
| Affiliation |
Tata Memorial Hospital |
| Address |
HBB ground Floor , Room no. 56,Tata Memorial Hospital, Dr E Borges Road, Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
|
| Fax |
|
| Email |
tejpalgupta@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tejpal Gupta |
| Designation |
Professor and Radiation oncologist Tata Memorial Hospital |
| Affiliation |
Tata Memorial Hospital |
| Address |
HBB ground Floor , Room no. 56,Tata Memorial Hospital, Dr E Borges Road, Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177000 |
| Fax |
|
| Email |
tejpalgupta@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tejpal Gupta |
| Designation |
Professor and Radiation oncologist Tata Memorial Hospital |
| Affiliation |
Tata Memorial Hospital |
| Address |
HBB ground Floor , Room no. 56,Tata Memorial Hospital, Dr E Borges Road, Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177000 |
| Fax |
|
| Email |
tejpalgupta@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Hospital
Dr E Borges Marg
Parel,
Mumbai -400012
India |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital |
| Address |
Dr E Borges Road,
Parel
Mumbai- 400012 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Tejpal Gupta |
Tata Memorial Hospital |
Dr E Borges Road,
Homi Bhabha Block, Ground floor, OPD 056,
Parel, Mumbai 400012
Mumbai
MAHARASHTRA |
02224177000
tejpalgupta@rediffmail.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: G969||Disorder of central nervous system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NA |
NA |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
The patients who have been diagnosed with CNS tumors in TMC (TMH and ACTREC) and completed Radiation treatment.
|
|
| ExclusionCriteria |
| Details |
Patients who did not undergo RT
Patients who have been referred outside of TMC for follow-up.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To analyze the rate of noncompliance to adjuvant radio chemotherapy and scheduled follow-up in patients with central nervous system tumors |
After the completion of therapy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To determine the factors that cause noncompliance for the followup to adjuvant
radiochemotherapy and scheduled follow-up in patients with central nervous system tumors.
To analyse if the trial patients have a better follow up compliance rate then non trial patients.
|
post radiotherapy completion |
|
|
Target Sample Size
|
Total Sample Size="5000"
Sample Size from India="5000"
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)
|
28/06/2024 |
| 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="2"
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
|
Tumors affecting the central nervous system constitute approximately 2percent of all malignancies. Radiation therapy is a crucial treatment modality, including for primary brain tumors, meningiomas, and brain metastases. After completing radiation treatment, regular follow-ups become essential to assess the treatment’s effectiveness and look for any potential side effects or tumor recurrence. Patients who do not follow their scheduled follow-up plan, fall under the category of noncompliant patients. The reason for non-compliance can be social, financial, or logistical challenges, by studying these reasons and patterns and rate of noncompliance, the health care providers can find ways to overcome these factors and support patients better, making the process smoother and improving the overall quality of life for patients.
|