| CTRI Number |
CTRI/2025/08/092149 [Registered on: 01/08/2025] Trial Registered Prospectively |
| Last Modified On: |
31/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Establishing rare cancer and exceptional responder network in India to accelerate translational research |
|
Scientific Title of Study
|
RARExCAN: Establishing rare cancer and exceptional responders network in India to accelerate translational research. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Version 1.1 dated 18 Dec 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr CS Pramesh |
| Designation |
Professor, Surgical Oncology, Director, Tata Memorial Hospital |
| Affiliation |
Tata Memorial Hospital,Mumbai |
| Address |
Room No 54, Director’s Office,Ground Floor, Main Building ,Tata Memorial Hospital. Dr. Ernest Borges
Marg, Parel East, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177000 |
| Fax |
02224146937 |
| Email |
prameshcs@tmc.gov.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr CS Pramesh |
| Designation |
Professor, Surgical Oncology, Director, Tata Memorial Hospital |
| Affiliation |
Tata Memorial Hospital,Mumbai |
| Address |
Room No 54, Director’s Office,Ground Floor, Main Building ,Tata Memorial Hospital. Dr. Ernest Borges
Marg, Parel East, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177000 |
| Fax |
02224146937 |
| Email |
prameshcs@tmc.gov.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr CS Pramesh |
| Designation |
Professor, Surgical Oncology, Director, Tata Memorial Hospital |
| Affiliation |
Tata Memorial Hospital,Mumbai |
| Address |
Room No 54, Director’s Office,Ground Floor, Main Building ,Tata Memorial Hospital. Dr. Ernest Borges
Marg, Parel East, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177000 |
| Fax |
02224146937 |
| Email |
prameshcs@tmc.gov.in |
|
|
Source of Monetary or Material Support
|
| CSR supported by Axis Bank |
|
|
Primary Sponsor
|
| Name |
Axis Bank |
| Address |
Axis House, Wadia International Centre, Pandurang Budhkar Marg, Worli, Mumbai 400 025 |
| Type of Sponsor |
Other [Supported by CSR Grant] |
|
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Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Bibhuti Borthakur |
Dr. Bhubaneswar Borooah Cancer Institute |
AK Azad Road, Gopinath Nagar Rd, Bishnu Rabha Nagar, Guwahati, Assam 781016
Kamrup
ASSAM |
917578998114
borthakur.bb@gmail.com |
| Dr CS Pramesh |
Tata Memorial Hospital, Mumbai |
National Cancer Grid office, 10th floor, Homi Bhabha Building, Tata Memorial Hospital, Parel,Mumbai
Mumbai
MAHARASHTRA |
02224177000
02224146937
prameshcs@tmc.gov.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C858||Other specified types of non-Hodgkin lymphoma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Any patient that fits the rare cancer definition as per the protocol which is, Rare Cancers will be defined as those with incidence of less than 6 cases per 100,000, rare pathological subtypes of common cancers,pediatric cancers,hematological cancers and unusual site or age at presentation.
2. Willing to give consent. |
|
| ExclusionCriteria |
| Details |
1. Not willing to give consent.
2. If received any prior treatment. |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Establishing a complete clinical database for rare cancers and exceptional responders.
2. Establishing biorepository of all clinically annotated rare cancers and exceptional responders for exploration of biological basis.
3.Analyzing patterns of care and outcomes of rare cancers and exceptional responders versus others.
4.Improving the outcomes of rare cancers through delivery of uniform care
|
1. Continuous process, At the end of 5 years, the data will be analyzed to understand the prevalence and pattern of rare cancers in the network along with treatment outcomes.
2. All the biopsy/surgical specimens at the hub/spokes will be collected over 10 years.
3. The data entered in the clinical database linked to the virtual biobank will be analyzed at 3, 5 and 10 years from the start of the project.
4. The follow up of the cases discussed will be provided at periodic intervals (every 6 months) as a consolidated report. The database will be updated every 6 months for the treatment plan, treatment given, response and the outcome.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Evaluate novel study designs for conduct of clinical trials in rare cancers
Capacity building & training in the management & research of rare cancers
|
Nil |
|
|
Target Sample Size
|
Total Sample Size="8000"
Sample Size from India="8000"
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)
|
20/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/08/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="10"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
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Brief Summary
|
Rare cancers are uncommon individually but collectively contribute to a significant portion of cancer cases and deaths worldwide. These cancers are challenging to diagnose and treat because of delays in diagnosis, misdiagnosis, limited research, and lack of standardized treatment options. This project aims to address these issues by creating a collaborative network of cancer centers across India, linked through a "hub and spoke" model.The project will focus on improving diagnosis by enabling expert review of pathology reports and advanced molecular testing at specialized centers (hubs). It will establish a shared database to collect detailed clinical and biological information on patients with rare cancers and those who respond exceptionally well to treatment. This will help researchers understand the unique biology of these cancers and develop more effective, personalized treatments.The network will also create a biobank to store tumor and normal tissue samples for future research and support clinical trials tailored to rare cancers. Additionally, expert multidisciplinary teams will provide guidance on treatment plans for complex cases through virtual tumor boards/MDT meetings. Training programs, educational resources, and recorded sessions will help build expertise among healthcare professionals nationwide.By streamlining diagnosis, improving treatment strategies, and fostering research collaborations, the project aims to significantly improve outcomes for patients with rare cancers, advance scientific understanding, and build capacity for managing these cancers effectively in India.
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