| CTRI Number |
CTRI/2025/07/091601 [Registered on: 24/07/2025] Trial Registered Prospectively |
| Last Modified On: |
23/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Ambispective observational study |
| Study Design |
Other |
|
Public Title of Study
|
A Worldwide Study on How Children with Retinoblastoma Are Treated and How They Recover |
|
Scientific Title of Study
|
Global Retinoblastoma Presentation (2024) and Outcome (2027) Studies. |
| Trial Acronym |
Global RB Study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Venkata Rama Mohan Gollamudi |
| Designation |
Assistant Professor, Principal Investigator |
| Affiliation |
Tata Memorial Hospital |
| Address |
Tata Memorial Hospital, Department of Medical Oncology- Pediatric Division, Main building, Ground floor, OPD no.80, Room no. 17, Dr. E Borges Road, Parel, Mumbai.400012
Mumbai
MAHARASHTRA
400012
India |
| Phone |
8450976532 |
| Fax |
|
| Email |
vencatram@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Venkata Rama Mohan Gollamudi |
| Designation |
Assistant Professor, Principal Investigator |
| Affiliation |
Tata Memorial Hospital |
| Address |
Tata Memorial Hospital, Department of Medical Oncology- Pediatric Division, Main building, Ground floor, OPD no.80, Room no. 17, Dr. E Borges Road, Parel, Mumbai.400012
Mumbai
MAHARASHTRA
400012
India |
| Phone |
8450976532 |
| Fax |
|
| Email |
vencatram@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Venkata Rama Mohan Gollamudi |
| Designation |
Assistant Professor, Principal Investigator |
| Affiliation |
Tata Memorial Hospital |
| Address |
Tata Memorial Hospital, Department of Medical Oncology- Pediatric Division, Main building, Ground floor, OPD no.80, Room no. 17, Dr. E Borges Road, Parel, Mumbai.400012
Mumbai
MAHARASHTRA
400012
India |
| Phone |
8450976532 |
| Fax |
|
| Email |
vencatram@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Hospital, Dr. E Borges Road, Parel, Mumbai.400012
INDIA |
|
|
Primary Sponsor
|
| Name |
Not applicable |
| Address |
Not applicable |
| Type of Sponsor |
Other [Not applicable ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
United Kingdom
Afghanistan
Albania
Algeria
Angola
Argentina
Armenia
Australia
Austria
Azerbaijan
Bangladesh
Belarus
Belgium
Benin
Bolivia
Bosnia and Herzegovina
Botswana
Brazil
Bulgaria
Burkina Faso
Cambodia
Cameroon
Canada
Central African Republic
Chad
Chile
China
Colombia
Congo
Costa Rica
Cote d'Ivoire
Croatia
Cuba
Czech Republic
Democratic Republic of the Congo
Denmark
Dominican Republic
Ecuador
Egypt
El Salvador
Eritrea
Estonia
Ethiopia
Finland
France
Gabon
Gambia
Georgia
Germany
Ghana
Greece
Guatemala
Guinea
Guinea-Bissau
Guyana
Haiti
Honduras
Hungary
India
Indonesia
Iran (Islamic Republic of)
Iraq
Ireland
Israel
Italy
Jamaica
Japan
Jordan
Kazakhstan
Kenya
Kuwait
Kyrgyzstan
Latvia
Lebanon
Liberia
Lithuania
Madagascar
Malawi
Malaysia
Mali
Mexico
Mongolia
Montenegro
Morocco
Mozambique
Myanmar
Namibia
Nepal
Netherlands
New Zealand
Nicaragua
Niger
Nigeria
Norway
Pakistan
Panama
Paraguay
Peru
Philippines
Poland
Portugal
Republic of Korea
Republic of Moldova
Romania
Russian Federation
Rwanda
Saudi Arabia
Senegal
Serbia
Sierra Leone
Singapore
Slovakia
Slovenia
Somalia
South Africa
Spain
Sri Lanka
Sudan
Suriname
Sweden
Switzerland
Syrian Arab Republic
Taiwan
Tajikistan
Tanzania
Thailand
Timor-Leste
Togo
Trinidad and Tobago
Tunisia
Turkey
Uganda
Ukraine
United Arab Emirates
United States of America
Uruguay
Uzbekistan
Venezuela (Bolivarian Republic of)
Viet Nam
Zambia
Zimbabwe |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Venkata Rama Mohan Gollamudi |
Tata Memorial Hospital |
Department of Medical Oncology- Pediatric Division, Main building, Ground floor, OPD no.80, Room no. 17, Dr. E Borges Road, Parel, Mumbai.400012
Mumbai
MAHARASHTRA |
8450976539
vencatram@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: C692||Malignant neoplasm of retina, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
0.00 Month(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Treatment-naïve patients with retinoblastoma who presented for diagnosis and treatment of their condition in 2024.
The following are obligatory data in order for a patient to be included in the study:
Patient country of residence.
Patient sex.
Right/left/both eyes involved at time of diagnosis.
For the 2027 outcome study, additional data on survival (live/dead) is obligatory.
Example of cases to be included in the study (for all examples below, data on country of residence, sex
and laterality are obligatory):
Patient diagnosed with retinoblastoma during 2024 and received first treatment in 2024.
Patient diagnosed with retinoblastoma during 2024 and was not treated at all due to treatment abandonment.
Patient that presented to a treatment center during 2024 after receiving initial treatment elsewhere during 2024.If the obligatory data (country of residence, sex and laterality) can be traced and recorded, the patient can be included. |
|
| ExclusionCriteria |
| Details |
Example of a cases to be excluded from the study:
Patient for which data on country of residence and /or sex and /or laterality are missing.
A patient diagnosed and treated before 2024 and then came for additional treatment for the same or fellow eye.
Patient that presented to a treatment center in 2024 after receiving primary treatment elsewhere before 2024. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To investigate the clinical stage at time of diagnosis of treatment-naïve children with Rb who present to treatment centers across the world in 2024.
|
At time of diagnosis
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To investigate the treatment outcome of children with Retinoblastoma who were diagnosed in treatment centers across the world in 2024 & followed up for 3 years until 2027 |
At 36 months
|
|
|
Target Sample Size
|
Total Sample Size="8000"
Sample Size from India="54"
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)
|
11/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/01/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
The Global Retinoblastoma Presentation (2024) and Outcome (2027) Studies aim to understand how retinoblastoma (Rb), a type of eye cancer in children, presents worldwide and how well treatments work over time. Retinoblastoma is a serious disease that, if untreated, can spread and become fatal. Past studies have shown that children in low-income countries are often diagnosed later and have worse survival rates than those in high-income countries. This new study, organized by an international research group, will collect data from treatment centers in many countries. It has two phases: Phase 1: 1-year cross sectional data collection and analysis of all treatment-naïve children with retinoblastoma presenting to Rb treatment centres across the world in 2024. Data will be collected by each participating center during 2024 and then submitted for analysis. Phase 2: 3-year prospective data collection and analysis of children diagnosed in treatment centers in 2024 (i.e. Phase I). Data will be collected by each participating center from January 1 2024 to December 31 2026, and submitted for analysis in early 2027. The study will include only new cases diagnosed in 2024, ensuring that essential data like country of residence, sex, and which eye(s) are affected is recorded. Patients who were diagnosed or treated before 2024 will not be included. Researchers will analyze data to compare results across income levels, countries, and treatment centers. The findings will help improve early detection and treatment strategies, potentially saving more lives. |