| CTRI Number |
CTRI/2022/07/043968 [Registered on: 13/07/2022] Trial Registered Prospectively |
| Last Modified On: |
03/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Registry |
| Study Design |
Other |
|
Public Title of Study
|
Metastatic ColoRectal cancer India Registry |
|
Scientific Title of Study
|
A Prospective, Multicenter, Observational Registry of Metastatic Colorectal cancer (mCRC) Disease to determine Demographics, Clinical features, Molecular
features and Treatment outcomes in patients undergoing treatment at participating centers. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rahul Rathod |
| Designation |
Head - Ideation and Clinical Research |
| Affiliation |
Dr Reddys Laboratories Ltd |
| Address |
Medical Affairs Department, Dr Reddys Laboratories Ltd, 7-1-27,
Ameerpet, Hyderabad
Hyderabad
TELANGANA
500016
India |
| Phone |
04049048400 |
| Fax |
04049048800 |
| Email |
Rahul.Rathod@drreddys.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Rohit R Desai |
| Designation |
Team Lead - Medical Advisor |
| Affiliation |
Dr Reddys Laboratories Ltd |
| Address |
Medical Affairs Department, Dr Reddys Laboratories Ltd, 7-1-27,
Ameerpet, Hyderabad
Hyderabad
TELANGANA
500016
India |
| Phone |
04049048400 |
| Fax |
04049048800 |
| Email |
rohit.r@drreddys.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rahul Rathod |
| Designation |
Head - Ideation and Clinical Research |
| Affiliation |
Dr Reddys Laboratories Ltd |
| Address |
Medical Affairs Department, Dr Reddys Laboratories Ltd, 7-1-27,
Ameerpet, Hyderabad
Hyderabad
TELANGANA
500016
India |
| Phone |
04049048400 |
| Fax |
04049048800 |
| Email |
Rahul.Rathod@drreddys.com |
|
|
Source of Monetary or Material Support
|
| Dr Reddys Laboratories Ltd, Medical Affairs Department,
7-1-27, Ameerpet Road, Ameerpet,
Hyderabad
TELANGANA 500016 India |
|
|
Primary Sponsor
|
| Name |
Dr Reddys Laboratories |
| Address |
7-1-27, Ameerpet Hyderabad 500016 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 15 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vamshi Krishna |
AIG Hospitals |
Tower A, B3, Department of Medical Oncology,
AIG Hospitals (A unit of Asian Institute of Gastroenterology),
No 136, Mindspace Road,
Gachibowli, Hyderabad 500032
Hyderabad
TELANGANA |
9959778112
drmvkrishnaonco@gmail.com |
| Dr Anil Jose |
Amala hospital |
Amala Institute of Medical Sciences,
Amala Nagar PO, Thrissur - 680555,
Kerala, INDIA
Thrissur
KERALA |
9446309968
DRANILTJ@YAHOO.CO.IN |
| Dr Prabrajya Mohapatra |
Apollo Multispeciality Hospitals Ltd. |
Department of Oncology, 58, Canal Circular Rd, Kadapara, Phool Bagan, Kankurgachi, Kolkata, West Bengal 700054
Kolkata
WEST BENGAL |
9674311610
prabrajya.mohapatra@rediffmail.com |
| Dr Arun Chandrasekharan |
Aster MIMS |
Malabar Institute of Medical Sciences Ltd. Mini By-pass Road, Govindapuram P.O.
Calicut, Kerala, 673016
Kozhikode
KERALA |
9619340036
groundhogcs@gmail.com |
| Dr SenthilJRajappa |
Basavatarakam Indo American Cancer Hospital & Research Institute |
Room no 121, Road No: 10,Banjara Hills,Hyderabad-500034, India
Hyderabad
TELANGANA |
04023551235
senthilrajappa@gmail.com |
| Dr Soumya Surath Panda |
Institute of Medical Sciences (IMS) and SUM hospital |
Department of Clinical Research, K-8, Kalinga Nagar, Ghatikia, Khandagiri, Bhubaneshwar, Odisha – 751003
Baleshwar
ORISSA |
8895370579
ssp_scb@yahoo.com |
| Dr Amit Rauthan |
Manipal Hospitals |
Department of Oncology,
#98, Old Airport Road, Kodihalli, Bengaluru - 560017
Bangalore
KARNATAKA |
18001023232
amit.rauthan@manipalhospitals.com |
| Dr Boman N Dhabhar |
Masina Hospital |
Oncocentre, Sant Satva Marg, Near Gloria Church, Byculla (East), Mumbai - 400027
Mumbai
MAHARASHTRA |
02261841293
drboman@hotmail.com |
| Dr Narayana Kutty Warrier |
MVR Cancer Institute & Research Centre |
Department of Oncology, CP 13/516 B C, Vellalasasseri, Poolacode, Kozhikode, Kerala - 673601
Kozhikode
KERALA |
04952289500
nk@hotmail.com |
| Dr Chandrakanth MV |
NH-Rabindranath Tagore International Institute of Cardiac Sciences |
Department of Clinical Research
3rd Floor, New Utility Building
NH-Rabindranath Tagore International Institute of Cardiac Sciences,
Premises No 148, (124), Mukundapur, E. M. Bypass, Kolkata - 700099
West Bengal
Kolkata
WEST BENGAL |
7003206633
drmvch@gmail.com |
| Dr Vineet Talwar |
Rajiv Gandhi Cancer Institute & Research Centre |
Department of medical oncology, Sector -5, Rohini, New Delhi – 110085, India
New Delhi
DELHI |
01127051037
drvineettalwar@yahoo.com |
| Dr Vikas Talreja |
Regency Hospital |
Department of Oncology, Regency Hospital Tower-2 Sarvodaya Nagar Kanpur 208005
Kanpur Nagar
UTTAR PRADESH |
05123502525
drvikastelemedicine@gmail.com |
| Dr Tushar Patil |
Sahyadri Super Speciality Hospital |
Sahyadri Super Speciality Hospital, Plot No. 30-C, Erandwane, Karve Road, Deccan Gymkhana, Pune - 411004, Maharashtra, India
Pune
MAHARASHTRA |
02067213000
tussipats@hotmail.com |
| Dr SH Advani |
Sushrut Hospital |
Department of Oncology, 365, Sant Vershaw Kakkaya Marg, Swastik Park, Chembur (East), Mumbai, Maharashtra 400071
Mumbai
MAHARASHTRA |
9821157706
shadvani2000@yahoo.com |
| Dr Pradeep V |
TMC |
Marripalem, Aganampudi Village, Gajuvaka Mandalam, NH16, Visakhapatnam, Andhra Pradesh 530053
Visakhapatnam
ANDHRA PRADESH |
9892962463
pradeepventrapati@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 15 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Basavatarakam Indo American Cancer Hospital & Research |
Approved |
| Institutional Ethics Committee,Aster MIMS |
Submittted/Under Review |
| Ethics Committee of Manipal Hospitals, Bangalore |
Approved |
| Institutional Ethics Committee Apollo |
Approved |
| Institutional Ethics Committee IMS |
Approved |
| Institutional Ethics Committee, AIG |
Approved |
| Institutional Ethics Committee, Amala hospital |
Approved |
| Institutional Ethics Committee, MVR Cancer Institute |
Approved |
| Institutional Ethics Committee, Regency Hospital |
Approved |
| Institutional Ethics Committee, TMC |
Submittted/Under Review |
| IRB Rajiv Gandhi Cancer Institute & Research centre |
Approved |
| Masina Hospital Trust Ethics Committee |
Submittted/Under Review |
| NHRTIICS Ethics Committee |
Approved |
| sahyadri hospital Private Ltd Ethics commitee |
Approved |
| Sushrut Hospital Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C189||Malignant neoplasm of colon, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
ï‚· Metastatic adenocarcinoma of colon or rectum
ï‚· Inoperable and eligible for first line systemic therapy
 Age ≥ 18yrs.
ï‚· Signed informed consent. |
|
| ExclusionCriteria |
| Details |
ï‚· Any participants who received his or her treatment at
participating study sites prior to enrolment except for
patients with metachronous mCRC
ï‚· Non-metastatic Colorectal cancer |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
To understand the clinical profile (e.g. Baseline demographics, Clinical presentations, co-morbid conditions, Performance
status etc.) of Metastatic Colorectal cancer (mCRC) patients undergoing treatment
ï‚· To understand the tumour characteristics (tumour location, Site of metastasis, Number of metastatic sites, Molecular profile [KRAS including KRAS G12C, BRAF, MSI/MSS, HER2 etc) of Metastatic Colorectal cancer (mCRC) patients undergoing
treatment.
ï‚· To understand the current treatment pattern of Metastatic Colorectal cancer (mCRC) patients
ï‚· To understand Treatment outcomes in Metastatic Colorectal cancer (mCRC) patients undergoing treatment |
Baseline(Day 0), Follow up (3-6 months), follw up (12-18 months) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="1000"
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)
|
15/07/2022 |
| 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="4"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is an multicenter, prospective Observational Registry study to determine Demographics, Clinical features, Molecular features and Treatment outcomes in patients undergoing treatment at participating centers who are ≥18 years that will be conducted in India. The objectives will be to understand the clinical profile, tumour characteristics, current treatment pattern of Metastatic Colorectal cancer (mCRC) patients and the outcomes in Metastatic Colorectal cancer (mCRC) patients undergoing treatment. Up to 1000 participants with Metastatic Colorectal Cancer to be enrolled in the Registry from up to 15 centres over a period of 2 years. |