Metastatic ColoRectal cancer India Registry

Recruiting

Conditions: Malignant neoplasm of colon, unspecified,

Registration Number: CTRI/2022/07/043968

Lead Sponsor: Dr Reddys Laboratories

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 â‰¥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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 1000

Inclusion Criteria

ï‚· Metastatic adenocarcinoma of colon or rectum ï‚· Inoperable and eligible for first line systemic therapy ï‚· Age â‰¥ 18yrs.
ï‚· Signed informed consent.

Exclusion Criteria

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.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To understand the clinical profile (e.g. Baseline demographics, Clinical presentations, co-morbid conditions, Performance	Baseline(Day 0), Follow up (3-6 months), follw up (12-18 months)
status etc.) of Metastatic Colorectal cancer (mCRC) patients undergoing treatment	Baseline(Day 0), Follow up (3-6 months), follw up (12-18 months)
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	Baseline(Day 0), Follow up (3-6 months), follw up (12-18 months)
treatment.	Baseline(Day 0), Follow up (3-6 months), follw up (12-18 months)
ï‚· To understand the current treatment pattern of Metastatic Colorectal cancer (mCRC) patients	Baseline(Day 0), Follow up (3-6 months), follw up (12-18 months)
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 Measures

Name	Time	Method

Trial Locations

Locations (15): AIG Hospitals
🇮🇳
Hyderabad, TELANGANA, India
Amala hospital
🇮🇳
Thrissur, KERALA, India
Apollo Multispeciality Hospitals Ltd.
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Kolkata, WEST BENGAL, India
Aster MIMS
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Kozhikode, KERALA, India
Basavatarakam Indo American Cancer Hospital & Research Institute
🇮🇳
Hyderabad, TELANGANA, India
Institute of Medical Sciences (IMS) and SUM hospital
🇮🇳
Baleshwar, ORISSA, India
Manipal Hospitals
🇮🇳
Bangalore, KARNATAKA, India
Masina Hospital
🇮🇳
Mumbai, MAHARASHTRA, India
MVR Cancer Institute & Research Centre
🇮🇳
Kozhikode, KERALA, India
NH-Rabindranath Tagore International Institute of Cardiac Sciences
🇮🇳
Kolkata, WEST BENGAL, India
Scroll for more (5 remaining)
AIG Hospitals
🇮🇳Hyderabad, TELANGANA, India
Dr Vamshi Krishna
Principal investigator
9959778112
drmvkrishnaonco@gmail.com